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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
30
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.
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.
g.tec medical engineering GmbH
Schiedlberg, Upper Austria, Austria
10 Meter Walk Test
The 10MWT assesses walking speed in meters per second over a short distance and is one of the most used to evaluate functional mobility, gait, and balance for lower limb therapy. This is a metric and continuous variable. The 10MWT is used for clinical purposes and in research. It supports the assessment of the degree of damage and describes the recovery of lower extremity after a stroke. Individuals walk 10 meters without assistance and the time is measured for the intermediate 6 meters to allow for acceleration and deceleration. Assistive devices can be used but should be kept consistent and documented from test to test. If physical assistance is required to walk, the 10MWT should not be performed. Patients will receive the following instructions: "Walk as fast as you can safely walk and stop when you reach the far mark."
Time frame: From enrollment to the end of treatment at 8 weeks
Timed Up and Go test
This test assesses the time that patient needs to get out of chair, walk 3 meters, turn around, walk back 3 meters, and sit down again. The increase in TUG score is consistent with the symptomatology of stroke manifested as muscle weakness and spasticity. Muscle weakness and spasticity are characterized by difficulty in generating appropriately timed and sufficient muscle force to accomplish a given functional task, which could explain the lengthened time score of TUG in subjects with stroke. This is a metric and continuous variable.
Time frame: From enrollment to the end of treatment at 8 weeks
Modified Ashworth Scale
The MAS assesses the spasticity in patients after the CNS damages. This is an ordinal scale with 6 levels. Score criteria: * 0 - No increase in muscle tone. * 1 - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension. * 1+ - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of motion (ROM). * 2 - More marked increase in muscle tone through most of the ROM but affected part(s) easily moved. * 3 - Considerable increase in muscle tone, passive movement difficult. * 4 - Affected part(s) rigid in flexion or extension. The test should not be performed more than three times for each joint (knee and ankle); If it would be done more than three times, the short-term effect of a stretch could influence the score.
Time frame: From enrollment to the end of treatment at 8 weeks
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