Frederike van Wijck

Botulinum Toxin for the Upper Limb After Stroke (BoTULS) Trial Effect on Impairment, Activity Limitation, and Pain

Background and Purpose— Botulinum toxin is increasingly used to treat upper limb spasticity due to stroke, but its impact on arm function is unclear. We evaluated botulinum toxin for upper limb spasticity and function poststroke. Methods— Three hundred thirty-three patients with stroke with upper limb spasticity and reduced arm function participated in a multicenter randomized controlled trial. The intervention group received botulinum toxin type A injection(s) plus a 4-week therapy program. The control group received the therapy program alone. Repeat injection(s) and therapy were available at 3, 6, and 9 months. The primary outcome was upper limb function at 1 month (Action Research Arm Test). Secondary outcomes included measures of impairment, activity limitation, and pain at 1, 3, and 12 months. Outcome assessments were blinded and analysis was by intention to treat. Results— There was no significant difference in achievement of improved arm function (Action Research Arm Test) at 1 month (intervention group: 42 of 167 [25.1%], control group 30 of 154 [19.5%]; P=0.232). Significant differences in favor of the intervention group were seen in muscle tone at 1 month; upper limb strength at 3 months; basic arm functional tasks (hand hygiene, facilitation of dressing) at 1, 3, and 12 months; and pain at 12 months. Conclusions— Botulinum toxin type A is unlikely to be useful for improving active upper limb function (eg, reaching and grasping) in the majority of patients with spasticity after stroke, but it may improve basic upper limb tasks (hand hygiene, facilitation of dressing) and pain.

The effects and experiences of goal setting in stroke rehabilitation - a systematic review.

Objective: To systematically integrate and appraise the evidence for effects and experiences of goal setting in stroke rehabilitation. Design: Systematic review of quantitative and qualitative studies. Methods: Relevant databases were searched from start of database to 30 April 2011. Studies of any design employing goal setting, reporting stroke-specific data and evaluating its effects and/ or experiences were included. Results: From a total of 53998 hits, 112 full texts were analysed and 17 studies were included, of which seven evaluated effects while ten explored experiences of goal setting. No eligible randomized controlled trials were identified. Most of the included studies had weak to moderate methodological strengths. The design, methods of goal setting and outcome measures differed, making pooling of results difficult. Goal setting appeared to improve recovery, performance and goal achievement, and positively influenced patients’ perceptions of self-care ability and engagement in rehabilitation. However, the actual extent of patient involvement in the goal setting process was not made clear. Patients were often unclear about their role in this process. Professionals reported higher levels of collaboration during goal setting than patients. Patients and professionals differed on how they set goals, types of goals set, and on how they perceived goal attainment. Barriers to goal setting outnumbered the facilitators. Conclusion: Due to the heterogeneity and quality of included studies, no firm conclusions could be made on the effectiveness, feasibility and acceptability of goal setting in stroke rehabilitation. Further rigorous research is required to strengthen the evidence base. Better collaboration and communication between patients and professionals and relevant education are recommended for best practice. Implications for Rehabilitation Communication is key to collaborative goal setting. Education and training of professionals regarding goal setting is recommended, especially in relation to methods of involving people with communication and cognitive impairments. Educating patients about stroke and goal setting could enhance their participation in goal setting.

A Comparison of Bilateral and Unilateral Upper-Limb Task Training in Early Poststroke Rehabilitation: A Randomized Controlled Trial

OBJECTIVE To compare the effects of bilateral task training with unilateral task training on upper-limb outcomes in early poststroke rehabilitation. DESIGN A single-blinded randomized controlled trial, with outcome assessments at baseline, postintervention (6 wk), and follow-up (18 wk). SETTING Inpatient acute and rehabilitation hospitals. PARTICIPANTS Patients were randomized to receive bilateral training (n=56) or unilateral training (n=50) at 2 to 4 weeks poststroke onset. INTERVENTION Supervised bilateral or unilateral training for 20 minutes on weekdays over 6 weeks using a standardized program. MAIN OUTCOME MEASURES Upper-limb outcomes were assessed by Action Research Arm Test (ARAT), Rivermead Motor Assessment upper-limb scale, and Nine-Hole Peg Test (9HPT). Secondary measures included the Modified Barthel Index, Hospital Anxiety and Depression Scale, and Nottingham Health Profile. All assessment was conducted by a blinded assessor. RESULTS No significant differences were found in short-term improvement (0-6 wk) on any measure (P>.05). For overall improvement (0-18 wk), the only significant between-group difference was a change in the 9HPT (95% confidence interval [CI], 0.0-0.1; P=.05) and ARAT pinch section (95% CI, 0.3-5.6; P=.03), which was lower for the bilateral training group. Baseline severity significantly influenced improvement in all upper-limb outcomes (P<.05), but this was irrespective of the treatment group. CONCLUSIONS Bilateral training was no more effective than unilateral training, and in terms of overall improvement in dexterity, the bilateral training group improved significantly less. Intervention timing, task characteristics, dose, and intensity of training may have influenced the results and are therefore areas for future investigation.

Assessing Motor Deficits in Neurological Rehabilitation: Patterns of Instrument Usage

To describe current patterns in the use of clinical scales and measurement tech nology for the assessment of motor deficits in neurological rehabilitation. Question naire, sent to the 2,556 members of the World Forum for Neurological Rehabilita tion, distributed over 75 countries. Sixty-eight questionnaires were returned. Generally, participants indicated that the centres where they were based used a num ber of different clinical assessment scales (median, three), most frequently with a small proportion of patients. The (Modified) Ashworth Scale, the FIM, and the Fugl-Meyer were used most frequently. Only 35 respondents stated that their centre used one or more scales in >75% of their patients, but the choice of such routinely applied in struments varied between centres. The application of measurement technology was re stricted, with video and goniometry being used most frequently. The main barriers to more frequent use of assessment tools were perceived to be a lack of resources, infor mation, and training. The (albeit limited) results from this survey suggest that the assessment of motor deficits in neurological rehabilitation is currently mostly qualita tive and lacks standardisation. More resources and education are required to support a more routine application of assessment tools and to integrate measurement tech nology further in neurological rehabilitation to assist in the process of quantification of outcomes. Key Words: Motor deficits—Neurological rehabilitation—Outcome as sessment—Standardisation—Measurement technology.

Predicting health related quality of life 6 months after stroke: the role of anxiety and upper limb dysfunction

Purpose: This study examined the role of anxiety and upper limb dysfunction, amongst other variables, as predictors of health related quality of life (HRQOL) 6 months after stroke. Method: Participants: Stroke survivors (n = 85) who had previously participated in a randomised controlled trial of a physiotherapy intervention. Dependent variable: HRQOL – Nottingham Health Profile (NHP). Predictor variables: Mood – Hospital Depression and Anxiety Scale; Upper Limb Functioning - Action Research Arm Test; Rivermead Motor Assessment; Activities of Daily Living – Modified Barthel Index; Clinical and demographic factors. Results: Anxiety and depression significantly predicted 49% of variance in overall HRQOL (p < 0.05), but only anxiety significantly predicted NHP pain (13% variance, p < 0.001), emotional reactions (41% variance, p < 0.001), sleep (19% variance, p = 0.02) and social isolation (23% variance, p = 0.02). Depression and anxiety together significantly predicted 30% variance in energy level (p < 0.001). UL motor impairment and activities of daily living predicted 36% of variance in NHP physical activity score (p < 0.001). Conclusions: This study indicates that where anxiety is assessed, it appears more important in determining HRQOL than depression. UL impairment and ADL independence predicted perceived physical activity. Management strategies for anxiety and therapy for UL recovery long after stroke onset are likely to benefit perceived HRQOL. Implications for Rehabilitation Anxiety is a major predictor of quality of life six months after stroke. Post-stroke anxiety should be routinely assessed in rehabilitation. Appropriate management strategies for anxiety should occur during rehabilitation with follow-up into the chronic post-stroke period. Upper limb impairment is a stronger predictor of perceptions of physical activity than independence in activities daily living six months after stroke. Rehabilitation of the upper limb should continue into the chronic post-stroke period.

A qualitative theory guided analysis of stroke survivors’ perceived barriers and facilitators to physical activity

Abstract Purpose: After stroke, physical activity and physical fitness levels are low, impacting on health, activity and participation. It is unclear how best to support stroke survivors to increase physical activity. Little is known about the barriers and facilitators to physical activity after stroke. Thus, our aim was to explore stroke survivors’ perceived barriers and facilitators to physical activity. Methods: Semi-structured interviews with 13 ambulatory stroke survivors exploring perceived barriers and facilitators to physical activity post stroke were conducted in participants’ homes, audio-recorded and transcribed verbatim. The Theoretical Domains Framework (TDF) informed content analysis of the interview transcripts. Results: Data saturation was reached after interviews with 13 participants (median age of 76 years (inter-quartile range (IQR) = 69–83 years). The median time since stroke was 345 d (IQR = 316–366 d). The most commonly reported TDF domains were “beliefs about capabilities”, “environmental context and resources” and “social influence”. The most commonly reported perceived motivators were: social interaction, beliefs of benefits of exercise, high self-efficacy and the necessity of routine behaviours. The most commonly reported perceived barriers were: lack of professional support on discharge from hospital and follow-up, transport issues to structured classes/interventions, lack of control and negative affect. Conclusions: Stroke survivors perceive several different barriers and facilitators to physical activity. Stroke services need to address barriers to physical activity and to build on facilitators to promote physical activity after stroke. Implications for Rehabilitation Physical activity post stroke can improve physical fitness and function, yet physical activity remains low among stroke survivors. Understanding stroke survivors’ perceived barriers and facilitators to physical activity is essential to develop targeted interventions to increase physical activity. Beliefs about capabilities, environmental context and resources and social influences were the mostly commonly report influences on stroke survivors’ perceived barriers and facilitators to physical activity.

The construct validity of a spasticity measurement device for clinical practice: An alternative to the Ashworth scales

Introduction. Spasticity is a significant cause of disability in people with an upper motor neurone lesion, but there is a paucity of appropriate outcome measures to evaluate this phenomenon. The aim was to test the construct validity of a clinically relevant, non-invasive measure of spasticity. Methods. A cross-section study design in which participants with elbow flexor spasticity and capable of providing written informed consent were recruited. Results. Fourteen stroke patients participated (six female and eight male). Median age was 61 years and the median time post stroke was 48 months. Six patients had a MAS grading of ‘1+’, three a grade of ‘2’ and five a grade of ‘3’. The velocity of the brisk stretch was significantly higher than that of the slow stretch (p < 0.05: median difference, 34°/s: IQR, 20 – 46). Flexor muscle activity during the brisk stretch was significantly higher than that of the slow stretch (p < 0.05: median difference, 2.0 μV; IQR, 0.4 – 8.4). In contrast the RPE was not significantly different between the slow and the fast stretches (p > 0.1: median difference, 0.07 N/deg; IQR, – 0.09 – 0.16). There were no patterns of association between the MAS, elbow flexor muscle activity and RPE. Other important observations, in some patients, were: continuous background muscle activation consistent with descriptions of spastic dystonia; muscle activity at the slow velocity stretch; muscle activation patterns consistent with the clasp-knife phenomenon. Conclusions. The measurement system was capable of measuring spasticity as defined by Lance (2; In: Lance et al., editors. Spasticity: disordered motor control. Chicago, IL: Year Book. p 185 – 204). In addition, it enabled various other clinical phenomena associated with spasticity to be measured. Assessing spasticity by measuring changes in resistance to passive movement only may not be sufficient, as the latter is influenced by many factors of which spasticity may only be one. Further work is now required to investigate repeatability and sensitivity.

Augmented visual feedback of movement performance to enhance walking recovery after stroke: study protocol for a pilot randomised controlled trial

BackgroundIncreasing evidence suggests that use of augmented visual feedback could be a useful approach to stroke rehabilitation. In current clinical practice, visual feedback of movement performance is often limited to the use of mirrors or video. However, neither approach is optimal since cognitive and self-image issues can distract or distress patients and their movement can be obscured by clothing or limited viewpoints. Three-dimensional motion capture has the potential to provide accurate kinematic data required for objective assessment and feedback in the clinical environment. However, such data are currently presented in numerical or graphical format, which is often impractical in a clinical setting. Our hypothesis is that presenting this kinematic data using bespoke visualisation software, which is tailored for gait rehabilitation after stroke, will provide a means whereby feedback of movement performance can be communicated in a more meaningful way to patients. This will result in increased patient understanding of their rehabilitation and will enable progress to be tracked in a more accessible way.MethodsThe hypothesis will be assessed using an exploratory (phase II) randomised controlled trial. Stroke survivors eligible for this trial will be in the subacute stage of stroke and have impaired walking ability (Functional Ambulation Classification of 1 or more). Participants (n = 45) will be randomised into three groups to compare the use of the visualisation software during overground physical therapy gait training against an intensity-matched and attention-matched placebo group and a usual care control group. The primary outcome measure will be walking speed. Secondary measures will be Functional Ambulation Category, Timed Up and Go, Rivermead Visual Gait Assessment, Stroke Impact Scale-16 and spatiotemporal parameters associated with walking. Additional qualitative measures will be used to assess the participant’s experience of the visual feedback provided in the study.DiscussionResults from the trial will explore whether the early provision of visual feedback of biomechanical movement performance during gait rehabilitation demonstrates improved mobility outcomes after stroke and increased patient understanding of their rehabilitation.Trial registrationCurrent Controlled Trials ISRCTN79005974

Home-based reach-to-grasp training for people after stroke: study protocol for a feasibility randomized controlled trial

BackgroundThis feasibility study is intended to assess the acceptability of home-based task-specific reach-to-grasp (RTG) training for people with stroke, and to gather data to inform recruitment, retention, and sample size for a definitive randomized controlled trial.Methods/designThis is to be a randomized controlled feasibility trial recruiting 50 individuals with upper-limb motor impairment after stroke. Participants will be recruited after discharge from hospital and up to 12 months post-stroke from hospital stroke services and community therapy-provider services. Participants will be assessed at baseline, and then electronically randomized and allocated to group by minimization, based on the time post-stroke and extent of upper-limb impairment. The intervention group will receive 14 training sessions, each 1 hour long, with a physiotherapist over 6 weeks and will be encouraged to practice independently for 1 hour/day to give a total of 56 hours of training time per participant. Participants allocated to the control group will receive arm therapy in accordance with usual care. Participants will be measured at 7 weeks post-randomization, and followed-up at 3 and 6 months post-randomization. Primary outcome measures for assessment of arm function are the Action Research Arm Test (ARAT) and Wolf Motor Function Test (WMFT). Secondary measures are the Motor Activity Log, Stroke Impact Scale, Carer Strain Index, and health and social care resource use. All assessments will be conducted by a trained assessor blinded to treatment allocation. Recruitment, adherence, withdrawals, adverse events (AEs), and completeness of data will be recorded and reported.DiscussionThis study will determine the acceptability of the intervention, the characteristics of the population recruited, recruitment and retention rates, descriptive statistics of outcomes, and incidence of AEs. It will provide the information needed for planning a definitive trial to test home-based RTG training.Trial registrationISRCTN: ISRCTN56716589

Study design and methods of the BoTULS trial: a randomised controlled trial to evaluate the clinical effect and cost effectiveness of treating upper limb spasticity due to stroke with botulinum toxin type A

BackgroundFollowing a stroke, 55–75% of patients experience upper limb problems in the longer term. Upper limb spasticity may cause pain, deformity and reduced function, affecting mood and independence. Botulinum toxin is used increasingly to treat focal spasticity, but its impact on upper limb function after stroke is unclear.The aim of this study is to evaluate the clinical and cost effectiveness of botulinum toxin type A plus an upper limb therapy programme in the treatment of post stroke upper limb spasticity.MethodsTrial design : A multi-centre open label parallel group randomised controlled trial and economic evaluation.Participants : Adults with upper limb spasticity at the shoulder, elbow, wrist or hand and reduced upper limb function due to stroke more than 1 month previously.Interventions : Botulinum toxin type A plus upper limb therapy (intervention group) or upper limb therapy alone (control group).Outcomes : Outcome assessments are undertaken at 1, 3 and 12 months. The primary outcome is upper limb function one month after study entry measured by the Action Research Arm Test (ARAT). Secondary outcomes include: spasticity (Modified Ashworth Scale); grip strength; dexterity (Nine Hole Peg Test); disability (Barthel Activities of Daily Living Index); quality of life (Stroke Impact Scale, Euroqol EQ-5D) and attainment of patient-selected goals (Canadian Occupational Performance Measure). Health and social services resource use, adverse events, use of other antispasticity treatments and patient views on the treatment will be compared. Participants are clinically reassessed at 3, 6 and 9 months to determine the need for repeat botulinum toxin type A and/or therapy.Randomisation : A web based central independent randomisation service.Blinding : Outcome assessments are undertaken by an assessor who is blinded to the randomisation group.Sample size : 332 participants provide 80% power to detect a 15% difference in treatment successes between intervention and control groups. Treatment success is defined as improvement of 3 points for those with a baseline ARAT of 0–3 and 6 points for those with ARAT of 4–56.Trial registrationISRCTN78533119EudraCT 2004-002427-40CTA 17136/0230/001FundingNational Institute for Health Research, Health Technology Assessment Programme.Ipsen Ltd provide botulinum toxin type A (Dysport®).