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NCT07537530: BrainSTEP

Gait Rehabilitation in Stroke Patients Using Functional Electrical Stimulation and Visual Feedback

Completed NA Last updated 17 April 2026
What this trial tests

NA trial testing recoveriX in Stroke in 30 participants. Completed in 2 April 2026.

Timeline
3 June 2025
Primary endpoint
2 April 2026
2 April 2026

Quick facts

Lead sponsorg.tec medical engineering GmbH
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment30
Start date3 June 2025
Primary completion2 April 2026
Estimated completion2 April 2026
Sites1 location across Austria

Drugs / interventions tested

Conditions studied

Sponsor

g.tec medical engineering GmbH

Who can join

18 and older, any sex, with Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07537530.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing