StrokeBrainSTEPNCT07537530
Gait Rehabilitation in Stroke Patients Using Functional Electrical Stimulation and Visual Feedback
A study testing recoveriX in people with Stroke, run by g.tec medical engineering GmbH at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- recoveriX
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- 3 Jun 2025to 2 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 6-months or more post stroke
- With a restriction of the lower extremities preventing the persons from activities of daily life
- Participants must be German speaking.
- Demonstrate intact cognition to provide informed consent and follow instructions.
- Be able to perform TUG and 10MWT (3 times).
Who cannot join
- Debilitating conditions or vision impairment that would impede full participation in the study.
- Other neurological conditions affecting the motor system or the compliance to the therapy (for example Polyneuropathy or Musculoskeletal Diseases).
- Uncontrolled epilepsy or seizures
- Significant circulatory disturbances of the stimulated extremities
- Inability to independently maintain the seated position (without assistance) for about 60 minutes.
- Pregnant
Show all 13Show fewer
- Active or passive implanted medical devices such as pacemakers which do not allow the use of FES.
- Implanted metallic fragments in the upper and lower extremities which can limit the use of FES.
- Under the influence of anesthesia or similar medication.
- With fractures or lesions in the extremity to be stimulated.
- Inadequate control of a BCI system.
- Sensory disorders which can significantly affect the patient's ability to feel pain and to react to unsuitable proprioceptive stimuli.
- Botulinum toxin treatment of his/her paretic lower limb during this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Pilot Study of Gait Rehabilitation in Stroke Patients Using Functional Electrical Stimulation and Visual Feedback
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.
Read more
The questions to answer are:
- Will stroke patients who undergo recoveriX therapy significantly improve their gait ability?
- Is the functional improvement (gait speed) achieved with the BCI treatment superior to the standard MI+FES+VR treatment?
- 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.
- Conditions
- Stroke
- Being tested
- recoveriX, Control
- Keywords
- Brain-Computer Interface, Neurofeedback, EEG feedback, Electrical Stimulation Therapy, Virtual reality
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recoveriXDevice
Also called Brain-Computer Interface with FES and VR
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.
ControlDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| BCI | Experimental | Patients in the BCI group will receive 25 sessions (3 times per week) of BCI training with FES and VR feedback. Receives: Device: recoveriX |
| 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. Receives: Device: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start3 Jun 2025
- Primary completion2 Apr 2026
- Study completion2 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- g.tec medical engineering GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537530
- Sponsor's protocol ID
- 1300/2024
- Other IDs
- 104215020
- Acronym
- BrainSTEP
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37920297Sebastian-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.
PubMed 33192277Sebastian-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.
PubMed 32733182Sieghartsleitner 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.
PubMed 38500488de 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.
PubMed 32973435
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Pilot Study of Gait Rehabilitation in Stroke Patients Using Functional Electrical Stimulation and Visual Feedback
- ClinicalTrials.gov ID
- NCT07537530
- Acronym / sponsor ID
- BrainSTEP / 1300/2024
- Conditions
- Stroke
- Keywords
- Brain-Computer Interface, Neurofeedback, EEG feedback, Electrical Stimulation Therapy, Virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- g.tec medical engineering GmbHIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2025 (actual)
- Primary completion
- 2 Apr 2026 (actual)
- Study completion
- 2 Apr 2026 (actual)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Will stroke patients who undergo recoveriX therapy significantly improve their gait ability?
- Is the functional improvement (gait speed) achieved with the BCI treatment superior to the standard MI+FES+VR treatment?
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BCI | Experimental | Device: recoveriXPatients in the BCI group will receive 25 sessions (3 times per week) of BCI training with FES and VR feedback. |
| Control | Sham comparator | Device: ControlPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 6-months or more post stroke
- With a restriction of the lower extremities preventing the persons from activities of daily life
- Participants must be German speaking.
- Demonstrate intact cognition to provide informed consent and follow instructions.
- Be able to perform TUG and 10MWT (3 times).
Key exclusion criteria (13 listed)
- Debilitating conditions or vision impairment that would impede full participation in the study.
- Other neurological conditions affecting the motor system or the compliance to the therapy (for example Polyneuropathy or Musculoskeletal Diseases).
- Uncontrolled epilepsy or seizures
- Significant circulatory disturbances of the stimulated extremities
- Inability to independently maintain the seated position (without assistance) for about 60 minutes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| recoveriXAlso: Brain-Computer Interface with FES and VRThe 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. | Device | BCI |
| ControlThe 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. | Device | Control |
Primary outcome
10 Meter Walk Test
Time frame: From enrollment to the end of treatment at 8 weeks
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."
2 secondary outcomes
Timed Up and Go test
Time frame: From enrollment to the end of treatment at 8 weeks
Modified Ashworth Scale
Time frame: From enrollment to the end of treatment at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Background: PubMed 37920297Sebastian-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.
- Background: PubMed 33192277Sebastian-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.
- Background: PubMed 32733182Sebastian-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.
- Background: PubMed 38500488Sieghartsleitner 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.
- Background: PubMed 32973435de 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing recoveriX in people with Stroke, run by g.tec medical engineering GmbH at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10 Meter Walk Test (time frame: From enrollment to the end of treatment at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07537530, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.