Functional electrical stimulation versus mirror therapy to improve foot clearance after subacute stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.