StrokeNCT07456306
Artificial Intelligence-Driven Virtual Reality Rehabilitation for Upper Limb Recovery in Acute and Subacute Stroke Patients
A study testing AI-driven VR rehabilitation therapy and Standard rehabilitation in people with Stroke and Rehabilitation, run by Complejo Asistencial Universitario de León Urgencias.
Trial summary
Background: Upper limb motor deficits are common after stroke, and early rehabilitation is crucial for functional recovery. Virtual reality (VR) combined with artificial intelligence (AI) has shown potential to enhance motor learning, but evidence from randomized controlled trials in acute and subacute hospitalized… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Rehabilitation
- What is being tested?
- AI-driven VR rehabilitation therapy and Standard rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 1 Aug 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥18 years
- Confirmed acute or subacute stroke (ischemic or hemorrhagic)
- Upper limb motor deficits
- Admitted to hospital
- Favourable assessment by the rehabilitation service to begin treatment
- Signing of informes consent
Who cannot join
- Moderate to severe cognitive impairment.
- Severe global aphasia.
- Language barrier.
- Visual impairment.
- Previous stroke with significant sequelae in upper limb.
- Contraindication for RHB therapy.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Beatriz Villarrubia González Villarrubia, MSc, MD, Dr. contact
About this study
Official title: Randomized Controlled Trial of Artificial Intelligence-Driven Virtual Reality Rehabilitation for Upper Limb Recovery in Acute and Subacute Stroke Patients
Background: Upper limb motor deficits are common after stroke, and early rehabilitation is crucial for functional recovery. Virtual reality (VR) combined with artificial intelligence (AI) has shown potential to enhance motor learning, but evidence from randomized controlled trials in acute and subacute hospitalized patients is limited.
Objective: To evaluate whether AI-driven VR rehabilitation in addition to standard care improves upper limb motor recovery compared with standard rehabilitation alone in acute and subacute stroke patients.
Read more
Design: Prospective, assessor-blinded, randomized controlled trial with stratified 1:1 allocation by baseline Fulg Meyer Assessment Score.S Participants: Adults (≥18 years) with confirmed acute or subacute stroke, admitted to the hospital, with upper limb motor déficits.
Intervention: Experimental group will receive standard rehabilitation plus AI-driven VR therapy during hospitalization. Control group will receive standard rehabilitation alone.
Primary Outcome: Change in FM-UE score from baseline to hospital discharge. Secondary Outcomes: VR-derived digital biomarkers, therapy adherence, NIHSS, FM-UE, and Modified Ashworth Scale at each session, and the following baseline and treatment variables: etiology, Modified Rankin Scale (mRS), handedness, stroke lateralization, aphasia, acute reperfusion, reperfusion treatment, days from stroke to start of rehabilitation, adverse events, patient satisfaction, and date of discharge. FM-UE at 1 month post-intervention.
Randomization and Blinding: Patients will be randomized in a 1:1 ratio to either group, stratified by baseline FM-UE (≤30 vs >30) to ensure balance between groups for stroke severity. Within each stratum, block randomization will be used. Outcome assessors will be blinded.
Sample Size: 50 patients (25 per group).
Ethics and Registration: Approved by hospital ethics committee. Significance: This trial will provide evidence on the effectiveness of AI-driven VR therapy for early upper limb rehabilitation in hospitalized stroke patients.
- Conditions
- Stroke, Rehabilitation
- Being tested
- AI-driven VR rehabilitation therapy, Standard rehabilitation
- Keywords
- stroke, rehabilitation, virtual-reality, artifficial intelligence
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-driven VR rehabilitation therapyDevice
AI-drive VR device which improves rehabilitation of upper limb impairment
Standard rehabilitationDevice
Standard rehabilitation followed by rehabilitation team and physicians
| Study group | Role | What they receive |
|---|---|---|
| Receive standard rehabilitation | Active comparator | Not described Receives: Device: Standard rehabilitation |
| Receive standard rehabilitation plus AI-driven VR therapy | Experimental | Not described Receives: Device: AI-driven VR rehabilitation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor function
Fugl-Meyer Assessment
Measured: Through study completion, an average of 3 months
Secondary outcomes (7)
Neurological sequelae
NIH Stroke Scale (NIHSS)
Measured: Through study completion, an average of 3 months
Dependence in daily activities
Modified Rankin Scale (mRS)
Measured: Through study completion, an average of 3 months
Spasticity
Modified Ashworth Scale (MAS)
Measured: Through study completion, an average of 3 months
Muscle strenght
Medical Research Council (MRC) scale
Measured: Through study completion, an average of 3 months
Digital biomarkers from VR sessions
Velocity and accurance of the movements
Measured: Through study completion, an average of 3 months
Patient satisfaction
Patient self-reporting
Measured: Through study completion, an average of 3 months
Therapy adherence
Patient self-reporting,
Measured: Through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
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.
- 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
- Model description
- Experimental group will receive standard rehabilitation plus AI-driven VR therapy during hospitalization. Control group will receive standard rehabilitation alone.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Complejo Asistencial Universitario de León Urgencias
- Sponsor type
- University, hospital or other
- Collaborators
- University of Salamanca
- Responsible party
- Principal investigator, Beatriz Villarrubia, Complejo Asistencial Universitario de León Urgencias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07456306
- Sponsor's protocol ID
- 24263
- Status last verified
- Mar 2026
- First submitted
- 24 Feb 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Artificial Intelligence-Driven Virtual Reality Rehabilitation for Upper Limb Recovery in Acute and Subacute Stroke Patients
- ClinicalTrials.gov ID
- NCT07456306
- Acronym / sponsor ID
- 24263
- Conditions
- Stroke, Rehabilitation
- Keywords
- stroke, rehabilitation, virtual-reality, artifficial intelligence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Complejo Asistencial Universitario de León UrgenciasUniversity, hospital or other
- Collaborators
- University of Salamanca
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 6 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.
Background: Upper limb motor deficits are common after stroke, and early rehabilitation is crucial for functional recovery. Virtual reality (VR) combined with artificial intelligence (AI) has shown potential to enhance motor learning, but evidence from randomized controlled trials in acute and subacute hospitalized patients is limited.
Objective: To evaluate whether AI-driven VR rehabilitation in addition to standard care improves upper limb motor recovery compared with standard rehabilitation alone in acute and subacute stroke patients.
Design: Prospective, assessor-blinded, randomized controlled trial with stratified 1:1 allocation by baseline Fulg Meyer Assessment Score.S Participants: Adults (≥18 years) with confirmed acute or subacute stroke, admitted to the hospital, with upper limb motor déficits.
Intervention: Experimental group will receive standard rehabilitation plus AI-driven VR therapy during hospitalization. Control group will receive standard rehabilitation alone.
Primary Outcome: Change in FM-UE score from baseline to hospital discharge. Secondary Outcomes: VR-derived digital biomarkers, therapy adherence, NIHSS, FM-UE, and Modified Ashworth Scale at each session, and the following baseline and treatment variables: etiology, Modified Rankin Scale (mRS), handedness, stroke lateralization, aphasia, acute reperfusion, reperfusion treatment, days from stroke to start of rehabilitation, adverse events, patient satisfaction, and date of discharge. FM-UE at 1 month post-intervention.
Randomization and Blinding: Patients will be randomized in a 1:1 ratio to either group, stratified by baseline FM-UE (≤30 vs >30) to ensure balance between groups for stroke severity. Within each stratum, block randomization will be used. Outcome assessors will be blinded.
Sample Size: 50 patients (25 per group).
Ethics and Registration: Approved by hospital ethics committee. Significance: This trial will provide evidence on the effectiveness of AI-driven VR therapy for early upper limb rehabilitation in hospitalized stroke patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Experimental group will receive standard rehabilitation plus AI-driven VR therapy during hospitalization. Control group will receive standard rehabilitation alone.
| Arm | Type | Receives |
|---|---|---|
| Receive standard rehabilitation | Active comparator | Device: Standard rehabilitation |
| Receive standard rehabilitation plus AI-driven VR therapy | Experimental | Device: AI-driven VR rehabilitation therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults ≥18 years
- Confirmed acute or subacute stroke (ischemic or hemorrhagic)
- Upper limb motor deficits
- Admitted to hospital
- Favourable assessment by the rehabilitation service to begin treatment
Key exclusion criteria (6 listed)
- Moderate to severe cognitive impairment.
- Severe global aphasia.
- Language barrier.
- Visual impairment.
- Previous stroke with significant sequelae in upper limb.
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 |
|---|---|---|
| AI-driven VR rehabilitation therapyAI-drive VR device which improves rehabilitation of upper limb impairment | Device | Receive standard rehabilitation plus AI-driven VR therapy |
| Standard rehabilitationStandard rehabilitation followed by rehabilitation team and physicians | Device | Receive standard rehabilitation |
Primary outcome
Motor function
Time frame: Through study completion, an average of 3 months
Fugl-Meyer Assessment
7 secondary outcomes
Neurological sequelae
Time frame: Through study completion, an average of 3 months
Dependence in daily activities
Time frame: Through study completion, an average of 3 months
Spasticity
Time frame: Through study completion, an average of 3 months
Muscle strenght
Time frame: Through study completion, an average of 3 months
Digital biomarkers from VR sessions
Time frame: Through study completion, an average of 3 months
Patient satisfaction
Time frame: Through study completion, an average of 3 months
Therapy adherence
Time frame: Through study completion, an average of 3 months
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 6 Mar 2026.
- 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.
Beatriz Villarrubia González Villarrubia, MSc, MD, Dr. contact
Questions about this trial
What is this clinical trial studying?
A study testing AI-driven VR rehabilitation therapy and Standard rehabilitation in people with Stroke and Rehabilitation, run by Complejo Asistencial Universitario de León Urgencias.
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 6 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 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Beatriz Villarrubia González Villarrubia, MSc, MD, Dr. (+34 689189775, bvillarrubia@saludcastillayleon.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor function (time frame: Through study completion, an average of 3 months). 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 6 Mar 2026.