Clinical Research Directory

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

Sponsor: g.tec medical engineering GmbH

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.

Official title: A Randomized Controlled Pilot Study of Gait Rehabilitation in Stroke Patients Using Functional Electrical Stimulation and Visual Feedback

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