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

Overview

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.

Interventions

• Device MyMove/VR system
  During each session, participants will engage in goal-directed motor exercises within an immersive VR environment delivered through a head-mounted display. Tasks are designed to promote range of motion, coordination, motor control, and functional movement. The system provides real-time visual and auditory feedback and adapts task difficulty based on individual performance and motor capacity.
• Device Passive VR
  Participants in the control arm will receive immersive virtual reality exposure using a head-mounted display. The content will include movies, 360-degree videos, or virtual environments designed to provide audiovisual immersion without requiring active motor engagement or task performance.

Primary outcome measures

• Fugl-Meyer Assessment - Upper Extremity (FMA-UE) [Time frame: Week 8 (Immediate post-intervention), 1 month follow-up, and 3 months follow-up]

Secondary outcome measures (4)

• Finger Tapping Test [Time frame: Week 8 (Immediate post-intervention), 1 month follow-up, and 3 months follow-up]
• Box and Blocks Test (BBT) [Time frame: Week 8 (Immediate post-intervention), 1 month follow-up, and 3 months follow-up]
• 10-Meter Walk Test (10MWT) [Time frame: Immediate post-intervention (8 weeks)]
• Five Times Sit-to-Stand Test (5xSTS) [Time frame: Immediate post-intervention (8 weeks)]

Eligibility criteria

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.
• Medical contraindications:

• Uncontrolled epilepsy
• Severe vestibular or vertigo disorders

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Israel · 1 center

• Reuth Rehabilitation Hospital - Tel Aviv — Tel Aviv

Publications

• Curiel RC, Nakamura T, Kuzuoka H, Kanaya T, Prahm C, Matsumoto K. Virtual Reality Self Co-Embodiment: An Alternative to Mirror Therapy for Post-Stroke Upper Limb Rehabilitation. IEEE Trans Vis Comput Graph. 2024 May;30(5):2390-2399. doi: 10.1109/TVCG.2024.3372035. Epub 2024 Apr 19. PMID 38437102
• Ciullo G, Bozzetti F, Ziccarelli S, Fogassi L, Errante A. Neurophysiological mechanisms underlying action observation treatment for upper limb stroke rehabilitation: A mini-review. Neurosci Biobehav Rev. 2026 Jan;180:106484. doi: 10.1016/j.neubiorev.2025.106484. Epub 2025 Nov 19. PMID 41270979
• Bargeri S, Scalea S, Agosta F, Banfi G, Corbetta D, Filippi M, Sarasso E, Turolla A, Castellini G, Gianola S. Effectiveness and safety of virtual reality rehabilitation after stroke: an overview of systematic reviews. EClinicalMedicine. 2023 Sep 14;64:102220. doi: 10.1016/j.eclinm.2023.102220. eCollection 2023 Oct. PMID 37745019

Identifiers

NCT: NCT07441798 · 00006-26-RRH

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗