Gait Rehabilitation in Stroke Patients Using Functional Electrical Stimulation and Visual Feedback (NCT07537530) | Clinical Trial Compass
CompletedNot Applicable
Gait Rehabilitation in Stroke Patients Using Functional Electrical Stimulation and Visual Feedback
Austria30 participantsStarted 2025-06-03
Plain-language summary
recoveriX PRO system is a Brain-Computer Interface (BCI) device that combines Motor Imagination (MI), with Functional Electrical Stimulation (FES) and Virtual Reality (VR) as feedback devices. The user wears an electroencephalography (EEG) cap that registers the neural activity during the mental practice. This system allows the user to control the feedback devices (FES +VR) with the MI.
The goal of this clinical trial is to know the safety and clinical effectiveness of recoveriX-based treatment for improving gait functions in stroke patients. Researchers will compare the functional results obtained by recoveriX system, to the standard treatment based in FES + VR + MI without monitoring the EEG activity.
The questions to answer are:
1. Will stroke patients who undergo recoveriX therapy significantly improve their gait ability?
2. Is the functional improvement (gait speed) achieved with the BCI treatment superior to the standard MI+FES+VR treatment?
3. Is the recoveriX-based therapy as safe as the standard treatment?
Participants will have to perform a complete assessment to evaluate their functionality before and after the intervention (motor skills, walking ability, impact of the disease in daily living activities).
Patients in the BCI group will receive 25 sessions (3 sessions per week) of BCI training with FES and VR feedback (24 sessions in total).
Patients in the control group will receive 25 sessions (3 sessions per week) of FES + VR therapy. Patients in the control group will receive the same instructions as the experimental but will not wear the EEG cap.
Who can participate
Age range
18 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:
* 6-months or more post stroke
* With a restriction of the lower extremities preventing the persons from activities of daily life
* Participants must be German speaking.
* Demonstrate intact cognition to provide informed consent and follow instructions.
* Be able to perform TUG and 10MWT (3 times).
Exclusion Criteria:
* Debilitating conditions or vision impairment that would impede full participation in the study.
* Other neurological conditions affecting the motor system or the compliance to the therapy (for example Polyneuropathy or Musculoskeletal Diseases).
* Uncontrolled epilepsy or seizures
* Significant circulatory disturbances of the stimulated extremities
* Inability to independently maintain the seated position (without assistance) for about 60 minutes.
* Pregnant
* Active or passive implanted medical devices such as pacemakers which do not allow the use of FES.
* Implanted metallic fragments in the upper and lower extremities which can limit the use of FES.
* Under the influence of anesthesia or similar medication.
* With fractures or lesions in the extremity to be stimulated.
* Inadequate control of a BCI system.
* Sensory disorders which can significantly affect the patient's ability to feel pain and to react to unsuitable proprioceptive stimuli.
* Botulinum toxin treatment of his/her paretic lower limb during this study
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
10 Meter Walk Test
Timeframe: From enrollment to the end of treatment at 8 weeks