Effect of Technology-Based Trunk Training versus Conventional Therapy on the Rate of Recovery of Trunk in Individuals with Acute Stroke – A Pilot RCT
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1. Trunk Impairment Scale (TIS)
研究概览
简要总结
This pilot randomized controlled trial aims to compare the rate of trunk recovery in individuals with acute stroke undergoing conventional physiotherapy versus technology-based trunk training using the BTrackS Balance Tracking System. Thirty participants with first-onset stroke will be randomized into two groups. The intervention group will receive conventional physiotherapy followed by visual feedback-based trunk training using the BTrackS system. The control group will receive conventional physiotherapy with BTrackS training but without visual feedback. The primary outcome measures include the Trunk Impairment Scale and Function in Sitting Test assessed daily for five days. The study also evaluates feasibility, adherence, and participant feedback. The trial will be conducted in the Neurorehabilitation Unit of Kasturba Hospital, Manipal, over a period of twelve months. Ethical approval has been obtained and CTRI registration is being completed prospectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •First-ever stroke confirmed by CT or MRI
- •Trunk Control Test score less than 60
- •Medically stable for participation 5.
排除标准
- •Participants advised complete bed rest
- •Severe visual impairment interfering with participation
- •Conditions limiting sitting (e.g., hip fracture).
结局指标
主要结局
1. Trunk Impairment Scale (TIS)
时间窗: 1. Baseline (Day 1) and daily post-treatment (Day 1 to Day 5) | 2. Baseline (Day 1) and daily post-treatment (Day 1 to Day 5)
2. Function in Sitting Test (FIST)
时间窗: 1. Baseline (Day 1) and daily post-treatment (Day 1 to Day 5) | 2. Baseline (Day 1) and daily post-treatment (Day 1 to Day 5)
次要结局
- Feasibility Metrics (Recruitment rate, Adherence rate, Dropout rate, Participant feedback)(Throughout intervention period (Day 1 to Day 5))
研究者
Dr Abhipsha Majumder
Manipal College of Health Proessions, Manipal Academy of Higher Education, Manipal