Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 104215020 | Other Identifier | Austrian Federal Office for Safety in Health Care |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BCI | Experimental | Patients in the BCI group will receive 25 sessions (3 times per week) of BCI training with FES and VR feedback. |
|
| Control | Sham Comparator | Patients in the control group receive 25 sessions (3 times per week) of FES and VR therapy. Patients in the control group will receive the same instructions as the experimental but will not wear the EEG cap. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| recoveriX | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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." | From enrollment to the end of treatment at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| g.tec medical engineering GmbH | Schiedlberg | Upper Austria | 4521 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37920297 | Background | Sebastian-Romagosa M, Cho W, Ortner R, Sieghartsleitner S, Von Oertzen TJ, Kamada K, Laureys S, Allison BZ, Guger C. Brain-computer interface treatment for gait rehabilitation in stroke patients. Front Neurosci. 2023 Oct 18;17:1256077. doi: 10.3389/fnins.2023.1256077. eCollection 2023. | |
| 33192277 | Background |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D062207 | Brain-Computer Interfaces |
| ID | Term |
|---|---|
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Control | Device | 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. |
|
| 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:
| From enrollment to the end of treatment at 8 weeks |
| Sebastian-Romagosa M, Cho W, Ortner R, Murovec N, Von Oertzen T, Kamada K, Allison BZ, Guger C. Brain Computer Interface Treatment for Motor Rehabilitation of Upper Extremity of Stroke Patients-A Feasibility Study. Front Neurosci. 2020 Oct 21;14:591435. doi: 10.3389/fnins.2020.591435. eCollection 2020. |
| 32733182 | Background | Sebastian-Romagosa M, Udina E, Ortner R, Dinares-Ferran J, Cho W, Murovec N, Matencio-Peralba C, Sieghartsleitner S, Allison BZ, Guger C. EEG Biomarkers Related With the Functional State of Stroke Patients. Front Neurosci. 2020 Jul 7;14:582. doi: 10.3389/fnins.2020.00582. eCollection 2020. |
| 38500488 | Background | Sieghartsleitner S, Sebastian-Romagosa M, Cho W, Grunwald J, Ortner R, Scharinger J, Kamada K, Guger C. Upper extremity training followed by lower extremity training with a brain-computer interface rehabilitation system. Front Neurosci. 2024 Mar 4;18:1346607. doi: 10.3389/fnins.2024.1346607. eCollection 2024. |
| 32973435 | Background | de Castro-Cros M, Sebastian-Romagosa M, Rodriguez-Serrano J, Opisso E, Ochoa M, Ortner R, Guger C, Tost D. Effects of Gamification in BCI Functional Rehabilitation. Front Neurosci. 2020 Aug 21;14:882. doi: 10.3389/fnins.2020.00882. eCollection 2020. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |