- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07710937
Visual and Auditory Electromyography Biofeedback Among Stroke Patients
July 14, 2026 updated by: Adnan Hashim, University of Lahore
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
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.
Study Overview
Status
Active, not recruiting
Conditions
Detailed Description
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.
Study Type
Interventional
Enrollment (Estimated)
84
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Multan Khurd, Pakistan
- Nishtar Hospital Multan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Visual EMG Biofeedback + Conventional Physiotherapy
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).
|
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.
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.
|
|
Experimental: Auditory EMG Biofeedback + Conventional Physiotherapy
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).
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Balance (Berg Balance Scale)
Time Frame: 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.
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Baseline and Week 3 (Post-intervention)
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Functional mobility (Timed Up and Go Test)
Time Frame: Baseline and Week 3 (Post-intervention)
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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.
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Baseline and Week 3 (Post-intervention)
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Motor function (Fugl-Meyer Assessment-Lower Extremity)
Time Frame: Baseline and Week 3 (Post-intervention)
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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.
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Baseline and Week 3 (Post-intervention)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional independence (Barthel Index)
Time Frame: Baseline and Week 3 (Post-intervention)
|
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.
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Baseline and Week 3 (Post-intervention)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 9, 2026
Primary Completion (Estimated)
September 10, 2026
Study Completion (Estimated)
October 12, 2026
Study Registration Dates
First Submitted
July 14, 2026
First Submitted That Met QC Criteria
July 14, 2026
First Posted (Actual)
July 17, 2026
Study Record Updates
Last Update Posted (Actual)
July 17, 2026
Last Update Submitted That Met QC Criteria
July 14, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UOL/IREB/26/19/01/0002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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