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NCT07914413

Foot Drop Rehabilitation and Mobility in Chronic Stroke

Sponsor: Umm Al-Qura University

View on ClinicalTrials.gov

Summary

Stroke is a leading cause of long-term disability, frequently resulting in motor impairments, balance deficits, and walking difficulties that limit functional independence and quality of life. Conventional rehabilitation approaches, including gait training and assistive devices, may not fully address these limitations. Functional electrical stimulation (FES) offers a complementary approach by activating targeted muscles through electrical impulses, potentially improving ankle control, gait performance, and mobility in individuals with post-stroke foot drop. However, variations in clinical outcomes, treatment protocols, and accessibility highlight the need for further investigation. Therefore, this study aims to evaluate the effects of FES on functional mobility and quality of life in individuals with chronic stroke.

Official title: Impact of Foot Drop Rehabilitation on Functional Mobility and Quality of Life in Patients With Chronic Stroke: A Randomized Controlled Trial

Key Details

Gender

MALE

Age Range

50 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-11

Completion Date

2027-11

Last Updated

2026-11-03

Healthy Volunteers

Conditions

Stroke

Interventions

OTHER

Conventional Physical Therapy Program

This intervention will include core stability training, stretching exercises, strengthening and facilitation exercises for the affected lower-limb muscles, postural reaction training and gait training. Materials and Equipment Used for Conventional Physical Therapy: These include therapeutic mats, Bobath treatment tables. exercise balls, wedges, rolls, parallel bars, a stepper, a balance board, and obstacles.

DEVICE

FES-Assisted Gait Training

FES-Assisted Gait Training Using the WalkAide® Foot-Drop Stimulator: During gait training, the WalkAide® device delivers functional electrical stimulation (FES) to help lift the foot during the swing phase of walking. The device is secured around the calf, with electrodes positioned near the head of the fibula to stimulate the common peroneal nerve and activate the ankle dorsiflexor muscles. An integrated tilt sensor detects the onset of the swing phase and automatically triggers electrical stimulation, while the stimulation parameters are adjusted to produce adequate ankle dorsiflexion and improve foot clearance during walking.

Inclusion Criteria: * Male adults aged 50-60 years. * Confirmed chronic post-stroke hemiplegia lasting more than six months, documented in medical records or confirmed by the treating physician, with MRI findings supporting the diagnosis as specified in the study protocol. * Lower-limb spasticity graded 1, 1+, or 2 on the Modified Ashworth Scale. * Ability to understand and follow instructions. * Absence of serious or recurrent medical complications, as determined by the treating physician. * Absence of significant hip or knee flexion contractures, Achilles tendon tightness, or major lower-limb rotational malalignment. * Intact common fibular (peroneal) nerve function and adequate function of the proximal lower-limb muscles required for the intervention. * Absence of other medical or neurological conditions that could substantially affect balance, apart from stroke-related impairments. * No concurrent treatment specifically intended to improve the affected lower-limb function during the study period. Exclusion Criteria: * Skin conditions or known allergies to adhesive tapes or materials used during the intervention. * Visual, auditory, or perceptual impairments that may interfere with understanding instructions or participating safely in the study. * A history of lower-limb surgery, as specified in the study protocol. * A history of seizures or epilepsy. * Botulinum toxin injections into the lower-limb muscles within the preceding six months or planned during the study period, or initiation or modification of antispasticity medication within the three months before baseline assessment, as specified in the protocol. * Radiographically confirmed hip pathology that may be aggravated by the intervention, a history of hip or knee surgery, or peripheral neuropathy that may affect treatment safety or outcomes. * Back disorders, sciatica, or spinal stenosis that may interfere with gait training or functional mobility. * An implanted pacemaker or other electronic device that may be incompatible with functional electrical stimulation (FES).

Locations (1)

Ehab Mohamed Abd El Kafy

Mecca, Mecca Region, Saudi Arabia