Visual and Auditory Electromyography Biofeedback Among Stroke Patients

NCT07710937 | Active Not Recruiting

• 1 other identifier: UOL/IREB/26/19/01/0002
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke; Hemiplegia; Stroke Rehabilitation

Keywords

Stroke; Hemiplegia; Electromyography Biofeedback; Visual Biofeedback; Auditory Biofeedback

Outcome Measures

Primary Outcomes (3)

• 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)

Secondary Outcomes (1)

• Functional independence (Barthel Index)

  Baseline and Week 3 (Post-intervention)

Study Arms (2)

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).

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).

Device: Auditory Electromyography Biofeedback; Other: Conventional Physiotherapy

Interventions

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.

Auditory EMG Biofeedback + Conventional Physiotherapy; Visual EMG Biofeedback + Conventional Physiotherapy

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.

Visual EMG Biofeedback + Conventional Physiotherapy

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.

Auditory EMG Biofeedback + Conventional Physiotherapy

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

Nishtar Hospital Multan

Multan Khurd, Pakistan

Location

MeSH Terms

Conditions

Stroke; Hemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Physical Therapy Student

Model Details: 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.

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 17, 2026
• Study Start: April 9, 2026
• Primary Completion (Estimated): September 10, 2026
• Study Completion (Estimated): October 12, 2026
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)