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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorReuth Rehabilitation Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Uncontrolled epilepsy

Severe vestibular or vertigo disorders

Trial design

Treatments tested in this trial

  • MyMove/VR system
  • Passive VR

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators