Study Protocol for a Pilot Randomized Controlled Trial of Task-Specific Self-Rehabilitation Training (TASSRET) for Improving Functional Mobility in Community-Dwelling Stroke Survivors in a Low-Resource Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Action Research Arm Test (ARAT)
研究概览
简要总结
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:
- 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?
- 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?
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Stattitician
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are aged 18 years or older
- •Diagnosed with a first-ever episode of ischemic or haemorrhagic stroke (including intracerebral haemorrhage and subarachnoid haemorrhage)
- •Speaks and understands the Hausa language
- •Living within the community and having no access to physiotherapy care
- •Having access to an Android phone
- •More than 10-degree extension of the index finger and abduction of the thumb
- •Cognitive ability to follow commands, as indicated by a score of 0 to 1 on the Commands item of the National Institutes of Health Stroke Scale or a Mini-Mental State Examination score of ≥24
- •Ability to stand and take a step (with or without support).
排除标准
- •Had cerebrovascular events due to malignancy or head trauma
- •Had been diagnosed with other neurological disorders
- •Were not permanent residents of the selected communities
- •Were currently receiving any form of physical rehabilitation.
研究组 & 干预措施
TASSRET-manual
2. TASSRET-manual: Participants in this group will be given the TASSRET-manual, which contains the same task training as the video version. The manual covers pictures of individuals demonstrating the tasks with a corresponding text description in the Hausa language. Participants will be instructed to follow the images and text descriptions to perform the tasks, mirroring the training process in the video group. The frequency, number of repetitions, and duration of the intervention are the same as in the TASSRET-video group.
干预措施: Manual-based Task-specific Training (Behavioral)
TASSRET-video
Participants in this group will use the TASSRET-video, which will be transferred to their phones via Xender (a file-sharing app). The application is user-friendly and features video clips of individuals demonstrating task training, accompanied by verbal explanations in Hausa. Upon opening the app, participants first view an introductory video on how to use the application. They can then navigate through three main sections: training for upper extremity function, training for lower extremity and balance function, and training for trunk strength. Each section starts with an instructional video.
Participants will be required to select training sessions based on their rehabilitation needs, follow the videos, and perform the tasks, starting with ten repetitions or more (depending on comfort) per session. The number of repetitions is to be increased by at least 50% weekly, not exceeding a maximum of 300 repetitions per session. The training will be performed twice daily, three times per wee
干预措施: Video-based Task-specific Training (Behavioral)
结局指标
主要结局
Action Research Arm Test (ARAT)
时间窗: Baseline, six weeks post-intervention and three-month follow-up.
This is a measure of upper extremity fine and gross motor skills. The scale ranges from 0 to 57, with higher scores indicating better upper extremity fine and gross motor skills.
Stroke Rehabilitation Assessment of Movement (STREAM)
时间窗: Baseline, six weeks post-intervention and three-month follow-up.
A measure of voluntary movement and basic mobility. The scale ranges from o to 100, with higher scores indicating better voluntary movement and basic mobility.
Box and Block Test (BBT)
时间窗: Baseline, six weeks post-intervention and three-month follow-up.
This measure manual dexterity and speed. The assessment is based on the number of blocks transferred from one compartment to the other within one minute. Higher scores indicate better manual dexterity and speed.
Ten-Meter Walk Test (10MWT)
时间窗: Baseline, six weeks post-intervention and three-month follow-up.
A measure of gait velocity. This is the time taken to walk a distance of ten meters, it is reported in meter per second. Lower scores indicate better gait velocity.
Mini-Balance Evaluation System Test (Mini-BEST)
时间窗: Baseline, six weeks post-intervention and three-month follow-up.
This is a measure of dynamic balance. The scores range from 0 to 28, with higher scores indicating better dynamic balance.
Stroke Impact Scale (SIS)
时间窗: Baseline, six weeks post-intervention and three-month follow-up.
A self-reported measure of health-related quality of life. The scores range from 0 to 100, with higher scores indicating better perceived health-related quality of life.
次要结局
- Modified Ashworth scale (MAS)(Baseline, six weeks post-intervention and three-month follow-up.)
- Manual Muscle Testing (MMT)(Baseline, six weeks post-intervention and three-month follow-up.)
研究者
Rabiu Ibrahim
Director of Physiotherapy
National Assembly Clinic
