StrokeNCT07710937
Visual and Auditory Electromyography Biofeedback Among Stroke Patients
A study testing Visual Electromyography Biofeedback, Auditory Electromyography Biofeedback and Conventional Physiotherapy in people with Stroke and Hemiplegia, run by University of Lahore at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Stroke, Hemiplegia, Stroke Rehabilitation
- What is being tested?
- Visual Electromyography Biofeedback, Auditory Electromyography Biofeedback and Conventional Physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 sitePakistan
- Study dates
- 9 Apr 2026to 12 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke, Hemiplegia, Stroke Rehabilitation
- Being tested
- Visual Electromyography Biofeedback, Auditory Electromyography Biofeedback, Conventional Physiotherapy
- Keywords
- Stroke, Hemiplegia, Electromyography Biofeedback, Visual Biofeedback, Auditory Biofeedback
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual Electromyography BiofeedbackDevice
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.
Auditory Electromyography BiofeedbackDevice
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.
Conventional PhysiotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Visual Electromyography Biofeedback; Other: Conventional Physiotherapy |
| 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). Receives: Device: Auditory Electromyography Biofeedback; Other: Conventional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 3 (Post-intervention)
Secondary outcomes (1)
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.
Measured: Baseline and Week 3 (Post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start9 Apr 2026
- Primary completion10 Sep 2026
- Study completion12 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adnan Hashim, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07710937
- Sponsor's protocol ID
- UOL/IREB/26/19/01/0002
- Status last verified
- Oct 2026
- First submitted
- 14 Jul 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07710937
- Acronym / sponsor ID
- UOL/IREB/26/19/01/0002
- Conditions
- Stroke, Hemiplegia, Stroke Rehabilitation
- Keywords
- Stroke, Hemiplegia, Electromyography Biofeedback, Visual Biofeedback, Auditory Biofeedback
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 9 Apr 2026 (actual)
- Primary completion
- 10 Sep 2026 (actual)
- Study completion
- 12 Oct 2026 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Visual EMG Biofeedback + Conventional Physiotherapy | Experimental | Device: Visual Electromyography Biofeedback, Other: Conventional PhysiotherapyParticipants 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). |
| Auditory EMG Biofeedback + Conventional Physiotherapy | Experimental | Device: Auditory Electromyography Biofeedback, Other: Conventional PhysiotherapyParticipants 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). |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual Electromyography BiofeedbackSurface 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. | Device | Visual EMG Biofeedback + Conventional Physiotherapy |
| Auditory Electromyography BiofeedbackSurface 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. | Device | Auditory EMG Biofeedback + Conventional Physiotherapy |
| Conventional PhysiotherapyConventional 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. | Other | Auditory EMG Biofeedback + Conventional Physiotherapy, Visual EMG Biofeedback + Conventional Physiotherapy |
Primary outcome
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.
Functional mobility (Timed Up and Go Test)
Time frame: 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)
Time frame: 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.
1 secondary outcome
Functional independence (Barthel Index)
Time frame: Baseline and Week 3 (Post-intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual Electromyography Biofeedback, Auditory Electromyography Biofeedback and Conventional Physiotherapy in people with Stroke and Hemiplegia, run by University of Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance (Berg Balance Scale) (time frame: Baseline and Week 3 (Post-intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.