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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

NCT07441798 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-03-02

No results posted yet for this study

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)

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.

Sponsors & Collaborators

  • 6Degrees LTD

    collaborator INDUSTRY

  • Reuth Rehabilitation Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-18
Primary Completion
2028-05-31
Completion
2028-12-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07441798 on ClinicalTrials.gov