Efficacy and Safety of 6Degrees MyMove Interactive Virtual Reality Compared to Passive Virtual Re… (NCT07441798) | Clinical Trial Compass
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Efficacy and Safety of 6Degrees MyMove Interactive Virtual Reality Compared to Passive Virtual Reality in Subacute Stroke and Traumatic Brain Injury Rehabilitation: A Randomized Controlled Trial
Israel60 participantsStarted 2026-03-18
Plain-language summary
Stroke and traumatic brain injury frequently result in persistent upper and lower limb motor impairment. While conventional rehabilitation improves outcomes, patient adherence and training intensity remain limiting factors. Immersive virtual reality (VR)-based therapy may enhance neuroplasticity by delivering high-intensity, task-oriented motor practice with enriched sensory feedback.
This randomized controlled trial evaluates the efficacy and safety of the 6Degrees MyMove interactive VR system compared to passive VR exposure in individuals undergoing subacute inpatient rehabilitation after stroke or traumatic brain injury. Sixty participants will be randomized 1:1 to receive either interactive VR-based motor training or passive VR viewing, in addition to standard rehabilitation care, three times weekly for eight weeks.
The primary objective is to determine whether interactive VR leads to greater improvement in motor function compared to passive VR. Secondary outcomes include dexterity, gait speed, functional independence, psychological status, adherence, usability, and safety.
Who can participate
Age range40 Years
SexALL
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Inclusion criteria
✓. Time since neurological event: At least 2 weeks post-stroke or post-head injury.
✓. Motor impairment: Upper extremities: Presence of hemiparesis without complete paralysis. Participants receiving rehabilitation focused on functional transfer to the contralateral hand using compensatory or adaptive motor learning strategies will also be eligible. Lower extremities: Presence of partial voluntary movement sufficient to allow participation in rehabilitation training.
✓. Cognitive ability: Sufficient cognitive capacity to understand instructions and engage with VR-based training, as determined by the principal investigator and/or treating physician.
✓. Medical stability: Medically stable condition allowing participation in the training.
✓. Informed consent: Ability to provide written informed consent personally or via a legal guardian.
✓. Final eligibility will be determined by the principal investigator/ treating physician.
Exclusion criteria
✕. Severe cognitive or language impairment: Cognitive deficits or language comprehension impairments that prevent safe and meaningful participation.
✕. Neurological deficits interfering with VR: Severe hemispatial neglect or visual field deficits that interfere with VR use. Moderate neglect may be permitted at the investigator's discretion.