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临床试验/CTRI/2025/04/084323
CTRI/2025/04/084323招募中2 期

Effect of a Home-based Gamified, Intensive, and Functional Tele-rehabilitation (Home-GIFT) program on improving upper limb function following stroke

Medical Instruments Devices Allied Services Department of Science and Technology Hub1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年4月15日最近更新:

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

发起方
Medical Instruments Devices Allied Services Department of Science and Technology Hub
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Dr Senthil Kumaran D

Manipal college of health professions

研究点 (1)

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