Rehabilitation, Stroke
Conditions
Keywords
stroke, rehabilitation, virtual-reality, artifficial intelligence
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.
Interventions
DEVICEAI-driven VR rehabilitation therapy
AI-drive VR device which improves rehabilitation of upper limb impairment
DEVICEStandard rehabilitation
Standard rehabilitation followed by rehabilitation team and physicians
Sponsors
Complejo Asistencial Universitario de León Urgencias
University of Salamanca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Experimental group will receive standard rehabilitation plus AI-driven VR therapy during hospitalization. Control group will receive standard rehabilitation alone.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Motor function | Through study completion, an average of 3 months | Fugl-Meyer Assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neurological sequelae | Through study completion, an average of 3 months | NIH Stroke Scale (NIHSS) |
| Dependence in daily activities | Through study completion, an average of 3 months | Modified Rankin Scale (mRS) |
| Spasticity | Through study completion, an average of 3 months | Modified Ashworth Scale (MAS) |
| Muscle strenght | Through study completion, an average of 3 months | Medical Research Council (MRC) scale |
| Digital biomarkers from VR sessions | Through study completion, an average of 3 months | Velocity and accurance of the movements |
| Patient satisfaction | Through study completion, an average of 3 months | Patient self-reporting |
| Therapy adherence | Through study completion, an average of 3 months | Patient self-reporting, |
Contacts
CONTACTBeatriz Villarrubia González Villarrubia, MSc, MD, Dr.
Outcome results
None listed