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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Visual EMG Biofeedback + Conventional Physiotherapy | Experimental | Participants assigned to this arm will receive 10 minutes of conventional physiotherapy followed by 20 minutes of visual electromyography (EMG) biofeedback training. Surface EMG electrodes will be applied to the tibialis anterior muscle of the affected lower extremity. Real-time visual feedback displayed on a monitor will guide voluntary muscle activation to improve balance, motor recovery, functional mobility, and functional independence. Treatment will be provided for 30 minutes per session, five sessions per week for three weeks (15 sessions). |
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| Auditory EMG Biofeedback + Conventional Physiotherapy | Experimental | Participants assigned to this arm will receive 10 minutes of conventional physiotherapy followed by 20 minutes of auditory electromyography (EMG) biofeedback training. Surface EMG electrodes will be applied to the tibialis anterior muscle of the affected lower extremity. Muscle activation will be translated into real-time auditory cues to facilitate voluntary muscle contraction, motor relearning, and improvement in balance and functional mobility. Treatment will be provided for 30 minutes per session, five sessions per week for three weeks (15 sessions). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visual Electromyography Biofeedback | Device | Surface electromyography biofeedback will provide real-time visual feedback of muscle activity from the tibialis anterior muscle using graphical displays on a monitor. Participants will perform task-oriented lower extremity exercises while observing muscle activation to facilitate motor relearning and improve balance, functional mobility, and lower extremity motor function. The intervention will be delivered for 20 minutes per session, five sessions per week for three weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Balance (Berg Balance Scale) | 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. | Baseline and Week 3 (Post-intervention) |
| Functional mobility (Timed Up and Go Test) | 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. | Baseline and Week 3 (Post-intervention) |
| Motor function (Fugl-Meyer Assessment-Lower Extremity) | 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. | Baseline and Week 3 (Post-intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Functional independence (Barthel Index) | Functional independence will be assessed using the Barthel Index (BI). The BI evaluates independence in activities of daily living, with scores ranging from 0 to 100. Higher scores indicate greater functional independence. | Baseline and Week 3 (Post-intervention) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nishtar Hospital Multan | Multan Khurd | Pakistan |
Individual participant data will not be shared because this study was conducted as an academic research project. The informed consent obtained from participants did not include provisions for public data sharing, and the dataset contains sensitive personal health information. Data will be stored securely and used only for academic and research purposes in accordance with institutional ethics approval.
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D006429 | Hemiplegia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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This is a two-arm, parallel-group, randomized controlled trial. Eligible participants with stroke will be randomly assigned in a 1:1 ratio to either the Visual Electromyography (EMG) Biofeedback plus Conventional Physiotherapy group or the Auditory Electromyography (EMG) Biofeedback plus Conventional Physiotherapy group using a computer-generated randomization sequence with sealed-envelope allocation concealment. Both groups will receive identical conventional physiotherapy for 10 minutes followed by 20 minutes of their assigned EMG biofeedback intervention. Treatment will be administered five sessions per week for three weeks (15 sessions). Outcome measures will be assessed at baseline and immediately after completion of the intervention by a blinded outcome assessor.
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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.
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| Auditory Electromyography Biofeedback | Device | Surface electromyography biofeedback will provide real-time auditory feedback corresponding to muscle activation of the tibialis anterior muscle. Participants will perform task-oriented lower extremity exercises while using auditory cues to facilitate muscle activation, movement coordination, and motor recovery. The intervention will be delivered for 20 minutes per session, five sessions per week for three weeks. |
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| Conventional Physiotherapy | Other | Conventional physiotherapy will consist of lower extremity strengthening exercises, task-oriented functional training, balance exercises, gait training, stretching, and mobility exercises. All participants will receive 10 minutes of conventional physiotherapy before EMG biofeedback during each treatment session. The intervention will be delivered five sessions per week for three weeks. |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |