TBI Traumatic Brain InjuryNCT07441798
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
A study testing MyMove/VR system and Passive VR in people with TBI Traumatic Brain Injury and CVA (Cerebrovascular Accident), run by Reuth Rehabilitation Hospital at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- TBI Traumatic Brain Injury, CVA (Cerebrovascular Accident)
- What is being tested?
- MyMove/VR system and Passive VR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 18 Mar 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site
Reuth Rehabilitation Hospital - Tel Aviv
Tel Aviv, 6772830
Marina Brozgol, +972-3-6383610, marina.brozgol@reuth.org.il
Rachel Dankner, Prof.
About this study
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.
- Being tested
- MyMove/VR system, Passive VR
- Keywords
- Virtual Reality Therapy, Upper Limb Rehabilitation, Stroke Rehabilitation, Fugl-Meyer Assessment, Neurorehabilitation, Wearable Motion Sensors
- Medical subject headings
- Brain Injuries, Traumatic, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyMove/VR systemDevice
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 VRDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Passive VR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 8 (Immediate post-intervention), 1 month follow-up, and 3 months follow-up
Secondary outcomes (4)
Finger Tapping Test
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.
Measured: Week 8 (Immediate post-intervention), 1 month follow-up, and 3 months follow-up
Box and Blocks Test (BBT)
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.
Measured: Week 8 (Immediate post-intervention), 1 month follow-up, and 3 months follow-up
10-Meter Walk Test (10MWT)
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.
Measured: Immediate post-intervention (8 weeks)
Five Times Sit-to-Stand Test (5xSTS)
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.
Measured: Immediate post-intervention (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start18 Mar 2026 (estimated)
- Primary completion31 May 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for TBI Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reuth Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- 6Degrees LTD
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07441798
- Sponsor's protocol ID
- 00006-26-RRH
- Status last verified
- Feb 2026
- First submitted
- 24 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 38437102Ciullo 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.
PubMed 41270979Bargeri 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.
PubMed 37745019
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07441798
- Acronym / sponsor ID
- 00006-26-RRH
- Keywords
- Virtual Reality Therapy, Upper Limb Rehabilitation, Stroke Rehabilitation, Fugl-Meyer Assessment, Neurorehabilitation, Wearable Motion Sensors
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Reuth Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- 6Degrees LTD
- Study start
- 18 Mar 2026 (estimated)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MyMove/VR system | Experimental | Device: MyMove/VR systemThe 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. |
| Passive VR | Active comparator | Device: Passive VRPassive 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyMove/VR systemDuring 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 | MyMove/VR system |
| Passive VRParticipants 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. | Device | Passive VR |
Primary outcome
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.
4 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Background: PubMed 38437102Curiel 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.
- Background: PubMed 41270979Ciullo 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.
- Background: PubMed 37745019Bargeri 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyMove/VR system and Passive VR in people with TBI Traumatic Brain Injury and CVA (Cerebrovascular Accident), run by Reuth Rehabilitation Hospital at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Dankner, Prof. (+972-3-6383610, rachel.dankner@reuth.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment - Upper Extremity (FMA-UE) (time frame: Week 8 (Immediate post-intervention), 1 month follow-up, and 3 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07441798, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.