Artificial Intelligence-Driven Virtual Reality Rehabilitation for Upper Limb Recovery in Acute and Subacute Stroke Patients

March 4, 2026 updated by: Beatriz Villarrubia, Complejo Asistencial Universitario de León Urgencias

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.

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

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

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:

  • 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

Exclusion Criteria:

  • Moderate to severe cognitive impairment.
  • Severe global aphasia.
  • Language barrier.
  • Visual impairment.
  • Previous stroke with significant sequelae in upper limb.
  • Contraindication for RHB therapy.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Receive standard rehabilitation
Device: Standard rehabilitation
Standard rehabilitation followed by rehabilitation team and physicians
Experimental: Receive standard rehabilitation plus AI-driven VR therapy
Device: AI-driven VR rehabilitation therapy
AI-drive VR device which improves rehabilitation of upper limb impairment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor function
Time Frame: Through study completion, an average of 3 months
Fugl-Meyer Assessment
Through study completion, an average of 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurological sequelae
Time Frame: Through study completion, an average of 3 months
NIH Stroke Scale (NIHSS)
Through study completion, an average of 3 months
Dependence in daily activities
Time Frame: Through study completion, an average of 3 months
Modified Rankin Scale (mRS)
Through study completion, an average of 3 months
Spasticity
Time Frame: Through study completion, an average of 3 months
Modified Ashworth Scale (MAS)
Through study completion, an average of 3 months
Muscle strenght
Time Frame: Through study completion, an average of 3 months
Medical Research Council (MRC) scale
Through study completion, an average of 3 months
Digital biomarkers from VR sessions
Time Frame: Through study completion, an average of 3 months
Velocity and accurance of the movements
Through study completion, an average of 3 months
Patient satisfaction
Time Frame: Through study completion, an average of 3 months
Patient self-reporting
Through study completion, an average of 3 months
Therapy adherence
Time Frame: Through study completion, an average of 3 months
Patient self-reporting,
Through study completion, an average of 3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Age
Time Frame: Through study completion, an average of 3 months
Years from birth
Through study completion, an average of 3 months
Gender
Time Frame: Through study completion, an average of 3 months
Sex
Through study completion, an average of 3 months
Ethiology of the stroke
Time Frame: Through study completion, an average of 3 months
TOAST clasification
Through study completion, an average of 3 months
Dominant-hemisphere
Time Frame: Through study completion, an average of 3 months
Handedness
Through study completion, an average of 3 months
Stroke topography
Time Frame: Through study completion, an average of 3 months
Clinical exploration
Through study completion, an average of 3 months
Aphasia
Time Frame: Through study completion, an average of 3 months
Clinical Exploration
Through study completion, an average of 3 months
Pre-stroke disability
Time Frame: Through study completion, an average of 3 months
Rankin scale pre-stroke
Through study completion, an average of 3 months
Reperfusion treatment
Time Frame: Through study completion, an average of 3 months
Through study completion, an average of 3 months
Time till the start of rehabilitation therapy
Time Frame: Through study completion, an average of 3 months
Days
Through study completion, an average of 3 months
Total of VR-sessions
Time Frame: Through study completion, an average of 3 months
Number
Through study completion, an average of 3 months

Collaborators and Investigators

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

Sponsor

Complejo Asistencial Universitario de León Urgencias

Collaborators

University of Salamanca

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 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

February 24, 2026

First Submitted That Met QC Criteria

March 4, 2026

First Posted (Actual)

March 6, 2026

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24263

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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