StrokeNCT06963645
Augmented Reality-based Telerehabilitation Platform for Patients With Stroke
A study testing AR rehabilitation app in people with Stroke, run by Stanford University at 1 site in United States.
Trial summary
The study is to 1) determine the feasibility of the use of our augmented reality (AR) rehabilitation program, including its preliminary efficacy, 2) determine the feasibility of obtaining an augmented reality assessment based on the Fugl-Meyer Assessment - Upper Extremity (FMA-UE). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- AR rehabilitation app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2025to Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- ≥3 months post ischemic or hemorrhagic stroke
- Upper extremity deficit with an FMA-UE score between 20-50
- Able to operate the AR device independently or with the help of a caregiver
- Sufficiently proficient in the English language to follow instructions from Reia
Who cannot join
- History of developmental, neurological or psychological impairment leading to functional disability
- Vision or visual field impairment that interferes with the use of the AR headset
- Severe photosensitivity that makes use of the AR headset uncomfortable
- History of visually provoked seizures
- Hearing aids
- Cardiac pacemaker
- Implantable cardioverter-defibrillator (ICD)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Augmented Reality-based Telerehabilitation Platform for Patients With Stroke: A Feasibility Study
The study is to 1) determine the feasibility of the use of our augmented reality (AR) rehabilitation program, including its preliminary efficacy, 2) determine the feasibility of obtaining an augmented reality assessment based on the Fugl-Meyer Assessment - Upper Extremity (FMA-UE).
- Conditions
- Stroke
- Being tested
- AR rehabilitation app
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AR rehabilitation appDevice
Also called Reia
The intervention will consist of an 8-week home rehabilitation program during which the participant will have 1) a total of 7 weekly remote video visits with a therapist and 2) daily at-home exercises using the AR headset with rehabilitation app, done independently.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation Group | Experimental | Participants will use a mobile medical device in a augmented reality (AR) headset for 30 minutes daily to support their rehabilitation process after stroke by completing assessments and training programs. Receives: Device: AR rehabilitation app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
Percentage of days during the 8-week intervention period that a patient completes their 30-minute rehabilitation session.
Measured: 8 weeks
Percentage of participants who successfully complete the vFMA-UE
Feasibility of obtaining the Fugl-Meyer Assessment - Upper Extremity (vFMA-UE) unsupervised, described by the percentage of participants who successfully complete the vFMA-UE at home on day 70, among patients who attempted to do the unsupervised vFMA-UE.
Measured: Day 70
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study startJun 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Why it stopped: Study did not receive funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Berkeley
- Responsible party
- Principal investigator, Maarten Lansberg, Stanford University
- Investigators
- Maarten Lansberg, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06963645
- Sponsor's protocol ID
- 80062
- Status last verified
- Apr 2026
- First submitted
- 30 Apr 2025
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmented Reality-based Telerehabilitation Platform for Patients With Stroke: A Feasibility Study
- ClinicalTrials.gov ID
- NCT06963645
- Acronym / sponsor ID
- 80062
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study did not receive funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- University of California, Berkeley
- Study start
- Jun 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 9 May 2025 (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.
The study is to 1) determine the feasibility of the use of our augmented reality (AR) rehabilitation program, including its preliminary efficacy, 2) determine the feasibility of obtaining an augmented reality assessment based on the Fugl-Meyer Assessment - Upper Extremity (FMA-UE).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation Group | Experimental | Device: AR rehabilitation appParticipants will use a mobile medical device in a augmented reality (AR) headset for 30 minutes daily to support their rehabilitation process after stroke by completing assessments and training programs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years or older
- ≥3 months post ischemic or hemorrhagic stroke
- Upper extremity deficit with an FMA-UE score between 20-50
- Able to operate the AR device independently or with the help of a caregiver
- Sufficiently proficient in the English language to follow instructions from Reia
Key exclusion criteria (7 listed)
- History of developmental, neurological or psychological impairment leading to functional disability
- Vision or visual field impairment that interferes with the use of the AR headset
- Severe photosensitivity that makes use of the AR headset uncomfortable
- History of visually provoked seizures
- Hearing aids
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 |
|---|---|---|
| AR rehabilitation appAlso: ReiaThe intervention will consist of an 8-week home rehabilitation program during which the participant will have 1) a total of 7 weekly remote video visits with a therapist and 2) daily at-home exercises using the AR headset with rehabilitation app, done independently. | Device | Telerehabilitation Group |
Primary outcome
Adherence
Time frame: 8 weeks
Percentage of days during the 8-week intervention period that a patient completes their 30-minute rehabilitation session.
Percentage of participants who successfully complete the vFMA-UE
Time frame: Day 70
Feasibility of obtaining the Fugl-Meyer Assessment - Upper Extremity (vFMA-UE) unsupervised, described by the percentage of participants who successfully complete the vFMA-UE at home on day 70, among patients who attempted to do the unsupervised vFMA-UE.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Development, Validation and Normative Data of the Italian Battery for the Recognition of Famous Faces (FAME)
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Long-Term Clinical, Health Economic, and Process Evaluation of Intensive Technology-Integrated Motor Rehabilitation in Chronic Neurological Conditions (INTeRAcT-bis)
Stroke, Spinal Cord Injuries (SCI)
Not yet recruitingPhase 2
Rimonabant for Improving Walking Ability in Patients With Chronic Stroke
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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. This study is not recruiting at the moment.
Maarten Lansberg, MD, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AR rehabilitation app in people with Stroke, run by Stanford University at 1 site in United States.
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 5 inclusion and 7 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: withdrawn, as of the sponsor's last update on 27 Apr 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2026.