[ARTICLE] Encouragement-induced real-world upper limb use after stroke by a tracking and feedback device: a study protocol for a multi-center, assessor-blinded, randomized controlled trial – Full Text

Introduction: Retraining the paretic upper limb after stroke should be intense and specific to be effective. Hence, the best training is daily life use, which is often limited by motivation and effort. Tracking and feedback technology have the potential to encourage self-administered, context-specific training of upper limb use in the patients’ home environment. The aim of this study is to investigate post-intervention and long-term effects of a wrist-worn activity tracking device providing multimodal feedback on daily arm use in hemiparetic subjects beyond 3 months post-stroke.

Methods and Analysis: A prospective, multi-center, assessor-blinded, Phase 2 randomized controlled trial with a superiority framework. Sixty-two stroke patients will be randomized in two groups, with a 1:1 allocation ratio, stratified based on arm paresis severity (Fugl-Meyer Assessment – Upper Extremity subscale <32 and ≥32). The experimental group receives a wrist-worn activity tracking device providing multimodal feedback on daily arm use for 6 weeks. Controls wear an identical device providing no feedback. Sample size: 31 participants per group, based on a difference of 0.75±1.00 points on the Motor Activity Log – 14 Item Version, Amount of Use subscale (MAL-14 AOU), 80% power, two-sided alpha of 0.05, and a 10% attrition rate.

Outcomes: Primary outcome is the change in patient-reported amount of daily life upper limb use (MAL-14 AOU) from baseline to post-intervention. Secondary outcomes are change in upper limb motor function, upper limb capacity, global disability, patient-reported quality of daily life upper limb use, and quality of life from baseline to post-intervention and 6-week follow-up, as well as compliance and safety.

Discussion: The results of this study will show the possible efficacy of a wrist-worn tracking and feedback device on patient-reported amount of daily life upper limb use.

Ethics and Dissemination: The study is approved by the Cantonal Ethics Committees Zurich, and Northwest and Central Switzerland (BASEC-number 2017-00948) and registered in https://clinicaltrials.gov (NCT03294187) before recruitment started. This study will be carried out in compliance with the Declaration of Helsinki, ICH-GCP, ISO 14155:2011, and Swiss legal and regulatory requirements. Dissemination will include submission to a peer-reviewed journal, patient and healthcare professional magazines, and congress presentations.

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[Abstract] Does Task-Specific Training Improve Upper Limb Performance in Daily Life Poststroke?

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Abstract

Background. A common assumption is that changes in upper limb (UL) capacity, or what an individual is capable of doing, translates to improved UL performance in daily life, or what an individual actually does. This assumption should be explicitly tested for individuals with UL paresis poststroke.

Objective. To examine changes in UL performance after an intensive, individualized, progressive, task-specific UL intervention for individuals at least 6 months poststroke.

Methods. Secondary analysis on 78 individuals with UL paresis who participated in a phase II, single-blind, randomized parallel dose-response trial. Participants were enrolled in a task-specific intervention for 8 weeks. Participants were randomized into 1 of 4 treatment groups with each group completing different amounts of UL movement practice. UL performance was assessed with bilateral, wrist-worn accelerometers once a week for 24 hours throughout the duration of the study. The 6 accelerometer variables were tested for change and the influence of potential modifiers using hierarchical linear modeling.

Results. No changes in UL performance were found on any of the 6 accelerometer variables used to quantify UL performance. Neither changes in UL capacity nor the overall amount of movement practice influenced changes in UL performance. Stroke chronicity, baseline UL capacity, concordance, and ADL status significantly increased the baseline starting points but did not influence the rate of change (slopes) for participants.

Conclusions. Improved motor capacity resulting from an intensive outpatient UL intervention does not appear to translate to increased UL performance outside the clinic.

Source: Does Task-Specific Training Improve Upper Limb Performance in Daily Life Poststroke? – Mar 01, 2017