Improve walking and leg function

Trial ID
NCT06690931
Official Title
Parkinson's Disease Rehabilitation Using Neurofeedback With Functional Electrical Stimulation and Virtual Reality Feedback for Lower Extremities
Goal
Improve walking and leg function
Phase
NA
Status
RECRUITING
Sponsor
g.tec medical engineering GmbH
Study Type
INTERVENTIONAL
Enrollment
30 participants
Conditions
Parkinson Disease
Interventions
Brain-Computer Interface with FES and VR, Motor imagery with Functional Electrical Stimulation and Virtual Reality feedback

Plain-Language Summary

The trial aims to improve walking, balance, and lower limb function in people with Parkinson's by retraining the brain-to-muscle connection that helps you move more smoothly. It uses a brain-computer interface to detect imagined leg movements, triggers small electrical pulses to the leg muscles with functional electrical stimulation, and gives real-time virtual reality feedback so your brain practices the intended movement while the muscles actually activate. The program is a rehabilitation approach used while you stay on your usual, stable Parkinson's medications, not a drug treatment; it cannot be used by people with implanted devices like pacemakers or metal fragments that make FES unsafe. They're enrolling people aged 40 to 80 with Parkinson's at Hoehn and Yahr stages 1 to 3 who can walk independently, have stable meds and neurological status, and do not have major comorbidities, severe depression, uncontrolled diabetes, unpredictable motor fluctuations, pregnancy, or other barriers to using a BCI or FES.

Locations

  • g.tec medical engineering GmbH, Schiedlberg, Upper Austria, Austria

Frequently Asked Questions

What is this trial testing?
This trial is studying Brain-Computer Interface with FES and VR. The trial aims to improve walking, balance, and lower limb function in people with Parkinson's by retraining the brain-to-muscle connection that helps you move more smoothly. It uses a brain-computer interface to detect imagined leg movements, triggers small electrical pulses to the leg muscles with functional electrical stimulation, and gives real-time virtual reality feedback so your brain practices the intended movement while the muscles actually activate. The program is a rehabilitation approach used while you stay on your usual, stable Parkinson's medications, not a drug treatment; it cannot be used by people with implanted devices like pacemakers or metal fragments that make FES unsafe. They're enrolling people aged 40 to 80 with Parkinson's at Hoehn and Yahr stages 1 to 3 who can walk independently, have stable meds and neurological status, and do not have major comorbidities, severe depression, uncontrolled diabetes, unpredictable motor fluctuations, pregnancy, or other barriers to using a BCI or FES.
Who can participate?
Participants must be between 40 Years and 80 Years.
Where is this trial located?
This trial is recruiting at 1 location.
Does it cost anything to join?
No. There is no cost to participate. Study-related care and treatment are provided at no charge.
How long does the trial last?
This trial is estimated to last approximately 2 years and 8 months.

View on ClinicalTrials.gov