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Gait Rehabilitation in Stroke Patients Using Functional Electrical Stimulation and Visual Feedback

NCT07537530 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-04-17

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

recoveriX

The intervention utilizes the recoveriX PRO system. This is a neurofeedback therapy device that combines Brain-Computer Interface based motor imagery, functional electrical stimulation (FES), and virtual reality (VR). This approach enables participants to engage in motor imagery exercises while receiving real-time feedback based on neural signals. Participants will complete a total of 25 recoveriX sessions, scheduled at 3 sessions per week, with each session lasting 1 hour.

DEVICE

Control

The participants will train the Motor Imagination (MI) combined with Functional Electrical Stimulation (FES) and Virtual Reality (VR) feedback. Feedback provided to the patients will not be linked to the neural signals. The amount of stimulation delivered by the feedback devices (FES and VR) will be similar to the experimental group.

Sponsors & Collaborators

  • g.tec medical engineering GmbH

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-03
Primary Completion
2026-04-02
Completion
2026-04-02

Countries

  • Austria

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07537530 on ClinicalTrials.gov