An interventional study of Conventional Physical Therapy Program and FES-Assisted Gait Training in Stroke, sponsored by Umm Al-Qura University. Not yet recruiting at 1 site in Saudi Arabia. Open to male participants aged 50 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Umm Al-Qura University · Not applicable, Interventional, and Treatment
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.
Stroke is a leading cause of long-term disability worldwide and represents a substantial health burden for survivors, their families, and healthcare systems. Although advances in acute stroke management have improved survival rates, many survivors experience persistent neurological impairments and activity limitations that can adversely affect their independence and quality of life. Motor dysfunction is among the most common consequences of stroke, particularly in individuals with hemiparesis, and frequently manifests as muscle weakness, impaired selective motor control, abnormal muscle tone, reduced postural stability, and gait disturbances. These impairments can compromise functional mobility, increase the risk of falls, restrict participation in activities of daily living, and limit social reintegration. Consequently, restoring safe and efficient mobility and improving health-related quality of life are major priorities in stroke rehabilitation.
Conventional approaches to improving mobility after stroke typically involve task-specific gait training, balance exercises, strengthening, and the use of assistive devices, such as canes, walkers, and ankle-foot orthoses (AFOs). Although these interventions can improve functional performance, their effectiveness may be limited by the severity of motor impairment, inadequate muscle activation, persistent abnormal movement patterns, and difficulties achieving sufficient repetition of functional movements. Functional electrical stimulation (FES) has emerged as an adjunctive rehabilitation approach that may address some of these limitations by delivering controlled electrical impulses to peripheral nerves to elicit contractions in the targeted skeletal muscles. In individuals with stroke, FES is commonly applied to facilitate muscle activation during functional activities, particularly to improve ankle dorsiflexion during the swing phase of gait in patients with foot drop. By supporting more appropriate muscle activation and movement timing, FES may contribute to improved foot clearance, gait performance, and functional mobility. Its application has also been investigated in other neurological conditions, including spinal cord injury and other disorders associated with impaired voluntary muscle control.
Despite the potential benefits of FES, its clinical implementation in stroke rehabilitation remains variable. This variation may reflect differences in patient characteristics, stimulation protocols, treatment duration, device design, and outcome measures, as well as inconsistencies in the reported magnitude and durability of treatment effects. In addition, equipment costs, technical complexity, the need for appropriate patient selection, and limited access to specialized rehabilitation services may restrict its routine use in clinical practice. Importantly, improvements in specific motor functions or gait parameters do not necessarily translate into greater independence in daily activities or better perceived quality of life. Therefore, evaluating both functional and patient-centered outcomes is essential to determine the broader clinical value of FES.
Accordingly, this study aims to investigate the effectiveness of functional electrical stimulation for foot-drop rehabilitation in improving functional mobility and health-related quality of life among individuals with chronic stroke. By examining changes in functional performance alongside quality-of-life outcomes, the study seeks to provide evidence regarding the potential contribution of FES to comprehensive stroke rehabilitation and its role in promoting greater independence and participation in everyday life.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 40 is below the median of 49 across 6,024 interventional studies indexed under Stroke.
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Exclusion Criteria:
Participants assigned to the control group will receive a conventional physical therapy program lasting 90 minutes per session. The session will consist of two 40-minute components, separated by a 10-minute rest period. The first component will include core stability training, stretching exercises, strengthening and facilitation exercises for the affected lower-limb muscles, and postural reaction training. The second component will focus on gait training. The conventional physical therapy program will be administered by therapists experienced in stroke rehabilitation. Treatment will be provided three times per week for eight consecutive weeks.
Other: Conventional Physical Therapy Program
Participants assigned to the experimental group will receive the same conventional physical therapy program as the control group, with the addition of FES-assisted gait training using the WalkAide® foot-drop stimulator. Each session will last 90 minutes and will consist of two 40-minute components separated by a 10-minute rest period. The first component will include core stability training, stretching exercises, strengthening and facilitation exercises for the affected lower-limb muscles, and postural reaction training. During the second component, participants will perform gait training with the WalkAide® device to deliver electrical stimulation to facilitate ankle dorsiflexion during walking. The intervention will be administered by physical therapists experienced in stroke rehabilitation, three times per week for eight consecutive weeks.
Other: Conventional Physical Therapy Program · Device: FES-Assisted Gait Training
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.
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.
Change in the gait parameter (stride length).
An electronic walkway that connected to a portable computer will be used to measure the following gait parameter: stride length (m).
Time frame: Data will be collected at baseline, and after 8 weeks (after finishing the treatment program).
Change in the gait parameter (stride time).
An electronic walkway that connected to a portable computer will be used to measure the following gait parameter: stride time (second).
Time frame: Data will be collected at baseline, and after 8 weeks (after finishing the treatment program).
Change in the gait parameter (velocity).
An electronic walkway that connected to a portable computer will be used to measure the following gait parameter: velocity (meter / second).
Time frame: Data will be collected at baseline, and after 8 weeks (after finishing the treatment program).
Change in the Overall Stability Index {percentage value (%)} for Limit of Stability Test (test that assess the change in balance ability)
The Biodex Balance System will be used to assess the change in the Overall Stability Index. This test involves measurement of overall directional control which represented as a percentage value (%). The higher scores will indicate better balance control.
Time frame: Data will be collected at baseline, and after 8 weeks (after finishing the treatment program).
Change in functional independence in activities of daily living, and quality of life will be assessed using the Barthel Index.
Change in functional independence in activities of daily living and quality of life, will be assessed using the Barthel Index. Higher scores indicate greater independence.
Time frame: Data will be collected at baseline, and after 8 weeks (after finishing the treatment program).
Change in the Overall Stability Index {Time of Control (seconds)} for Limit of Stability Test (test that assess the change in balance ability)
The Biodex Balance System will be used to assess the change in the Time of Control of the Limit of Stability Test. This test involves measurement of total time required to complete the test (seconds), improvement in this parameter requires minimizing the time recorded to complete the test.
Time frame: Data will be collected at baseline, and after 8 weeks (after finishing the treatment program).
The change in the six-minute walk test score.
The six-minute walk test (6MWT) will assess the distance that the participant's ability to walk for a total of six minutes on a hard, uneven surface. It has been used to determine exercise tolerance changes following interventions for healthy older adults.
Time frame: Data will be collected at baseline, and after 8 weeks (after finishing the treatment program).
Change in the score of fall risk test .
The Biodex Balance System will be used to assess changes in the Overall Stability Index (OSI) during the Fall Risk Test. The results for each participant will be recorded and compared with the age-specific normative data available in the device software for children.
Time frame: Data will be collected at baseline, and after 8 weeks (after finishing the treatment program).
Plan to share: Yes — - The data available is Case-by-case basis at the discretion of Primary Sponsor
Supporting information: Statistical analysis plan
Time frame: Start Date: Beginning one year following main results publication End Date: Ending two years following main results publication
Access criteria: Data can be obtained by the Principal Investigator. Email Address: emkafy@uqu.edu.sa
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Umm Al-Qura University