Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Salamanca | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Receive standard rehabilitation | Active Comparator |
| |
| Receive standard rehabilitation plus AI-driven VR therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI-driven VR rehabilitation therapy | Device | AI-drive VR device which improves rehabilitation of upper limb impairment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Motor function | Fugl-Meyer Assessment | Through study completion, an average of 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Neurological sequelae | NIH Stroke Scale (NIHSS) | Through study completion, an average of 3 months |
| Dependence in daily activities | Modified Rankin Scale (mRS) |
| Measure | Description | Time Frame |
|---|---|---|
| Age | Years from birth | Through study completion, an average of 3 months |
| Gender | Sex | Through study completion, an average of 3 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Beatriz Villarrubia González Villarrubia, MSc, MD, Dr. | Contact | +34 689189775 | bvillarrubia@saludcastillayleon.es |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Experimental group will receive standard rehabilitation plus AI-driven VR therapy during hospitalization. Control group will receive standard rehabilitation alone.
Not provided
Not provided
Not provided
| Standard rehabilitation | Device | Standard rehabilitation followed by rehabilitation team and physicians |
|
| Through study completion, an average of 3 months |
| Spasticity | Modified Ashworth Scale (MAS) | Through study completion, an average of 3 months |
| Muscle strenght | Medical Research Council (MRC) scale | Through study completion, an average of 3 months |
| Digital biomarkers from VR sessions | Velocity and accurance of the movements | Through study completion, an average of 3 months |
| Patient satisfaction | Patient self-reporting | Through study completion, an average of 3 months |
| Therapy adherence | Patient self-reporting, | Through study completion, an average of 3 months |
| Ethiology of the stroke | TOAST clasification | Through study completion, an average of 3 months |
| Dominant-hemisphere | Handedness | Through study completion, an average of 3 months |
| Stroke topography | Clinical exploration | Through study completion, an average of 3 months |
| Aphasia | Clinical Exploration | Through study completion, an average of 3 months |
| Pre-stroke disability | Rankin scale pre-stroke | Through study completion, an average of 3 months |
| Reperfusion treatment | Through study completion, an average of 3 months |
| Time till the start of rehabilitation therapy | Days | Through study completion, an average of 3 months |
| Total of VR-sessions | Number | Through study completion, an average of 3 months |
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided