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Dynamic Lycra® orthoses as an adjunct to arm rehabilitation after stroke: a single-blind, two-arm parallel group, randomized controlled feasibility trial.

ABSTRACT: OBJECTIVE:The aim of this study was to explore the feasibility of conducting a randomized controlled trial of dynamic Lycra® orthoses as an adjunct to arm rehabilitation after stroke and to explore the magnitude and direction of change on arm outcomes. DESIGN:This is a single-blind, two-arm parallel group, feasibility randomized controlled trial. SETTING:In-patient rehabilitation. SUBJECTS:The study participants were stroke survivors with arm hemiparesis two to four?weeks after stroke receiving in-patient rehabilitation. INTERVENTIONS:Participants were randomized 2:1 to wear Lycra® gauntlets for eight hours daily for eight?weeks, plus usual rehabilitation (n?=?27), or to usual rehabilitation only (n?=?16). MAIN MEASURES:Recruitment, retention, fidelity, adverse events and completeness of data collection were examined at 8 and 16?weeks; arm function (activity limitation; Action Research Arm Test, Motor Activity Log) and impairment (Nine-hole Peg Test, Motricity Index, Modified Tardieu Scale). Structured interviews explored acceptability. RESULTS:Of the target of 51, 43 (84%) participants were recruited. Retention at 8?weeks was 32 (79%) and 24 (56%) at 16?weeks. In total, 11 (52%) intervention group participants and 6 (50%) control group participants (odds ratio = 1.3, 95% confidence interval = 0.2 to 7.8) had improved Action Research Arm Test level by 8?weeks; at 16?weeks, this was 8 (61%) intervention and 6 (75.0%) control participants (odds ratio = 1.1, 95% confidence interval = 0.1 to 13.1). Change on other measures favoured control participants. Acceptability was influenced by 26 adverse reactions. CONCLUSION:Recruitment and retention were low, and adverse reactions were problematic. There were no indications of clinically relevant effects, but the small sample means definitive conclusions cannot be made. A definitive trial is not warranted without orthoses adaptation.

SUBMITTER: Morris JH

PROVIDER: S-EPMC6613174 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

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Dynamic Lycra® orthoses as an adjunct to arm rehabilitation after stroke: a single-blind, two-arm parallel group, randomized controlled feasibility trial.

Morris Jacqui H JH John Alexandra A Wedderburn Lucy L Rauchhaus Petra P Donnan Peter T PT

Clinical rehabilitation 20190412 8

<h4>Objective</h4>The aim of this study was to explore the feasibility of conducting a randomized controlled trial of dynamic Lycra<sup>®</sup> orthoses as an adjunct to arm rehabilitation after stroke and to explore the magnitude and direction of change on arm outcomes.<h4>Design</h4>This is a single-blind, two-arm parallel group, feasibility randomized controlled trial.<h4>Setting</h4>In-patient rehabilitation.<h4>Subjects</h4>The study participants were stroke survivors with arm hemiparesis t ...[more]

PMID: 30977382

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Project description:BackgroundVirtual reality training (VRT) uses computer software to track a user's movements and allow him or her to interact with a game presented on a television screen. VRT is increasingly being used for the rehabilitation of arm function, balance and walking after stroke. Patients often require ongoing therapy post discharge from inpatient rehabilitation. Outpatient therapy may be limited or inaccessible due to waiting lists, transportation issues, distance etc.; therefore, home-based VRT could provide the required therapy in a more convenient and accessible setting. The objectives of this parallel randomized feasibility trial are to determine (1) the feasibility of using VRT in the home post stroke and (2) the feasibility of a battery of quantitative and qualitative outcome measures of stroke recovery.MethodsForty patients who can stand for at least 2 min and are soon to be discharged from inpatient or outpatient rehabilitation post stroke are being recruited in Ottawa, Canada and being randomized to control and experimental groups. Participants in the experimental group use home-based VRT to do rehabilitative exercises for standing balance, stepping, reaching, strengthening and gentle aerobic fitness. Control group participants use an iPad with apps selected to rehabilitate cognition, hand fine motor skills and visual tracking/scanning. Both groups are instructed to perform 30 min of exercise 5 days a week for 6 weeks. VRT intensity and difficulty are monitored and adjusted remotely. Weekly telephone contact is made with all participants. Ability to recruit participants, ability to handle the technology and learn the activities, compliance, safety, enjoyment, perceived efficacy and cost of program delivery will be assessed. A battery of assessments of standing balance, gait and community integration will be assessed for feasibility of completion within this population and potential for improvement following the intervention. Effect sizes will be calculated.DiscussionThe results of this study will be used to support the creation of a definitive randomized controlled trial on the efficacy of home-based VRT for rehabilitation post stroke.Trial registrationClinicalTrials.gov, NCT03261713 . Registered on 21 August 2017. Registration amended on 1 June 2018 to decrease enrollment from 40 to 20 due to a cut in study funding and difficulty recruiting participants.

Project description:Neurologic music therapy in rehabilitation of stroke patients has been shown to be a promising supplement to the often strenuous conventional rehabilitation strategies. The aim of this study was threefold: (i) replicate results from a previous study with a sample from one clinic (henceforth called Site 1; N = 12) using an already established recording system, and (ii) conceptually replicate previous findings with a less costly hand-tracking system in Site 2 (N = 30), and (iii) compare both sub-studies' outcomes to estimate the efficiency of neurologic music therapy. Stroke patients in both sites were randomly assigned to treatment or control groups and received daily training of guided sequential upper limb movements additional to their standard stroke rehabilitation protocol. Treatment groups received sonification (i.e., changes in musical pitch) of their movements when they moved their affected hand up and down to reproduce a sequence of the first six notes of a C major scale. Controls received the same movement protocol, however, without auditory feedback. Sensors at the upper arm and the forearm (Xsens) or an optic sensor device (Leapmotion) allowed to measure kinematics of movements and movement smoothness. Behavioral measures pre and post intervention included the Fugl-Meyer assessment (FMA) and the Stroke Impact Scale (SIS) and movement data. Bayesian regression did not show evidence supporting an additional effect of sonification on clinical mobility assessments. However, combined movement data from both sites showed slight improvements in movement smoothness for the treatment group, and an advantage for one of the two motion capturing systems. Exploratory analyses of EEG-EMG phase coherence during movement of the paretic arm in a subset of patients suggested increases in cortico-muscular phase coherence specifically in the ipsilesional hemisphere after sonification therapy, but not after standard rehabilitation therapy. Our findings show that musical sonification is a viable treatment supplement to current neurorehabilitation methods, with limited clinical benefits. However, given patients' enthusiasm during training and the low hardware price of one of the systems it may be considered as an add-on home-based neurorehabilitation therapy.

Project description:ObjectivesArm weakness is common after stroke; repetitive activity is critical for recovery but people struggle with knowing what to do, volume, and monitoring progress. We studied the feasibility and acceptability of OnTrack, a digital intervention supporting arm and hand rehabilitation in acute and home settings.DesignA mixed-method, single-arm study evaluating the feasibility of OnTrack for hospital and home use. An independent process evaluation assessed the intervention's fidelity, dose and reach. Amendments to the protocol were necessary after COVID-19.SettingAcute stroke services and home settings in North West London.Participants12 adults with a stroke diagnosis <6 months previously (first or recurrent) requiring arm rehabilitation in hospital and/or home.Intervention12 weeks using the OnTrack system comprising arm tracking and coaching support for self-management.Primary and secondary outcome measuresRecruitment, retention and completion rates; compliance and adherence to the intervention; reasons for study decline/withdrawal.Intervention fidelity and acceptability, evaluated through an independent process evaluation.Patient measures including activity baseline, healthcare activation, arm function and impairment collected at baseline, week 7 and week 14 of participation to assess suitability for a randomised controlled trial (RCT).Results181 individuals screened, 37 met eligibility criteria, 24 recruited (65%); of these, 15 (63%) were recruited before COVID-19, and 9 (37%) during. 12 completed the intervention (50%). Despite COVID-19 disruptions, recruitment, retention and completion were in line with prestudy expectations and acceptable for a definitive trial. Participants felt the study requirements were acceptable and the intervention usable. Fidelity of delivery was acceptable according to predetermined fidelity markers. Outcome measures collected helped determine sample size estimates and primary outcomes for an RCT.ConclusionsThe intervention was found to be usable and acceptable by participants; study feasibility objectives were met and demonstrated that a definitive RCT would be viable and acceptable.Trial registration numberNCT03944486.

Project description:Objective: It was the aim to assess feasibility, safety, and potential efficacy of a new intensive, focused arm-hand BOOST program and to investigate whether there is a difference between early vs. late delivery of the program in the sub-acute phase post stroke. Methods: In this pilot RCT, patients with stroke were randomized to the immediate group (IG): 4 weeks (4 w) BOOST +4 w CONTROL or the delayed group (DG): 4 w CONTROL +4 w BOOST, on top of their usual inpatient care program. The focused arm-hand BOOST program (1 h/day, 5x/week, 4 weeks) consisted of group exercises with focus on scapula-setting, core-stability, manipulation and complex ADL tasks. Additionally, 1 h per week the Armeo®Power (Hocoma AG, Switzerland) was used. The CONTROL intervention comprised a dose-matched program (24 one-hour sessions in 4 w) of lower limb strengthening exercises and general reconditioning. At baseline, after 4 and 8 weeks of training, the Fugl-Meyer assessment upper extremity (FMA-UE), action research arm test (ARAT), and stroke upper limb capacity scale (SULCS) were administered. Results: Eighteen participants (IG: n = 10, DG: n = 8) were included, with a median (IQR) time post stroke of 8.6 weeks (5-12). No adverse events were experienced. After 4 weeks of training, significant between-group differences were found for FMA-UE (p = 0.003) and SULCS (p = 0.033) and a trend for ARAT (p = 0.075) with median (IQR) change scores for the IG of 9 (7-16), 2 (1-3), and 12.5 (1-18), respectively, and for the DG of 0.5 (-3 to 3), 1 (0-1), and 1.5 (-1 to 9), respectively. In the IG, 80% of patients improved beyond the minimal clinical important difference of FMA-UE after 4 weeks, compared to none of the DG patients. Between 4 and 8 weeks of training, patients in the DG tend to show larger improvements when compared to the IG, however, between-group comparisons did not reach significance. Conclusions: Results of this pilot RCT showed that an intensive, specific arm-hand BOOST program, on top of usual care, is feasible and safe in the sub-acute phase post stroke and suggests positive, clinical meaningful effects on upper limb function, especially when delivered in the early sub-acute phase post stroke. Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT04584177.

Project description:INTRODUCTION:Improvement of arm-hand function and arm-hand skill performance in stroke patients is reported by many authors. However, therapy content often is poorly described, data on actual arm-hand use are scarce, and, as follow-up time often is very short, little information on patients' mid- and long-term progression is available. Also, outcome data mainly stem from either a general patient group, unstratified for the severity of arm-hand impairment, or a very specific patient group. OBJECTIVES:To investigate to what extent the rate of improvement or deterioration of actual arm-hand use differs between stroke patients with either a severely, moderately or mildly affected arm-hand, during and after rehabilitation involving a well-defined rehabilitation program. METHODS:Design: single-armed prospective cohort study. Outcome measure: affected arm-hand use during daily tasks (accelerometry), expressed as 'Intensity-of arm-hand-use' and 'Duration-of-arm-hand-use' during waking hours. Measurement dates: at admission, clinical discharge and 3, 6, 9, and 12 months post-discharge. Statistics: Two-way repeated measures ANOVAs. RESULTS:Seventy-six patients (63 males); mean age: 57.6 years (sd:10.6); post-stroke time: 29.8 days (sd:20.1) participated. Between baseline and 1-year follow-up, Intensity-of-arm-hand-use on the affected side increased by 51%, 114% and 14% (p < .000) in the mildly, moderately and severely affected patients, respectively. Similarly, Duration-of-arm-hand-use increased by 26%, 220% and 161% (p < .000). Regarding bimanual arm-hand use: Intensity-of-arm-hand-use increased by 44%, 74% and 30% (p < .000), whereas Duration-of-arm-hand-use increased by 10%, 22% and 16% (p < .000). CONCLUSION:Stroke survivors with a severely, moderately or mildly affected arm-hand showed different, though (clinically) important, improvements in actual arm-hand use during the rehabilitation phase. Intensity-of-arm-hand-use and Duration-of-arm-hand-use significantly improved in both unimanual and bimanual tasks/skills. These improvements were maintained until at least 1 year post-discharge.

Dataset Information

Dynamic Lycra® orthoses as an adjunct to arm rehabilitation after stroke: a single-blind, two-arm parallel group, randomized controlled feasibility trial.

Publications

Dynamic Lycra® orthoses as an adjunct to arm rehabilitation after stroke: a single-blind, two-arm parallel group, randomized controlled feasibility trial.

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