Hemiplegia, Stroke, Stroke Rehabilitation
Conditions
Keywords
Stroke, Hemiplegia, Electromyography Biofeedback, Visual Biofeedback, Auditory Biofeedback
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.
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.
Interventions
DEVICEVisual Electromyography Biofeedback
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.
DEVICEAuditory Electromyography Biofeedback
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.
OTHERConventional Physiotherapy
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.
Sponsors
University of Lahore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Balance (Berg Balance Scale) | 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) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional independence (Barthel Index) | 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. |
Countries
Pakistan
Outcome results
None listed