NCT07456306

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

Not yet recruiting NA Last updated 6 March 2026

What this trial tests

NA trial testing AI-driven VR rehabilitation therapy in Stroke in 50 participants. Not yet recruiting.

Timeline

1 March 2026

Primary endpoint
1 June 2026

1 August 2026

Quick facts

Lead sponsor	Complejo Asistencial Universitario de León Urgencias
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	50
Start date	1 March 2026
Primary completion	1 June 2026
Estimated completion	1 August 2026

Drugs / interventions tested

• AI-driven VR rehabilitation therapy
• Standard rehabilitation

Conditions studied

• Stroke — all drugs for Stroke →
• Rehabilitation — all drugs for Rehabilitation →

Sponsor

Complejo Asistencial Universitario de León Urgencias — full company profile →

Who can join

18 and older, any sex, with Stroke or Rehabilitation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.