Task-Specific Self-Rehabilitation Training (TASSRET) Trial

Overview

The goal of this pilot RCT is to evaluate the effectiveness of a Task-specific Self-rehabilitation Training (TASSRET) program and compare the effect of the two formats of the TASSRET (video vs manual) on functional ability (upper extremity fine and gross motor skills, upper extremity manual dexterity and speed, voluntary movement and basic mobility, gait velocity, balance) and health-related quality of life among Hausa-native stroke survivors. The main questions it aims to answer are: 1. What is the immediate effect and durability of TASSRET on functional ability (upper extremity fine and gross motor skills, upper extremity manual dexterity and speed, voluntary movement and basic mobility, gait velocity, balance) and health-related quality of life among the Hausa-native stroke survivors? 2. Which of the self-rehabilitation formats (TASSRET-manual or TASSRET-video) is more effective (immediate and durable) at improving functional ability (upper extremity fine and gross motor skills, upper extremity manual dexterity and speed, voluntary movement and basic mobility, gait velocity, balance) and health-related quality of life among the Hausa-native stroke survivors?

Stroke is a major cause of acquired adult neurological disability worldwide, with its incidence showing a concerning upward trend in low- and middle-income countries (LMICs) over the past decade. This rise in stroke cases implies a growing burden of post-stroke disability, where functional limitations affect many survivors long-term. Approximately one-third of first-time stroke survivors may experience physical disabilities lasting five years or more, adversely impacting their community integration and quality of life. In community settings, particularly in LMICs, access to therapy and rehabilitation services is severely limited compared to hospital environments. A recent systematic review highlighted the scarcity of high-quality, evidence-based research on rehabilitation strategies to improve functional mobility after stroke in LMICs, especially interventions that can be self-administered. Much of the existing evidence for home-based, self-administered post-stroke rehabilitation, including that based on best-practice guidelines, comes from studies in high-income countries (HICs). These models are often unsuitable for LMICs due to feasibility and affordability issues. Another systematic review of 62 studies demonstrated that exercise-based and brain training interventions can enhance functional outcomes in LMICs post-stroke. Although techniques promoting neuroplasticity exist, task-specific training (TST) shows promise for improving outcomes in these settings. However, research on TST protocols in LMICs is limited by small sample sizes, lack of self-administration features, inadequate descriptions of exercise parameters like type, intensity, and frequency, and a focus on non-community-based settings. To address these gaps, two formats of a task-specific self-rehabilitation training program (TASSRET-video and TASSRET-manual) were developed for use in developing countries. This protocol outlines a pilot randomized controlled trial (RCT) to investigate their effectiveness in enhancing functional mobility among community-dwelling stroke survivors. Ethical approval was obtained from the Bayero University Kano Health Research Ethics Committee (NHREC/BUK-HREC/06/12/119/5). Permissions will be sought from community leaders, and recruitment will occur through health centers. Written consent will be obtained from all eligible participants before enrollment, in line with ethical standards. The study employs a two-arm, outcome assessor-blinded RCT design. Participants will be randomly assigned to either the TASSRET-video or TASSRET-manual group following consent and baseline assessment. This design is chosen for its rigor in hypothesis testing and as the gold standard for evaluating intervention effectiveness. The target population consists of Hausa-native adult stroke survivors residing in the rural communities of Kura, Karfi, and Dan Hassan in Kano State, Nigeria. 50 participants (25 per group) will be involved in this study. This was determined using G\*Power software version 3.1.9.7. Recruitment will involve community leaders identifying and introducing potential participants. Two experienced research assistants will assist in this process, collecting phone contacts and approaching individuals. Consecutive sampling will be used, enrolling eligible participants until the sample size is reached. Following baseline data collection, participants will be randomized using block randomization. An independent statistician will generate the sequence via a computer program, excluding involvement in recruitment, treatment, or assessment. Allocation will be concealed in sequentially numbered, sealed, opaque envelopes, revealed only at assignment. Outcome assessors and data entry personnel will remain blinded to group allocation, and participants will be instructed not to disclose their group. The interventions consist of two groups. In the TASSRET-video group, participants will receive the program via video clips transferred to their Android phones using a file-sharing application. The app includes an introductory video on usage, followed by sections on upper extremity function, lower extremity and balance function, and trunk strength. Each section begins with instructions, and participants select sessions based on needs, performing tasks while following video demonstrations with Hausa verbal explanations. They start with at least 10 repetitions per task, increasing by 50% weekly up to 300 maximum, conducted twice daily, three times per week for six weeks, preceded by warm-up exercises shown in the video. The TASSRET-manual group will receive a printed manual with the same tasks, featuring pictures of demonstrations and Hausa text descriptions. Participants follow these to perform exercises, matching the video group's frequency, repetitions, and duration. Both groups are encouraged to involve family caregivers for assistance. Outcomes include various measures assessed at baseline, six weeks post-intervention, and three-month follow-up. These encompass upper and lower extremity function via the Stroke Rehabilitation Assessment of Movement (STREAM), fine motor skills with the Action Research Arm Test (ARAT) and Box and Block Test (BBT), arm and hand activity using the Chedoke Arm and Hand Activity Inventory, gait with the 10-Meter Walk Test (10MWT) and 6-Minute Walk Test (6MWT), dynamic balance through the Mini-Balance Evaluation System Test (Mini-BEST), spasticity with the Modified Ashworth Scale, muscle strength using the Medical Research Council scale, quality of life via the Stroke Impact Scale (SIS), and adverse events reported by participants. Three trained research assistants will handle assessments, each focusing on specific outcomes: one for motor skills, mobility, and adverse effects; another for dexterity, spasticity, and strength; the third for balance and gait. They will also assist in scoring the SIS for illiterate participants. Adverse events, such as discomfort or incidents, will be documented during and after intervention. Data collection occurs at baseline (including socio-demographics and clinical info), six weeks, and three months. Each participant's data will be stored in a folder, recorded in a booklet, and entered into password-protected Microsoft Excel 2016. Hard copies will be secured. Deviations or discontinuities will be documented with reasons. Baseline comparisons will use Mann-Whitney U or Chi-square tests of difference. Intention-to-treat with last observation carried forward will handle missing data. Repeated-measures MANOVA will examine within-subject effects, time effects, and time-by-group interactions. Univariate tests and Bonferroni-adjusted pairwise comparisons will evaluate immediate and sustained effects, with significance at p ≤ 0.05. This pilot RCT fills a key gap in stroke rehabilitation by assessing the feasibility and initial effectiveness of self-administered TASSRET formats for community-dwelling survivors in low-resource areas. Strengths include the randomized, blinded design, validated measures, and cultural-linguistic adaptation for Hausa speakers. Comparing video and manual formats will reveal optimal delivery methods for LMICs with limited physiotherapy access. Findings will support a larger RCT to verify TASSRET's effectiveness. The tailored approach could model scalable, affordable rehabilitation for other LMICs, improving mobility and quality of life in underserved populations.