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

NCT07456306 | Not Yet Recruiting DMC

• 1 other identifier: 24263
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Stroke; Rehabilitation

Keywords

stroke; rehabilitation; virtual-reality; artifficial intelligence

Outcome Measures

Primary Outcomes (1)

• Motor function

  Fugl-Meyer Assessment

  Through study completion, an average of 3 months

Secondary Outcomes (7)

• Neurological sequelae

  Through study completion, an average of 3 months

• Dependence in daily activities

  Through study completion, an average of 3 months

• Spasticity

  Through study completion, an average of 3 months

• Muscle strenght

  Through study completion, an average of 3 months

• Digital biomarkers from VR sessions

  Through study completion, an average of 3 months

Other Outcomes (10)

• Age

  Through study completion, an average of 3 months

• Gender

  Through study completion, an average of 3 months

• Ethiology of the stroke

  Through study completion, an average of 3 months

Study Arms (2)

Receive standard rehabilitation

ACTIVE COMPARATOR

Device: Standard rehabilitation

Receive standard rehabilitation plus AI-driven VR therapy

EXPERIMENTAL

Device: AI-driven VR rehabilitation therapy

Interventions

AI-driven VR rehabilitation therapy DEVICE

AI-drive VR device which improves rehabilitation of upper limb impairment

Receive standard rehabilitation plus AI-driven VR therapy

Standard rehabilitation DEVICE

Standard rehabilitation followed by rehabilitation team and physicians

Receive standard rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Complejo Asistencial Universitario de León Urgencias: lead
• University of Salamanca: collaborator

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Beatriz Villarrubia González Villarrubia, MSc, MD, Dr.

CONTACT

+34 689189775; bvillarrubia@saludcastillayleon.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator. MD. MSc.

Model Details: Experimental group will receive standard rehabilitation plus AI-driven VR therapy during hospitalization. Control group will receive standard rehabilitation alone.

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 6, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03