Effect of a Home-based Gamified, Intensive, and Functional Tele-rehabilitation (Home-GIFT) program on improving upper limb function following stroke
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Assessment- Upper extremity
研究概览
简要总结
All stroke patients in the neurology ward and the OPD of Kasturba Hospital will be screened. Informed consent will be obtained from patients willing to participate. Baseline assessment will be conducted (Demographics, ARAT, Fugl Meyer Assessment UE, Motricity index, mRS, SIS 3.0, visual fatigue scale, kinematic measures of upper extremity reach). For the experimental group, home-based gamified, intensive, functional telerehabilitation (Home-GIFT using ArmAble Mini device) will be provided for approximately 45 mins to 1 hour per day. The therapy will be delivered at home, with the telemonitoring to track progress and ensure adherence, while the control group will follow a task-oriented program for about 45 min to 1 hour per day. Both groups should perform their exercises at home for 6 days per week for 4 weeks. Additionally, both groups will receive conventional therapy for 1 hour/day, 6 days/week for 4 weeks, followed by a home-based, functional rehabilitation program for another 4 weeks (~30 min/day, 6 days/week). This will be followed by a home-based functional exercise program (30 min/day, 6 days a week for 4 weeks). All outcome measures will be measured at baseline, 4-week post-intervention, and at the Completion of the follow-up assessment at the 8th week. Data obtained will be analysed using R Studio software.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •Diagnosed with acute or sub-acute unilateral stroke Hemodynamically stable participants having a stroke severity score more than 6 on the National Institute of Health Stroke Scale (NIHSS) A Chedoke-McMaster arm component score 2-6 in the affected upper limb The ability to sit with or without support and living in the community.
排除标准
- •Patients with unstable medical conditions/disease Uncooperative patients Patients with upper extremity musculoskeletal conditions/disease that preclude assessment and intervention (for e.g., Severe shoulder pain).
结局指标
主要结局
Fugl-Meyer Assessment- Upper extremity
时间窗: baseline, 4th week and 8th week
Action research arm test
时间窗: baseline, 4th week and 8th week
次要结局
- Motricity index score(Kinematic measures of upper extremity reach)
研究者
Dr Senthil Kumaran D
Manipal college of health professions
