An interventional study of AI-driven VR rehabilitation therapy and Standard rehabilitation in Stroke and Rehabilitation, sponsored by Complejo Asistencial Universitario de León Urgencias. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-06.
Sponsored by Complejo Asistencial Universitario de León Urgencias · Not applicable, Interventional, and Treatment
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 50 is close to the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Complejo Asistencial Universitario de León Urgencias is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: Standard rehabilitation
Device: AI-driven VR rehabilitation therapy
AI-drive VR device which improves rehabilitation of upper limb impairment
Standard rehabilitation followed by rehabilitation team and physicians
Motor function
Fugl-Meyer Assessment
Time frame: Through study completion, an average of 3 months
Neurological sequelae
NIH Stroke Scale (NIHSS)
Time frame: Through study completion, an average of 3 months
Dependence in daily activities
Modified Rankin Scale (mRS)
Time frame: Through study completion, an average of 3 months
Spasticity
Modified Ashworth Scale (MAS)
Time frame: Through study completion, an average of 3 months
Muscle strenght
Medical Research Council (MRC) scale
Time frame: Through study completion, an average of 3 months
Digital biomarkers from VR sessions
Velocity and accurance of the movements
Time frame: Through study completion, an average of 3 months
Patient satisfaction
Patient self-reporting
Time frame: Through study completion, an average of 3 months
Therapy adherence
Patient self-reporting,
Time frame: Through study completion, an average of 3 months
Age
Years from birth
Time frame: Through study completion, an average of 3 months
Gender
Sex
Time frame: Through study completion, an average of 3 months
Ethiology of the stroke
TOAST clasification
Time frame: Through study completion, an average of 3 months
Dominant-hemisphere
Handedness
Time frame: Through study completion, an average of 3 months
Stroke topography
Clinical exploration
Time frame: Through study completion, an average of 3 months
Aphasia
Clinical Exploration
Time frame: Through study completion, an average of 3 months
Pre-stroke disability
Rankin scale pre-stroke
Time frame: Through study completion, an average of 3 months
Reperfusion treatment
Time frame: Through study completion, an average of 3 months
Time till the start of rehabilitation therapy
Days
Time frame: Through study completion, an average of 3 months
Total of VR-sessions
Number
Time frame: Through study completion, an average of 3 months
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Complejo Asistencial Universitario de León Urgencias