Comparative Effects of Visual and Auditory Electromyography Biofeedback Combined With Conventional Physiotherapy on Balance, Functional Mobility, Motor Function, and Functional Independence Among Patients With Stroke: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Balance (Berg Balance Scale)
研究概览
简要总结
Stroke commonly results in impairments of balance, mobility, and lower extremity motor function that limit independence in daily activities. Electromyography (EMG) biofeedback enhances motor relearning by providing real-time feedback regarding muscle activation. Although both visual and auditory EMG biofeedback have demonstrated benefits in stroke rehabilitation, evidence directly comparing these feedback modalities remains limited. This randomized controlled trial aims to compare the effects of visual and auditory EMG biofeedback, each combined with conventional physiotherapy, on balance, functional mobility, motor function, and functional independence in individuals with stroke.
详细描述
This randomized controlled trial will compare two modes of electromyography biofeedback in individuals with stroke undergoing lower extremity rehabilitation. Eighty-four eligible participants will be randomly allocated into two parallel groups using sealed-envelope randomization. Both groups will receive conventional physiotherapy consisting of lower extremity strengthening, balance, gait, and task-oriented exercises for 10 minutes per session. The experimental intervention will consist of either visual or auditory EMG biofeedback applied to the tibialis anterior muscle for 20 minutes. Treatment will be provided five sessions per week over three weeks (15 sessions). Outcomes including balance (Berg Balance Scale), functional mobility (Timed Up and Go Test), motor recovery (Fugl-Meyer Assessment-Lower Extremity), and functional independence (Barthel Index) will be assessed at baseline and immediately after completion of the intervention by a blinded assessor.
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
This study will employ a single-blind design. The outcome assessor responsible for evaluating balance, functional mobility, motor function, and functional independence will remain blinded to group allocation throughout the study. Participants and treating physiotherapists cannot be blinded because the intervention modality (visual or auditory EMG biofeedback) is readily identifiable during treatment sessions. Measures will be taken to ensure that the assessor does not have access to treatment allocation information.
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 20 and 30 years
- •Male or female participants
- •Clinically diagnosed hemiplegic stroke.
- •Medically stable and able to participate in rehabilitation.
- •No visual impairment that would interfere with visual biofeedback.
- •No hearing impairment that would interfere with auditory biofeedback.
- •No sensory aphasia affecting the ability to understand study instructions.
排除标准
- •Traumatic injury or lesion affecting the lower extremities
- •Lower-limb amputation
- •Severe systemic disease that could interfere with participation
- •Peripheral vascular disease affecting the lower extremities
- •Fixed ankle contracture
- •Motion sickness or intolerance to rehabilitation technology
结局指标
主要结局
Balance (Berg Balance Scale)
时间窗: Baseline and Week 3 (Post-intervention)
Balance will be assessed using the Berg Balance Scale (BBS), a 14-item performance-based measure of static and dynamic balance. Scores range from 0 to 56, with higher scores indicating better balance performance.
Functional mobility (Timed Up and Go Test)
时间窗: Baseline and Week 3 (Post-intervention)
Functional mobility will be assessed using the Timed Up and Go (TUG) Test. The time (seconds) required to stand from a chair, walk 3 meters, turn, return, and sit will be recorded. Lower completion times indicate better functional mobility.
Motor function (Fugl-Meyer Assessment-Lower Extremity)
时间窗: Baseline and Week 3 (Post-intervention)
Motor function will be assessed using the Fugl-Meyer Assessment-Lower Extremity (FMA-LE). The FMA-LE contains 17 items with a total score ranging from 0 to 34. Higher scores indicate greater motor recovery.
次要结局
- Functional independence (Barthel Index)(Baseline and Week 3 (Post-intervention))
研究者
Adnan Hashim
Doctor of Physical Therapy Student
University of Lahore