Feasibility and Effectiveness of AI-powered Interactive Smartphone Application for a Self-directed Upper Limb Therapy Implementation After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Change in Action Research Arm Test
研究概览
简要总结
The aim of study is to investigate a newly developed AI smartphone application's feasibility, usefulness in improving users' experience, effect on adherence, UL use and recovery after stroke. The study is a prospective randomized controlled trial (RCT) to compare the implementation of AMPLIFY, a self-directed UL programme for people with stroke in two modes of delivery- hardcopy manual versus the mobile application. Eighty people with stroke within 4 weeks of stroke will be randomly allocated to either the experimental group (smartphone app) or control group (hardcopy manual) to undergone four weeks of AMPLIFY program. To compare the clinical effects of delivery AMPLIFY program via smartphone app versus hardcopy manual, assessments will be done at three time points- pre-intervention, post-intervention and three months post-intervention.
详细描述
Background To intensify practice to influence neuroplasticity to optimize UL recovery after stroke, it is important to empower people with stroke to perform self-directed UL therapy outside therapy. However, it has been found that increasing UL practice is often challenging with high level of inactivity found in people with stroke during rehabilitation. Traditionally, self-directed program has been delivered via hard copy manuals. Hardcopy manuals are often cumbersome and difficult to retrieve and handle, especially for those with moderate/severe UL impairment. Hence a more accessible format of exercise/activities instructions is needed. There is lack of reminders for people with stroke to keep up to prescribed exercise regime. This may affect adherence as some may not remember the prescribed practice sessions. Without immediate feedback of UL movement performed during self-practice, people with stroke may continue with compensatory movement performance without correction. This may in turns hinder UL recovery.
The aim of this study is to overcome these challenges by developing an AI-powered interactive smartphone application called AMPLIFY app that enables prescription and progression of exercises/functional activities, while offering immediate feedback on UL movement performed, real-time logging and monitoring of adherence through virtual platform. The inherent interactive nature of app offers features to engage and remind people with stroke to use their paretic UL. This app offers remote monitoring and supervision by therapists without need for actual therapists' physical presence. As the AMPLIFY app is a newly developed AI-powered interactive smartphone application, it is important to investigate the app's feasibility, usefulness in improving users' experience, effect on adherence, UL use, recovery and cost-effectiveness.
Aim:
To Investigate:
- Feasibility of AMPLIFY app in completing self-directed UL therapy programme
- Usefulness of AMPLIFY app in improving the users' experience in self-directed UL therapy programme performance
- Effectiveness of AMPLIFY app in increasing adherence in self-directed UL therapy programme performance
- Effectiveness of AMPLIFY app in increasing UL use, confidence and improving recovery after stroke
- Cost-effectiveness of AMPLIFY app in reducing the need for clinical review in self-directed UL therapy programme performance
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcome assessor will be blinded to which group the research participants are in
入排标准
- 年龄范围
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of stroke (confirmed by CT/MRI scans)
- •≤four weeks post-stroke
- •Montreal Cognitive Assessment (MOCA)>=21
- •Finger extension Medical Research Council (MRC) >=1
- •Fugl Meyer Upper Limb score <60 or NIHSS Motor Arm section score>=2
- •Potential discharge to home (able to do tele-rehabilitation for review)
排除标准
- •Bilateral stroke
- •Montreal Cognitive Assessment (MOCA)<21
- •Paretic upper limb numeric pain rating scale (NPRS)>5
- •Reduced paretic upper limb use prior to stroke episode (e.g. frozen shoulder, fracture, etc)
- •Reduced paretic upper limb use due to orthopaedic problems such as fracture in existing stroke episode
- •Medically unstable
- •Neglect as ascertained by treatment team
- •Severe behavioural disturbance or agitation or epilepsy or untreated depression or psychiatric conditions
- •Pregnancy or lactation states
结局指标
主要结局
Change in Action Research Arm Test
时间窗: Change from pre-intervention to immediate post-intervention
Change in Action Research Arm Test (minimum score 0 - maximum score 57; the higher the score the better the upper limb performance)
次要结局
- Change in Upper Limb Self-Efficacy Test(Change from immediate post-intervention to 3 month post-intervention)
- Change in Action Research Arm Test(Change from immediate post-intervention to 3 month post-intervention)
- Change in Rating of Everyday Arm-use in the Community and Home(Change from immediate post-intervention to 3 month post-intervention)
- Change in Stroke Rehabilitation Motivation Scale (SRMS)(Change from immediate post-intervention to 3 month post-intervention)
- Feasibility - Number of drop-out(Throughout the 4 weeks of intervention)
- User Experience Survey(End of 4 weeks intervention)
- Change in Stroke Rehabilitation Motivation Scale(Change from pre-intervention to immediate post-intervention)
- Change in upper limb Modified Ashworth Scale(Change from immediate post-intervention to 3 month post-intervention)
- Feasibility- Number of adverse events related to AMPLIFY Programme(Throughout the 4 weeks of intervention)
- Affinity for Technology Interaction Scale(Pre-intervention)
- Change in upper limb pain visual analogue scale(Change from immediate post-intervention to 3 month post-intervention)
- AMPLIFY Programme Adherence(Throughout the 4 weeks of intervention)
- Number of upper limb repetitions performed in AMPLIFY Programme(Throughout the 4 weeks of intervention)
- Number of Clinical Reviews in AMPLIFY Programme(Throughout the 4 weeks of intervention)