Randomized Controlled Trial of Artificial Intelligence-Driven Virtual Reality Rehabilitation for Upper Limb Recovery in Acute and Subacute Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Motor function
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Moderate to severe cognitive impairment.
- •Severe global aphasia.
- •Language barrier.
- •Visual impairment.
- •Previous stroke with significant sequelae in upper limb.
- •Contraindication for RHB therapy.
研究组 & 干预措施
Receive standard rehabilitation
干预措施: Standard rehabilitation (Device)
Receive standard rehabilitation plus AI-driven VR therapy
干预措施: AI-driven VR rehabilitation therapy (Device)
结局指标
主要结局
Motor function
时间窗: Through study completion, an average of 3 months
Fugl-Meyer Assessment
次要结局
- Neurological sequelae(Through study completion, an average of 3 months)
- Dependence in daily activities(Through study completion, an average of 3 months)
- Spasticity(Through study completion, an average of 3 months)
- Muscle strenght(Through study completion, an average of 3 months)
- Digital biomarkers from VR sessions(Through study completion, an average of 3 months)
- Patient satisfaction(Through study completion, an average of 3 months)
- Therapy adherence(Through study completion, an average of 3 months)
研究者
Beatriz Villarrubia
Principal investigator. MD. MSc.
Complejo Asistencial Universitario de León Urgencias