Functional electrical stimulation versus mirror therapy to improve foot clearance after subacute stroke
Comparative Effects of Functional Electrical Stimulation and Mirror Therapy for Foot Clearance Among Patients With Sub-acute Stroke
This trial tests whether adding functional electrical stimulation or mirror therapy to routine physical therapy better improves foot clearance for adults (18–85) recovering from a subacute stroke.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Lahore University of Biological and Applied Sciences Academic / other |
| Locations | 2 sites (Lahore, Punjab Province and 1 other locations) |
| Trial ID | NCT07448532 on ClinicalTrials.gov |
What this trial studies
This randomized interventional trial will assign adults with subacute stroke and impaired foot clearance to receive either functional electrical stimulation (FES) plus routine physical therapy or mirror therapy (MT) plus routine physical therapy three times weekly for four weeks. Eligible participants (within six months of stroke, FMA-LE ≥20, FAC 3–4, able to walk on a treadmill for at least 2 minutes, and MMSE >24) will undergo baseline and post-intervention motor assessments including the Fugl-Meyer Assessment and the Functional Independence Measure. The primary focus is on changes in foot clearance and lower-limb motor recovery measured before and after the intervention. The trial is conducted at Lahore University of Biological and Applied Sciences and uses standardized physical-therapy sessions with sensory augmentation or neuromodulation techniques.
Who should consider this trial
Good fit: Adults aged 18–85 with a subacute stroke (≤6 months), FMA-LE ≥20, FAC score of 3 or 4, intact peripheral nerves and muscles, ability to walk on a treadmill for at least 2 minutes, and MMSE >24 are ideal candidates.
Not a fit: Patients with severe lower-limb paralysis (FMA-LE <20), inability to ambulate to the required level, major cognitive impairment, orthopedic contraindications, or contraindications to electrical stimulation are unlikely to benefit from these interventions.
Why it matters
Potential benefit: If one approach proves better, it could improve walking safety and independence by increasing foot clearance after subacute stroke.
How similar studies have performed: Previous studies have reported promising effects of both FES and mirror therapy on motor recovery after stroke, but direct head-to-head comparisons for improving foot clearance in the subacute phase are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient aged 18-85 years of age, who experienced stroke within ≤6 months. * The Fugl-Meyer motor assessment of lower extremity (FMA-LE) was conducted by physiotherapist in the hospital, and score required to be ≥ 20 points. * Participants possessed healthy nerves, neuromuscular junctions, muscles tissues, and a sufficient range of motion in dorsiflexor and plantarflexion. * The subjects could walk independently on a treadmill for at least 2 min without without experiencing adverse reaction to FES. * Patients who received more 24 scores on Mini Mental State Exam and could comprehend and follow the information researcher provides. * No orthopedic diseases in upper and lower extremities. * Patients with functional ambulation classification (FAC) score of 3 or 4 were included (FAC is a scale of 0-5, where 3 indicates supervision or standby guarding and 4 indicates independent on level surfaces. * Patients with inadequate ankle dorsiflexion during the swing phase of gait. * Patients with adequate minimal stability at the ankle during stance with stimulation. Exclusion Criteria: * Patients with cardiac pacemaker, those with skin lesions, who could not be treated due to spasticity within the last three months, and vestibular and cerebellar lesions or deaf- blindness were excluded. * Patients with past or current epilepsy, uncontrolled seizure disorder, mental disorders and all neurological disorders except stroke. * Patients with severe edema of lower extremities or patients of vascular disorders like deep vein thrombosis or thromboembolisms and severe atheroscelerosis of lower extremities. * Subjects with any musculoskeletal dysfunction that would potentially affect gait and causes risk of falls. * We excluded patients with pregnancy, plantar flexion contracture, and severe hemi-neglect. * Subjects with hip or knee prostheses made of metal on the lower limb were excluded.
Where this trial is running
Lahore, Punjab Province and 1 other locations
- Lahore University of Biological and Applied Sciences — Lahore, Punjab Province, Pakistan (Recruiting)
- Lahore University of Biological and Applied Sciences — Lahore, Punjab Province, Pakistan (Recruiting)
Study contacts
- Principal investigator: Rohma Shah — Lahore College of Physical Therapy
- Study coordinator: Nabeela Dawood
- Email: nabeela.dawood@ubas.edu.pk
- Phone: +923315337445
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.