NCT07456306

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Complejo Asistencial Universitario de León Urgencias · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	AI-driven VR rehabilitation therapy	AI-drive VR device which improves rehabilitation of upper limb impairment
DEVICE	Standard rehabilitation	Standard rehabilitation followed by rehabilitation team and physicians

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-06-01
• Completion: 2026-08-01
• First posted: 2026-03-06
• Last updated: 2026-03-06