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NCT Number: NCT07441798

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

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.

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Key information

Conditions

TBI Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic CVA (Cerebrovascular Accident) Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Craniocerebral Trauma Nervous System Diseases Stroke Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Reuth Rehabilitation Hospital - Tel Aviv

Tel Aviv, 6772830, Israel

Location contact

Marina Brozgol

CONTACT

[email protected]

+972-3-6383610

Rachel Dankner, Prof.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Other outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marina Brozgol

CONTACT

[email protected]

+972-3-6383610

Rachel Dankner, Prof.

CONTACT

[email protected]

+972-3-6383610

Sponsors and collaborators

Lead sponsor

Reuth Rehabilitation Hospital

Other

Collaborators

  • 6Degrees LTD

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 2, 2026
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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