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Parkinson's Disease Rehabilitation Using Neurofeedback With Functional Electrical Stimulation and Virtual Reality Feedback for Lower Extremities
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 motor functions in Parkinson's Disease 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 Parkinson's patients who undergo recoveriX therapy significantly improve their motor functions? 2. Is the functional improvement 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, fatigue, impact of the disease in daily living activities). Patients in the BCI group will receive 6 sessions per week during 4 weeks of BCI training with FES and VR feedback (24 sessions in total). Patients in the control group receive 6 sessions of FES + VR therapy per week for 4 weeks (24 sessions in total). Patients in the control group will receive the same instructions as the experimental but will not wear the EEG cap.
Age
40 - 80 years
Sex
ALL
Healthy Volunteers
No
g.tec medical engineering GmbH
Schiedlberg, Upper Austria, Austria
Start Date
December 9, 2024
Primary Completion Date
August 1, 2027
Completion Date
August 1, 2027
Last Updated
May 9, 2025
30
ESTIMATED participants
Brain-Computer Interface with FES and VR
DEVICE
Motor imagery with Functional Electrical Stimulation and Virtual Reality feedback
DEVICE
Lead Sponsor
g.tec medical engineering GmbH
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06113640