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Not yet recruiting NCT07456306

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

No phase Interventional Stroke Rehabilitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AI-driven VR rehabilitation therapy, Standard rehabilitation.
Who it may be relevant to
Registry conditions: Stroke, Rehabilitation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Motor function [Time frame: Through study completion, an average of 3 months]
Secondary outcome measures (7)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07456306 · 24263

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗