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

NCT07441798 | Not Yet Recruiting DMC

• 1 other identifier: 00006-26-RRH
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

TBI Traumatic Brain Injury; CVA (Cerebrovascular Accident)

Keywords

Virtual Reality Therapy; Upper Limb Rehabilitation; Stroke Rehabilitation; Fugl-Meyer Assessment; Neurorehabilitation; Wearable Motion Sensors

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Assessment - Upper Extremity (FMA-UE)

  A standardized, stroke-specific measure of upper-limb motor impairment assessing movement, coordination, and reflex activity. Scores range from 0 to 66, with higher scores indicating better motor function.

  Week 8 (Immediate post-intervention), 1 month follow-up, and 3 months follow-up

Secondary Outcomes (4)

• Finger Tapping Test

  Week 8 (Immediate post-intervention), 1 month follow-up, and 3 months follow-up

• Box and Blocks Test (BBT)

  Week 8 (Immediate post-intervention), 1 month follow-up, and 3 months follow-up

• 10-Meter Walk Test (10MWT)

  Immediate post-intervention (8 weeks)

• Five Times Sit-to-Stand Test (5xSTS)

  Immediate post-intervention (8 weeks)

Other Outcomes (2)

• EQ-5D-5L

  Immediate post-intervention (8 weeks)

• System Usability Scale (SUS)

  Immediate post-intervention (8 weeks)

Study Arms (2)

MyMove/VR system

EXPERIMENTAL

The treatment system consists of two lightweight MyMove bands and Virtual-Reality (VR) gear. Proprietary software and content allow tracking of performance in real-time, with feedback to both the patient and treating - personnel.

Device: MyMove/VR system

Passive VR

ACTIVE COMPARATOR

Passive VR involves the use of a head-mounted display to present immersive audiovisual content (e.g., movies, 360-degree videos, or virtual environments) without requiring active engagement, task performance, or interaction with the virtual environment.

Device: Passive VR

Interventions

MyMove/VR system DEVICE

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.

MyMove/VR system

Passive VR DEVICE

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.

Passive VR

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Reuth Rehabilitation Hospital: lead
• 6Degrees LTD: collaborator

Study Sites (1)

Reuth Rehabilitation Hospital - Tel Aviv

Tel Aviv, 6772830, Israel

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic; Stroke

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Rachel Dankner, Prof.

CONTACT

+972-3-6383610; rachel.dankner@reuth.org.il

Marina Brozgol

CONTACT

+972-3-6383610; marina.brozgol@reuth.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 2, 2026
• Study Start: March 18, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 2, 2026

Record last verified: 2026-02

Locations

IL (1)