FES-assisted Gait Training for Incomplete Spinal Cord Injury (NCT07645144) | Clinical Trial Compass
By InvitationNot Applicable
FES-assisted Gait Training for Incomplete Spinal Cord Injury
Netherlands30 participantsStarted 2026-02-09
Plain-language summary
Spinal cord injuries (SCI) impair neural communication, leading to difficulties in walking due to muscle weakness, altered reflexes, and impaired muscle activation below the injury. Functional electrical stimulation (FES) has been shown to enhance voluntary control, strength, and walking performance when used during gait training. This study aims to assess whether the FES yields superior improvements in walking ability compared to conventional gait training without stimulation.
Who can participate
Age range
17 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Have a non-progressive chronic (\>1 yrs) incomplete SCI between C4 and T12 with an ASIA score of C or D.
* Be at least 18 years of age.
* Be able to take some steps (with assistive devices or in the bridge).
* As part of the inclusion process, responsiveness to electrical stimulation will be assessed using a Compex electrical stimulator (Compex SP 4.0; Compex Medical SA, Switzerland) to ensure potential participant's respond well to ES, and to ensure that the sensitivity threshold is not reached before motor response in all target muscles.
Exclusion Criteria:
* Flaccid paralysis.
* Musculoskeletal dysfunction, uncured fractures, contractures, pressure injuries, or infections that could impede the intended training.
* Botox injections in the lower extremities during the last six months.
* Women who are (planning to get) pregnant during the study period.
* Implanted neurostimulator or stimulator of any kind that can have an influence on the safe use of ES.
* Pacemaker, or other device, present in the body that prevents the safe use of ES.
* Inability to communicate well or have cognitive disorders.
* Currently being enrolled in another training study or participated in a training study in the previous six months.
* Having an illness that has a high chance of preventing them to be able to perform the training at a sufficient frequency.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
walking speed
Timeframe: From enrollment to the end of study at 33 weeks