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Extra upper limb practice after stroke: a feasibility study

Extra upper limb practice after stroke: a feasibility study Background: There is a need to provide a large amount of extra practice on top of usual rehabilitation to adults after stroke. The purpose of this study was to determine if it is feasible to add extra upper limb practice to usual inpatient rehabilitation and whether it is likely to improve upper limb activity and grip strength. Method: A prospective, single-group, pre- and post-test study was carried out. Twenty adults with upper limb activity limitations who had some movement in the upper limb completed an extra hour of upper limb practice, 6 days per week for 4 weeks. Feasibility was measured by examining recruitment, intervention (adherence, efficiency, acceptability, safety) and measurement. Clinical outcomes were upper limb activity (Box and Block Test, Nine-Hole Peg Test) and grip strength (dynamometry) measured at baseline (week 0) and end of intervention (week 4). Results: Of the 212 people who were screened, 42 (20%) were eligible and 20 (9%) were enrolled. Of the 20 participants, 12 (60%) completed the 4-week program; 7 (35%) were discharged early, and 1 (5%) withdrew. Participants attended 342 (85%) of the possible 403 sessions and practiced for 324 (95%) of the total 342 h. In terms of safety, there were no study-related adverse events. Participants increased 0.29 blocks/s (95% CI 0.19 to 0.39) on the Box and Block Test, 0.20 pegs/s (95% CI 0.10 to 0.30) on the Nine-Hole Peg Test, and 4.4 kg (95% CI 2.9 to 5.9) in grip strength, from baseline to end of intervention. Conclusions: It appears feasible for adults who are undergoing inpatient rehabilitation and have some upper limb movement after stroke to undertake an hour of extra upper limb practice. The magnitude of the clinical outcomes suggests that further investigation is warranted and this study provides useful information for the design of a phase II randomized trial. Trial registration: Australian and New Zealand Clinical Trial Registry (ACTRN12615000665538). Keywords: Rehabilitation, Occupational therapy, Physical therapy, Task-specific motor training Background control [3] and is structured to provide repetitive upper Upper limb activity is necessary for participation in activ- limb practice of specific tasks that are challenging, pro- ities of daily living [1]. More than 80% of stroke survivors gressive and skill-based [4, 5]. Yet the recovery of upper have motor impairments that can include changes to limb activity after stroke is often poor [6] and stroke survi- muscle strength as well as difficulty in controlling move- vors perceive that their time spent in upper limb rehabili- ment [2]. This decrease in muscle strength and control re- tation was not sufficient [7]. sults in a person needing assistance to complete basic There is high-level evidence that an increase in the amount daily activities [1]. Upper limb rehabilitation, therefore, of supervised rehabilitation improves motor outcome for aims to improve both muscle strength and movement stroke survivors [4, 8–10], with four systematic reviews find- ing small to moderate effect sizes [8–10]. One review investi- gated how much extra rehabilitation was required to * Correspondence: e.schneider@alfred.org.au School of Allied Health (Occupational Therapy), College of Science, Health produce a benefit and found that a 240% increase in the and Engineering, La Trobe University, Plenty Road and Kingsbury Drive, amount of usual rehabilitation was needed to ensure that the Melbourne, Victoria 3086, Australia 2 extra rehabilitation improved activity [10]. For example, if 25 Occupational Therapy Department, Alfred Health, 55 Commercial Road, Melbourne, Victoria 3004, Australia min of upper limb rehabilitation per day is usual, an extra 60 Full list of author information is available at the end of the article © The Author(s). 2019 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Schneider et al. Pilot and Feasibility Studies (2019) 5:156 Page 2 of 7 min (a total of 85 min per day) would need to be provided screened for eligibility by a researcher within 72 h of ad- to result in an improvement in upper limb activity. This is al- mission. Patients were eligible if they had a medical most three times the amount of usual rehabilitation and a diagnosis of stroke, were aged over 18 years, had an large amount of extra practice. upper limb activity limitation (defined as < 54 blocks on The challenge now is to determineafeasible waytopro- the Box and Block Test which is a 20% reduction in the vide a large amount of extra practice taking into account normal scores of adults aged 20–80 years) [27], and had staff and resource constraints. Most studies to date have de- some upper limb activity (> Grade 1 wrist extension and livered extra rehabilitation in one-on-one sessions outside > Grade 3 shoulder elevation on manual muscle testing) the usual rehabilitation service [11–21]. This model of de- in order to be able to carry out the practice [28]. Patients livery, however, is not an efficient way to increase the were excluded if they had severe cognitive and/or lan- amount of usual rehabilitation in an inpatient rehabilitation guage defects (Mini Mental Status Examination score ≤ service. The potential to provide extra rehabilitation with- 24) [29], had any medical condition that precluded them out using one-on-one supervised sessions has been ex- participating in a rehabilitation program aimed at upper plored using various strategies such as gaming, group limb activity, or had a discharge date that precluded practice or homework [22–26]. We propose to investigate them completing the 4-week program. For patients who using largely self-directed practice within inpatient rehabili- were initially ineligible (no upper limb activity), screen- tation as a way of increasing the amount of upper limb ing was repeated weekly to establish if they became eli- practice in the subacute phase after stroke. In preparation gible. Age (year), sex (number male), time since stroke for a large, fully-powered randomized trial, it is important (days), side of hemiplegia (number right), living situation to understand the feasibility of recruitment, delivering the (lives alone), education (attended university), cognition intervention and collecting the outcome measures. There- (Mini Mental Status Examination, 0–30) [29], unilateral fore, the primary questions of this study were: special neglect (Albert’s Line Cancellation Test, number of lines left uncrossed) [30], loss of light touch sensation 1. Is it feasible (in terms of recruitment, intervention and (none/some/complete), spasticity (Tardieu Scale Quality measurement) for people who are undergoing of Muscle Reaction, 0–5) [31], contracture (range of mo- inpatient rehabilitation and have some movement in tion at the wrist and elbow), complexity of rehabilitation the upper limb after stroke to undertake an extra hour needs (Rehabilitation Complexity Scale-Extended, 0–20) of upper limb practice, 6 days per week for 4 weeks? [32], and ability to pick up a cup unaided (number) and 2. Is the extra practice likely to improve upper limb walk unaided (number) were collected at baseline to de- activity and grip strength? scribe the sample. Occupational therapists overseeing the extra upper limb Method practice all had experience in neurological rehabilitation Design and were trained in task-specific motor training and the A prospective, single-group, pre- and post-test study was trial intervention prior to study commencement. One ther- conducted at a metropolitan inpatient rehabilitation hos- apist was involved in overseeing the extra upper limb prac- pital in Melbourne, Australia. The participants received tice, with incidental support from two additional therapists. extra upper limb practice for 4 weeks. Outcomes were measured at baseline (week 0) and at the end of inter- Intervention vention (week 4). The design of the study is presented in Participants undertook an extra hour of upper limb prac- Fig. 1. Outcome measures were collected by occupa- tice, 6 days a week (Monday to Saturday) for 4 weeks, con- tional therapists trained in the procedures who were not sisting of two self-directed programs designed to be used blinded to the aims of the study. University and hospital by adults with stroke: the Graded Repetitive Arm Supple- human research ethics committees approved this study. mentary Program (GRASP) and the AbleX [22, 23]. All participants gave written informed consent before GRASP is a self-directed arm and hand program that in- data collection began. corporates strengthening exercises, part practice and prac- tice of whole upper limb activities [22]. GRASP has three Setting levels of difficulty. The level of difficulty prescribed was The study was conducted in one sub-acute rehabilitation determined by participant performance on weekly clinical hospital that has > 25 beds dedicated to multidisciplinary outcome measures and ability to complete half of the tasks inpatient rehabilitation after stroke. at the maximum number of set repetitions [22]. The ther- apist provided the participant with one of six GRASP kits Participants and therapists (manual and equipment) at the start of each session. Consecutive patients admitted for inpatient rehabilita- AbleX is a computer-based upper limb program that was tion with stroke between July 2015 and June 2016 were set up by the therapist on a laptop. Participants hold a Schneider et al. Pilot and Feasibility Studies (2019) 5:156 Page 3 of 7 Fig. 1 CONSORT diagram showing the design and flow of participants through each stage of the study controller in their affected hand or bilaterally to play a complete the required amount of daily practice but could range of computer games designed to promote target- choose to practice for greater or less than 60 min per session. hitting [23]. The computer system provides participants The amount of practice and session duration was tracked with immediate feedback on their performance (accuracy), and recorded by the participant with assistance from the activity time (adherence) and exercise intensity [23]. therapist using a stopwatch and paper diary. Therapists provided direction and encouragement to prac- No other aspects of the multidisciplinary rehabilitation tice, set-up the equipment, checked the quality of the prac- were changed. The amount of usual upper limb rehabilita- tice,and progressed thedifficultyof practicetoensurethe tion that was scheduled on the participant’s timetable by the level of challenge was always high. The amount of support multidisciplinary rehabilitation team was collected. Usual was gradually reduced once the participant could follow the upper limb rehabilitation could include a combination of in- self-directed programs. To set up the equipment, the therap- dividual and group sessions provided by occupational thera- ist provided the participant with a pre-packed GRASP kit or pists and/or physiotherapists targeting task-specific motor laptop. The extra practice could be undertaken at any time training of the affected upper limb. during usual rehabilitation hours (8 a.m. to 5 p.m.), individu- ally or in a group, in the therapy area or a common space in Outcome measures the ward. The timeofthe extrapracticesession wassched- Feasibility uled on the participant’s timetable to ensure the participant The feasibility of the study involved examining recruitment, was ready for each session. Participants were encouraged to intervention (adherence, efficiency, acceptability, and safety) Schneider et al. Pilot and Feasibility Studies (2019) 5:156 Page 4 of 7 and measurement. The feasibility of recruitment was deter- Sample size mined by calculating the proportion of enrolled patients Due to the nature of a feasibility study, a formal sample from the population who were screened for eligibility. Feasi- size calculation was not performed [36]. We aimed to re- bility of the intervention was determined by examining ad- cruit 20 participants as this was considered an adequate herence (the number of sessions attended as a proportion of number to assess the feasibility [37]. the number of possible sessions), efficiency (the amount of practice as a proportion of total minutes), acceptability (par- Data analysis ticipants yes/no responses to 5 statements about the training For participant characteristics and feasibility outcomes, and rating of their acceptability from 0 to 5, Table 2), and descriptive statistics are presented as mean (SD) or safety (the number of adverse events such as fatigue, illness, number (%). For clinical outcomes, paired between-time muscle soreness, or injuries as a proportion of the number differences (week 4 minus week 0) are presented as of sessions attended). If required, an interpreter or non- mean difference (95% CI). When a participant was dis- verbal communication assisted the participant. The feasibility charged home or from the study before week 4, a meas- of measurement involved examining how many participants ure was taken at this time. could be measured for all outcomes. Results Clinical Characteristics of participants Clinical outcomes were upper limb activity and grip Twenty participants aged 63 (SD 17) years, of which 11 strength. Upper limb activity was measured using the Box (55%) were men, participated in the study. Characteris- and Block Test (number of blocks) and the Nine-Hole Peg tics of participants are presented in Table 1. Usual upper Test (s). Grip strength (kg) was measured using dyna- limb rehabilitation was scheduled for a mean of 37 (SD mometry. The Box and Block Test is a timed test of the 26) min per day with 4 (20%) participants scheduled to ability to grasp and release. The instructions for the test receive no upper limb rehabilitation. were standardized according to Mathiowetz et al. [27]. Participants were asked to pick up and move one block at Feasibility a time over a barrier to the other side of the box as quickly Recruitment as possible. The ability to grasp and release was trans- Over an 11-month period, 212 people were screened, 42 ferred to a rate of performance by dividing the number of (20%) were eligible, and 20 (9%) were enrolled. In terms blocks moved by 60 s (number of blocks/s). of retention, at week 4, 7 (35%) participants had already The Nine-Hole Peg Test is a timed test of the ability been discharged home and one (5%) had withdrawn (co- to grasp, manipulate and place small objects with one enrolled in another study and reported fatigue). Partici- hand. The instructions for the test were modified to in- pants completed the extra upper limb practice program corporate additional stopping points [33, 34]. Partici- for a mean of 3 (SD 1) weeks. The flow of participants pants were asked to pick up the 9 pegs one at a time through the study is presented in Fig. 1. and place them in the holes until all nine holes were filled; then remove the 9 pegs one at a time and return them to the tray. The participants were told not to con- Intervention tinue the test if they had placed zero pegs into the holes Removing the 77 sessions missed due to early discharge of at 60 s [33]. The participants were told not to continue seven participants from the study, there were a possible the test if they had not completed the test (placed and 403 sessions. Adherence to the intervention was 85% (i.e., removed all 9 pegs) in 120 s [34]. The number of pegs 342 out of a possible 403 sessions). Forty-five (11%) ses- moved was quantified as 0–18 pegs; either 0–9 pegs sions were missed because of non-attendance (illness, fa- placed into the holes or 10–18 pegs returned to the tray. tigue, visitors); and 15 (4%) sessions were missed because The score was then transferred to a rate of performance the participant withdrew. Efficiency of the intervention by dividing the number of pegs moved by the number of was 95%; i.e., participants completed 324 h of practice seconds to complete or stop the test (pegs/s). during a total of 342 h. Participants undertook a mean of Dynamometry of maximum voluntary contraction of 57 (SD 9) min of extra upper limb practice during a mean grip measures the strength of muscles in the forearm session of 73 (SD 10) min. Acceptability of the interven- and hand. The instructions for the test were standard- tion is presented in Table 2. Overall, the participants were ized according to Horowitz [35]. Grip strength was satisfied (4.8 out of 5.0) with their extra practice. In terms quantified by the number of kilograms achieved. If the of safety, the incidence of fatigue, illness, or muscle sore- participant could register some strength but not enough ness during the 342 intervention sessions was 40 (12%); 32 to reach the first increment on the dynamometer (at 2 (9%) reports of fatigue; 4 (1%) reports of illness; 4 (1%) re- kg), the score was recorded as 1 kg. ports of localized muscle soreness in the affected arm. Schneider et al. Pilot and Feasibility Studies (2019) 5:156 Page 5 of 7 Table 1 Baseline characteristics of participants baseline to end of intervention. There was a mean 4.4 kg (95% CI 2.9 to 5.9) increase in grip strength from base- Characteristic (n = 20) line to end of intervention. Age (year), mean (SD) 63 (17) Sex, n male (%) 11 (55) Discussion Time since stroke (day), mean (SD) 38 (87) This study demonstrates that it appears feasible for people Side of hemiplegia, n right (%) 12 (60) who are undergoing inpatient rehabilitation and have Living situation, n lives alone (%) 9 (45) some movement in the upper limb after stroke to under- Education, n attended university (%) 9 (45) take an extra hour of upper limb practice, 6 days per week until discharge or for up to 4 weeks. Participants attended Cognition (MMSE, 0–30), mean (SD) 28 (2) the majority of sessions, practiced for the majority of ses- Neglect (Albert’s Line Cancelation Test), n (%) 2 (10) sion duration, rated the acceptability of the intervention as Loss of light touch sensation, n (%) high, and reported a low number of adverse events during None 18 (90) the extra upper limb practice. The change observed in the Some 2 (10) clinical outcomes suggests a promising improvement in Complete 0 (0) upper limb activity and grip strength above what might normally be expected [39]. For example, it has been sug- Spasticity (Tardieu Scale Quality of Muscle Reaction, 0–5), mean (SD) gested that time alone accounts for 16% improvement in Wrist flexors 0.15 (0.38) impairments over 6–10 weeks [39]compared with our Biceps 0.2 (0.51) 42% improvement in grip strength and 100% improve- Contracture upper limb, n (%) 3 (15) ment in upper limb activity over 4 weeks. Complexity of rehabilitation needs (RCS, 0–20), mean (SD) 12 (2) This study provided evidence that extra practice was Grasps unaided, n (%) 10 (50) feasible; however, this was not provided within the usual resources provided within the inpatient rehabilitation unit. Walks unaided, n (%) 2 (10) The participants were often unavailable during usual MMSE Mini-Mental Status Exam, RCS Rehabilitation Complexity Scale-Extended working hours, either completing usual daily activities There were no injuries or serious adverse events (study re- (shower, dress, eat), engaged in usual rehabilitation, rest- lated or otherwise). ing, or with family/visitors. Therefore, the extra upper limb practice was often undertaken after usual rehabilita- Measurement tion and before dinner (4.30–5.30 p.m.) and within the Clinical outcomes were collected from all 20 (100%) par- common space in the ward to reduce transportation and ticipants at week 4 or prior to discharge home or where nursing staff could ensure the safety of the partici- withdrawal. pants during self-directed practice. Seventy-two percent of the self-directed practice was undertaken in a group in the Clinical ward. We recommend that future trials designed to deliver The group clinical outcomes are presented in Table 3. extra upper limb practice to adults undergoing inpatient There was a mean 0.29 blocks/s (95% CI 0.19 to 0.39) rehabilitation consider (i) using a group format and (ii) increase on the Box and Block Test from baseline to end the timing of sessions. of intervention. There was a mean 0.20 pegs/s (95% CI Adults undergoing inpatient rehabilitation were able 0.10 to 0.30) increase on the Nine-Hole Peg Test from to undertake a mean of 57 min of extra upper limb Table 2 Acceptability of the extra rehabilitation Acceptability (n = 20) Would you recommend this program to a friend who had suffered a 19 (95) stroke and couldn’t move their arm normally, number yes (%) On average, was the program, number yes (%): Too much practice/exercise for your arm and hand? 1 (5) Too little practice/exercise for your arm and hand? 1 (5) Just enough practice/exercise for your arm and hand? 18 (90) Did the practice make you tired, number yes (%) 8 (40) Did the practice make you so tired that you wanted to stop, number yes (%) 3 (15) How satisfied are you with the extra practice you received (0–5*), mean (SD) 4.8 (0.5) *Where 0 is ‘strongly not satisfied at all’ and 5 is ‘very satisfied’ Schneider et al. Pilot and Feasibility Studies (2019) 5:156 Page 6 of 7 Table 3 Mean (SD) for clinical outcomes at each time, mean (95% CI) difference between times and reference values for healthy adults Clinical outcome Reference Times Difference between times value Week 0 Week 4 Week 4 minus Week 0 Box and Block Test (blocks/s) 1.3 [27] 0.29 (0.25) 0.58 (0.33) 0.29 (0.19 to 0.39) Nine-Hole Peg Test (pegs/s) 1.0 [34] 0.18 (0.20) 0.37 (0.33) 0.20 (0.10 to 0.30) Grip strength (kg) 32 [38] 12 (11) 17 (11) 4 (3 to 6) practice during a mean session of 73 min, on top of a Acknowledgements Not applicable. mean of 37 min of usual upper limb rehabilitation per day. These results are comparable to the findings of the Authors’ contributions Schneider et al. [10] systematic review; 37 min of usual All authors contributed to the conception and design of the study. EJS led the study and drafted the manuscript. All authors analysed and interpreted upper limb rehabilitation per day and an extra 73 min of the data for the study, and revised the manuscript for intellectual content. extra upper limb rehabilitation per day. This equates to a All authors approved the final manuscript and are accountable for all aspects 200% increase in the amount of usual rehabilitation, only of the work. slightly less than the suggested 240% increase [10]. Fur- Funding thermore, reports of fatigue, illness, or muscle soreness NAL is supported by a Future Leaders Fellowship (Award ID: 102055) from was low (12%) and consistent with other studies in similar the National Heart Foundation of Australia. EJS received a Caulfield Hospital settings for adults after stroke [40, 41]. Research Publication Grant from Alfred Health. There are limitations to this study. First, the use of one Availability of data and materials AbleX device limited the number of adults who could The datasets used and/analyzed during the current study are available from complete the extra upper limb practice program at one the corresponding author on reasonable request. time and in some circumstances, recruitment was stopped to ensure delivery of the intervention. While the enroll- Ethics approval and consent to participate This study was conducted in accordance with Alfred Health ethics ment of 48% of the eligible participants is comparable to committee as well as La Trobe University human ethics committee that gave other studies [42], access to more than one AbleX pro- approval (ethics number 94/15). All participants gave written informed gram, or use of the GRASP program alone, may improve consent before data collection began. the recruitment of future studies. Second, the high rate of Consent for publication early discharge; participants completed the extra upper Not applicable. limb practice program for a mean of 3 weeks, delivered over a mean of 20 sessions. This suggests that future trials Competing interests The authors declare that they have no competing interest. either need to continue the program after discharge or re- duce the duration from 4 to 3 weeks. Third, while the clin- Author details ical outcomes suggest a promising improvement in upper School of Allied Health (Occupational Therapy), College of Science, Health and Engineering, La Trobe University, Plenty Road and Kingsbury Drive, limb activity and grip strength, it must be noted that all Melbourne, Victoria 3086, Australia. Occupational Therapy Department, participants had some movement at the time of recruit- Alfred Health, 55 Commercial Road, Melbourne, Victoria 3004, Australia. ment, which suggests they were capable of recovery due to Discipline of Physiotherapy, Faculty of Health Sciences, The University of Sydney, 75 East Street, Lidcombe, New South Wales 2141, Australia. having had an intact corticospinal tract [43]. Fourth, the Department of Neuroscience, Central Clinical School, Monash University, 99 use of assessors who were aware of the study aims may Commercial Road, Melbourne, Victoria 3004, Australia. have led to bias estimates of clinical outcomes. Received: 13 May 2019 Accepted: 14 November 2019 Conclusion It appears feasible for adults who are undergoing in- References patient rehabilitation and have some upper limb move- 1. Australian Institute of Health and Welfare. Stroke and its management in Australia: an update. 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Extra upper limb practice after stroke: a feasibility study

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Copyright © 2019 by The Author(s).
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Medicine & Public Health; Medicine/Public Health, general; Biomedicine, general; Statistics for Life Sciences, Medicine, Health Sciences
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2055-5784
DOI
10.1186/s40814-019-0531-5
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Abstract

Background: There is a need to provide a large amount of extra practice on top of usual rehabilitation to adults after stroke. The purpose of this study was to determine if it is feasible to add extra upper limb practice to usual inpatient rehabilitation and whether it is likely to improve upper limb activity and grip strength. Method: A prospective, single-group, pre- and post-test study was carried out. Twenty adults with upper limb activity limitations who had some movement in the upper limb completed an extra hour of upper limb practice, 6 days per week for 4 weeks. Feasibility was measured by examining recruitment, intervention (adherence, efficiency, acceptability, safety) and measurement. Clinical outcomes were upper limb activity (Box and Block Test, Nine-Hole Peg Test) and grip strength (dynamometry) measured at baseline (week 0) and end of intervention (week 4). Results: Of the 212 people who were screened, 42 (20%) were eligible and 20 (9%) were enrolled. Of the 20 participants, 12 (60%) completed the 4-week program; 7 (35%) were discharged early, and 1 (5%) withdrew. Participants attended 342 (85%) of the possible 403 sessions and practiced for 324 (95%) of the total 342 h. In terms of safety, there were no study-related adverse events. Participants increased 0.29 blocks/s (95% CI 0.19 to 0.39) on the Box and Block Test, 0.20 pegs/s (95% CI 0.10 to 0.30) on the Nine-Hole Peg Test, and 4.4 kg (95% CI 2.9 to 5.9) in grip strength, from baseline to end of intervention. Conclusions: It appears feasible for adults who are undergoing inpatient rehabilitation and have some upper limb movement after stroke to undertake an hour of extra upper limb practice. The magnitude of the clinical outcomes suggests that further investigation is warranted and this study provides useful information for the design of a phase II randomized trial. Trial registration: Australian and New Zealand Clinical Trial Registry (ACTRN12615000665538). Keywords: Rehabilitation, Occupational therapy, Physical therapy, Task-specific motor training Background control [3] and is structured to provide repetitive upper Upper limb activity is necessary for participation in activ- limb practice of specific tasks that are challenging, pro- ities of daily living [1]. More than 80% of stroke survivors gressive and skill-based [4, 5]. Yet the recovery of upper have motor impairments that can include changes to limb activity after stroke is often poor [6] and stroke survi- muscle strength as well as difficulty in controlling move- vors perceive that their time spent in upper limb rehabili- ment [2]. This decrease in muscle strength and control re- tation was not sufficient [7]. sults in a person needing assistance to complete basic There is high-level evidence that an increase in the amount daily activities [1]. Upper limb rehabilitation, therefore, of supervised rehabilitation improves motor outcome for aims to improve both muscle strength and movement stroke survivors [4, 8–10], with four systematic reviews find- ing small to moderate effect sizes [8–10]. One review investi- gated how much extra rehabilitation was required to * Correspondence: e.schneider@alfred.org.au School of Allied Health (Occupational Therapy), College of Science, Health produce a benefit and found that a 240% increase in the and Engineering, La Trobe University, Plenty Road and Kingsbury Drive, amount of usual rehabilitation was needed to ensure that the Melbourne, Victoria 3086, Australia 2 extra rehabilitation improved activity [10]. For example, if 25 Occupational Therapy Department, Alfred Health, 55 Commercial Road, Melbourne, Victoria 3004, Australia min of upper limb rehabilitation per day is usual, an extra 60 Full list of author information is available at the end of the article © The Author(s). 2019 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Schneider et al. Pilot and Feasibility Studies (2019) 5:156 Page 2 of 7 min (a total of 85 min per day) would need to be provided screened for eligibility by a researcher within 72 h of ad- to result in an improvement in upper limb activity. This is al- mission. Patients were eligible if they had a medical most three times the amount of usual rehabilitation and a diagnosis of stroke, were aged over 18 years, had an large amount of extra practice. upper limb activity limitation (defined as < 54 blocks on The challenge now is to determineafeasible waytopro- the Box and Block Test which is a 20% reduction in the vide a large amount of extra practice taking into account normal scores of adults aged 20–80 years) [27], and had staff and resource constraints. Most studies to date have de- some upper limb activity (> Grade 1 wrist extension and livered extra rehabilitation in one-on-one sessions outside > Grade 3 shoulder elevation on manual muscle testing) the usual rehabilitation service [11–21]. This model of de- in order to be able to carry out the practice [28]. Patients livery, however, is not an efficient way to increase the were excluded if they had severe cognitive and/or lan- amount of usual rehabilitation in an inpatient rehabilitation guage defects (Mini Mental Status Examination score ≤ service. The potential to provide extra rehabilitation with- 24) [29], had any medical condition that precluded them out using one-on-one supervised sessions has been ex- participating in a rehabilitation program aimed at upper plored using various strategies such as gaming, group limb activity, or had a discharge date that precluded practice or homework [22–26]. We propose to investigate them completing the 4-week program. For patients who using largely self-directed practice within inpatient rehabili- were initially ineligible (no upper limb activity), screen- tation as a way of increasing the amount of upper limb ing was repeated weekly to establish if they became eli- practice in the subacute phase after stroke. In preparation gible. Age (year), sex (number male), time since stroke for a large, fully-powered randomized trial, it is important (days), side of hemiplegia (number right), living situation to understand the feasibility of recruitment, delivering the (lives alone), education (attended university), cognition intervention and collecting the outcome measures. There- (Mini Mental Status Examination, 0–30) [29], unilateral fore, the primary questions of this study were: special neglect (Albert’s Line Cancellation Test, number of lines left uncrossed) [30], loss of light touch sensation 1. Is it feasible (in terms of recruitment, intervention and (none/some/complete), spasticity (Tardieu Scale Quality measurement) for people who are undergoing of Muscle Reaction, 0–5) [31], contracture (range of mo- inpatient rehabilitation and have some movement in tion at the wrist and elbow), complexity of rehabilitation the upper limb after stroke to undertake an extra hour needs (Rehabilitation Complexity Scale-Extended, 0–20) of upper limb practice, 6 days per week for 4 weeks? [32], and ability to pick up a cup unaided (number) and 2. Is the extra practice likely to improve upper limb walk unaided (number) were collected at baseline to de- activity and grip strength? scribe the sample. Occupational therapists overseeing the extra upper limb Method practice all had experience in neurological rehabilitation Design and were trained in task-specific motor training and the A prospective, single-group, pre- and post-test study was trial intervention prior to study commencement. One ther- conducted at a metropolitan inpatient rehabilitation hos- apist was involved in overseeing the extra upper limb prac- pital in Melbourne, Australia. The participants received tice, with incidental support from two additional therapists. extra upper limb practice for 4 weeks. Outcomes were measured at baseline (week 0) and at the end of inter- Intervention vention (week 4). The design of the study is presented in Participants undertook an extra hour of upper limb prac- Fig. 1. Outcome measures were collected by occupa- tice, 6 days a week (Monday to Saturday) for 4 weeks, con- tional therapists trained in the procedures who were not sisting of two self-directed programs designed to be used blinded to the aims of the study. University and hospital by adults with stroke: the Graded Repetitive Arm Supple- human research ethics committees approved this study. mentary Program (GRASP) and the AbleX [22, 23]. All participants gave written informed consent before GRASP is a self-directed arm and hand program that in- data collection began. corporates strengthening exercises, part practice and prac- tice of whole upper limb activities [22]. GRASP has three Setting levels of difficulty. The level of difficulty prescribed was The study was conducted in one sub-acute rehabilitation determined by participant performance on weekly clinical hospital that has > 25 beds dedicated to multidisciplinary outcome measures and ability to complete half of the tasks inpatient rehabilitation after stroke. at the maximum number of set repetitions [22]. The ther- apist provided the participant with one of six GRASP kits Participants and therapists (manual and equipment) at the start of each session. Consecutive patients admitted for inpatient rehabilita- AbleX is a computer-based upper limb program that was tion with stroke between July 2015 and June 2016 were set up by the therapist on a laptop. Participants hold a Schneider et al. Pilot and Feasibility Studies (2019) 5:156 Page 3 of 7 Fig. 1 CONSORT diagram showing the design and flow of participants through each stage of the study controller in their affected hand or bilaterally to play a complete the required amount of daily practice but could range of computer games designed to promote target- choose to practice for greater or less than 60 min per session. hitting [23]. The computer system provides participants The amount of practice and session duration was tracked with immediate feedback on their performance (accuracy), and recorded by the participant with assistance from the activity time (adherence) and exercise intensity [23]. therapist using a stopwatch and paper diary. Therapists provided direction and encouragement to prac- No other aspects of the multidisciplinary rehabilitation tice, set-up the equipment, checked the quality of the prac- were changed. The amount of usual upper limb rehabilita- tice,and progressed thedifficultyof practicetoensurethe tion that was scheduled on the participant’s timetable by the level of challenge was always high. The amount of support multidisciplinary rehabilitation team was collected. Usual was gradually reduced once the participant could follow the upper limb rehabilitation could include a combination of in- self-directed programs. To set up the equipment, the therap- dividual and group sessions provided by occupational thera- ist provided the participant with a pre-packed GRASP kit or pists and/or physiotherapists targeting task-specific motor laptop. The extra practice could be undertaken at any time training of the affected upper limb. during usual rehabilitation hours (8 a.m. to 5 p.m.), individu- ally or in a group, in the therapy area or a common space in Outcome measures the ward. The timeofthe extrapracticesession wassched- Feasibility uled on the participant’s timetable to ensure the participant The feasibility of the study involved examining recruitment, was ready for each session. Participants were encouraged to intervention (adherence, efficiency, acceptability, and safety) Schneider et al. Pilot and Feasibility Studies (2019) 5:156 Page 4 of 7 and measurement. The feasibility of recruitment was deter- Sample size mined by calculating the proportion of enrolled patients Due to the nature of a feasibility study, a formal sample from the population who were screened for eligibility. Feasi- size calculation was not performed [36]. We aimed to re- bility of the intervention was determined by examining ad- cruit 20 participants as this was considered an adequate herence (the number of sessions attended as a proportion of number to assess the feasibility [37]. the number of possible sessions), efficiency (the amount of practice as a proportion of total minutes), acceptability (par- Data analysis ticipants yes/no responses to 5 statements about the training For participant characteristics and feasibility outcomes, and rating of their acceptability from 0 to 5, Table 2), and descriptive statistics are presented as mean (SD) or safety (the number of adverse events such as fatigue, illness, number (%). For clinical outcomes, paired between-time muscle soreness, or injuries as a proportion of the number differences (week 4 minus week 0) are presented as of sessions attended). If required, an interpreter or non- mean difference (95% CI). When a participant was dis- verbal communication assisted the participant. The feasibility charged home or from the study before week 4, a meas- of measurement involved examining how many participants ure was taken at this time. could be measured for all outcomes. Results Clinical Characteristics of participants Clinical outcomes were upper limb activity and grip Twenty participants aged 63 (SD 17) years, of which 11 strength. Upper limb activity was measured using the Box (55%) were men, participated in the study. Characteris- and Block Test (number of blocks) and the Nine-Hole Peg tics of participants are presented in Table 1. Usual upper Test (s). Grip strength (kg) was measured using dyna- limb rehabilitation was scheduled for a mean of 37 (SD mometry. The Box and Block Test is a timed test of the 26) min per day with 4 (20%) participants scheduled to ability to grasp and release. The instructions for the test receive no upper limb rehabilitation. were standardized according to Mathiowetz et al. [27]. Participants were asked to pick up and move one block at Feasibility a time over a barrier to the other side of the box as quickly Recruitment as possible. The ability to grasp and release was trans- Over an 11-month period, 212 people were screened, 42 ferred to a rate of performance by dividing the number of (20%) were eligible, and 20 (9%) were enrolled. In terms blocks moved by 60 s (number of blocks/s). of retention, at week 4, 7 (35%) participants had already The Nine-Hole Peg Test is a timed test of the ability been discharged home and one (5%) had withdrawn (co- to grasp, manipulate and place small objects with one enrolled in another study and reported fatigue). Partici- hand. The instructions for the test were modified to in- pants completed the extra upper limb practice program corporate additional stopping points [33, 34]. Partici- for a mean of 3 (SD 1) weeks. The flow of participants pants were asked to pick up the 9 pegs one at a time through the study is presented in Fig. 1. and place them in the holes until all nine holes were filled; then remove the 9 pegs one at a time and return them to the tray. The participants were told not to con- Intervention tinue the test if they had placed zero pegs into the holes Removing the 77 sessions missed due to early discharge of at 60 s [33]. The participants were told not to continue seven participants from the study, there were a possible the test if they had not completed the test (placed and 403 sessions. Adherence to the intervention was 85% (i.e., removed all 9 pegs) in 120 s [34]. The number of pegs 342 out of a possible 403 sessions). Forty-five (11%) ses- moved was quantified as 0–18 pegs; either 0–9 pegs sions were missed because of non-attendance (illness, fa- placed into the holes or 10–18 pegs returned to the tray. tigue, visitors); and 15 (4%) sessions were missed because The score was then transferred to a rate of performance the participant withdrew. Efficiency of the intervention by dividing the number of pegs moved by the number of was 95%; i.e., participants completed 324 h of practice seconds to complete or stop the test (pegs/s). during a total of 342 h. Participants undertook a mean of Dynamometry of maximum voluntary contraction of 57 (SD 9) min of extra upper limb practice during a mean grip measures the strength of muscles in the forearm session of 73 (SD 10) min. Acceptability of the interven- and hand. The instructions for the test were standard- tion is presented in Table 2. Overall, the participants were ized according to Horowitz [35]. Grip strength was satisfied (4.8 out of 5.0) with their extra practice. In terms quantified by the number of kilograms achieved. If the of safety, the incidence of fatigue, illness, or muscle sore- participant could register some strength but not enough ness during the 342 intervention sessions was 40 (12%); 32 to reach the first increment on the dynamometer (at 2 (9%) reports of fatigue; 4 (1%) reports of illness; 4 (1%) re- kg), the score was recorded as 1 kg. ports of localized muscle soreness in the affected arm. Schneider et al. Pilot and Feasibility Studies (2019) 5:156 Page 5 of 7 Table 1 Baseline characteristics of participants baseline to end of intervention. There was a mean 4.4 kg (95% CI 2.9 to 5.9) increase in grip strength from base- Characteristic (n = 20) line to end of intervention. Age (year), mean (SD) 63 (17) Sex, n male (%) 11 (55) Discussion Time since stroke (day), mean (SD) 38 (87) This study demonstrates that it appears feasible for people Side of hemiplegia, n right (%) 12 (60) who are undergoing inpatient rehabilitation and have Living situation, n lives alone (%) 9 (45) some movement in the upper limb after stroke to under- Education, n attended university (%) 9 (45) take an extra hour of upper limb practice, 6 days per week until discharge or for up to 4 weeks. Participants attended Cognition (MMSE, 0–30), mean (SD) 28 (2) the majority of sessions, practiced for the majority of ses- Neglect (Albert’s Line Cancelation Test), n (%) 2 (10) sion duration, rated the acceptability of the intervention as Loss of light touch sensation, n (%) high, and reported a low number of adverse events during None 18 (90) the extra upper limb practice. The change observed in the Some 2 (10) clinical outcomes suggests a promising improvement in Complete 0 (0) upper limb activity and grip strength above what might normally be expected [39]. For example, it has been sug- Spasticity (Tardieu Scale Quality of Muscle Reaction, 0–5), mean (SD) gested that time alone accounts for 16% improvement in Wrist flexors 0.15 (0.38) impairments over 6–10 weeks [39]compared with our Biceps 0.2 (0.51) 42% improvement in grip strength and 100% improve- Contracture upper limb, n (%) 3 (15) ment in upper limb activity over 4 weeks. Complexity of rehabilitation needs (RCS, 0–20), mean (SD) 12 (2) This study provided evidence that extra practice was Grasps unaided, n (%) 10 (50) feasible; however, this was not provided within the usual resources provided within the inpatient rehabilitation unit. Walks unaided, n (%) 2 (10) The participants were often unavailable during usual MMSE Mini-Mental Status Exam, RCS Rehabilitation Complexity Scale-Extended working hours, either completing usual daily activities There were no injuries or serious adverse events (study re- (shower, dress, eat), engaged in usual rehabilitation, rest- lated or otherwise). ing, or with family/visitors. Therefore, the extra upper limb practice was often undertaken after usual rehabilita- Measurement tion and before dinner (4.30–5.30 p.m.) and within the Clinical outcomes were collected from all 20 (100%) par- common space in the ward to reduce transportation and ticipants at week 4 or prior to discharge home or where nursing staff could ensure the safety of the partici- withdrawal. pants during self-directed practice. Seventy-two percent of the self-directed practice was undertaken in a group in the Clinical ward. We recommend that future trials designed to deliver The group clinical outcomes are presented in Table 3. extra upper limb practice to adults undergoing inpatient There was a mean 0.29 blocks/s (95% CI 0.19 to 0.39) rehabilitation consider (i) using a group format and (ii) increase on the Box and Block Test from baseline to end the timing of sessions. of intervention. There was a mean 0.20 pegs/s (95% CI Adults undergoing inpatient rehabilitation were able 0.10 to 0.30) increase on the Nine-Hole Peg Test from to undertake a mean of 57 min of extra upper limb Table 2 Acceptability of the extra rehabilitation Acceptability (n = 20) Would you recommend this program to a friend who had suffered a 19 (95) stroke and couldn’t move their arm normally, number yes (%) On average, was the program, number yes (%): Too much practice/exercise for your arm and hand? 1 (5) Too little practice/exercise for your arm and hand? 1 (5) Just enough practice/exercise for your arm and hand? 18 (90) Did the practice make you tired, number yes (%) 8 (40) Did the practice make you so tired that you wanted to stop, number yes (%) 3 (15) How satisfied are you with the extra practice you received (0–5*), mean (SD) 4.8 (0.5) *Where 0 is ‘strongly not satisfied at all’ and 5 is ‘very satisfied’ Schneider et al. Pilot and Feasibility Studies (2019) 5:156 Page 6 of 7 Table 3 Mean (SD) for clinical outcomes at each time, mean (95% CI) difference between times and reference values for healthy adults Clinical outcome Reference Times Difference between times value Week 0 Week 4 Week 4 minus Week 0 Box and Block Test (blocks/s) 1.3 [27] 0.29 (0.25) 0.58 (0.33) 0.29 (0.19 to 0.39) Nine-Hole Peg Test (pegs/s) 1.0 [34] 0.18 (0.20) 0.37 (0.33) 0.20 (0.10 to 0.30) Grip strength (kg) 32 [38] 12 (11) 17 (11) 4 (3 to 6) practice during a mean session of 73 min, on top of a Acknowledgements Not applicable. mean of 37 min of usual upper limb rehabilitation per day. These results are comparable to the findings of the Authors’ contributions Schneider et al. [10] systematic review; 37 min of usual All authors contributed to the conception and design of the study. EJS led the study and drafted the manuscript. All authors analysed and interpreted upper limb rehabilitation per day and an extra 73 min of the data for the study, and revised the manuscript for intellectual content. extra upper limb rehabilitation per day. This equates to a All authors approved the final manuscript and are accountable for all aspects 200% increase in the amount of usual rehabilitation, only of the work. slightly less than the suggested 240% increase [10]. Fur- Funding thermore, reports of fatigue, illness, or muscle soreness NAL is supported by a Future Leaders Fellowship (Award ID: 102055) from was low (12%) and consistent with other studies in similar the National Heart Foundation of Australia. EJS received a Caulfield Hospital settings for adults after stroke [40, 41]. Research Publication Grant from Alfred Health. There are limitations to this study. First, the use of one Availability of data and materials AbleX device limited the number of adults who could The datasets used and/analyzed during the current study are available from complete the extra upper limb practice program at one the corresponding author on reasonable request. time and in some circumstances, recruitment was stopped to ensure delivery of the intervention. While the enroll- Ethics approval and consent to participate This study was conducted in accordance with Alfred Health ethics ment of 48% of the eligible participants is comparable to committee as well as La Trobe University human ethics committee that gave other studies [42], access to more than one AbleX pro- approval (ethics number 94/15). All participants gave written informed gram, or use of the GRASP program alone, may improve consent before data collection began. the recruitment of future studies. Second, the high rate of Consent for publication early discharge; participants completed the extra upper Not applicable. limb practice program for a mean of 3 weeks, delivered over a mean of 20 sessions. This suggests that future trials Competing interests The authors declare that they have no competing interest. either need to continue the program after discharge or re- duce the duration from 4 to 3 weeks. Third, while the clin- Author details ical outcomes suggest a promising improvement in upper School of Allied Health (Occupational Therapy), College of Science, Health and Engineering, La Trobe University, Plenty Road and Kingsbury Drive, limb activity and grip strength, it must be noted that all Melbourne, Victoria 3086, Australia. Occupational Therapy Department, participants had some movement at the time of recruit- Alfred Health, 55 Commercial Road, Melbourne, Victoria 3004, Australia. ment, which suggests they were capable of recovery due to Discipline of Physiotherapy, Faculty of Health Sciences, The University of Sydney, 75 East Street, Lidcombe, New South Wales 2141, Australia. having had an intact corticospinal tract [43]. Fourth, the Department of Neuroscience, Central Clinical School, Monash University, 99 use of assessors who were aware of the study aims may Commercial Road, Melbourne, Victoria 3004, Australia. have led to bias estimates of clinical outcomes. Received: 13 May 2019 Accepted: 14 November 2019 Conclusion It appears feasible for adults who are undergoing in- References patient rehabilitation and have some upper limb move- 1. Australian Institute of Health and Welfare. Stroke and its management in Australia: an update. 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Pilot and Feasibility StudiesSpringer Journals

Published: Dec 30, 2019

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