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

February 24, 2026 updated by: Reuth Rehabilitation Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Tel Aviv, Israel, 6772830
        • Reuth Rehabilitation Hospital - Tel Aviv
        • Contact:
        • Principal Investigator:
          • Rachel Dankner, Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Time since neurological event: At least 2 weeks post-stroke or post-head injury.
  2. 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.
  3. Cognitive ability: Sufficient cognitive capacity to understand instructions and engage with VR-based training, as determined by the principal investigator and/or treating physician.
  4. Medical stability: Medically stable condition allowing participation in the training.
  5. Informed consent: Ability to provide written informed consent personally or via a legal guardian.
  6. Final eligibility will be determined by the principal investigator/ treating physician.

Exclusion Criteria:

  1. Severe cognitive or language impairment: Cognitive deficits or language comprehension impairments that prevent safe and meaningful participation.
  2. 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.

  3. Medical contraindications:

    • Uncontrolled epilepsy
    • Severe vestibular or vertigo disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MyMove/VR system
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
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.
Active Comparator: Passive VR
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Assessment - Upper Extremity (FMA-UE)
Time Frame: Week 8 (Immediate post-intervention), 1 month follow-up, and 3 months follow-up
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Finger Tapping Test
Time Frame: Week 8 (Immediate post-intervention), 1 month follow-up, and 3 months follow-up
A performance-based assessment of upper-limb motor speed and neuromotor control. Participants are instructed to tap a key or surface as rapidly as possible with the index finger over a fixed time interval. The total number of taps is recorded, with higher scores reflecting better motor speed and coordination.
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
A standardized measure of gross manual dexterity in which participants are instructed to transfer as many blocks as possible, one at a time, from one compartment of a box to another within 60 seconds. The total number of blocks successfully transferred is recorded. Higher scores indicate better manual dexterity.
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)
A performance-based measure of gait speed in which participants are instructed to walk a distance of 10 meters at a comfortable and safe pace. Walking speed is calculated in meters per second (m/s). Higher gait speed values indicate better functional mobility.
Immediate post-intervention (8 weeks)
Five Times Sit-to-Stand Test (5xSTS)
Time Frame: Immediate post-intervention (8 weeks)
A performance-based measure of lower-limb strength and functional mobility in which participants are instructed to rise from a seated position to standing and return to sitting five consecutive times as quickly and safely as possible. The total time required to complete the task is recorded in seconds. Lower completion times indicate better lower-limb function.
Immediate post-intervention (8 weeks)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
EQ-5D-5L
Time Frame: Immediate post-intervention (8 weeks)
A widely used, validated patient-reported measure of health-related quality of life assessing five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain is rated on five levels of severity (no problems to extreme problems). Responses are converted into a health utility index score, typically ranging from values below 0 (worse than death) to 1 (perfect health), with higher scores indicating better health status. An accompanying visual analog scale (EQ-VAS; 0-100) captures participants' self-rated overall health.
Immediate post-intervention (8 weeks)
System Usability Scale (SUS)
Time Frame: Immediate post-intervention (8 weeks)
A 10-item questionnaire assessing perceived usability of a system or technology. Each item is rated on a 5-point Likert scale (strongly disagree to strongly agree). Responses are converted to a total score ranging from 0 to 100, with higher scores indicating better perceived usability.
Immediate post-intervention (8 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Reuth Rehabilitation Hospital

Collaborators

6Degrees LTD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 18, 2026

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

February 24, 2026

First Submitted That Met QC Criteria

February 24, 2026

First Posted (Actual)

March 2, 2026

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00006-26-RRH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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