Validating the Efficacy of Activities of Daily Living (ADL)-Focused Virtual Reality (VR) in Upper-Limb Rehabilitation for Acquired Brain Injury (ABI) Individuals: A Pilot Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Assessment for Upper Extremity
研究概览
简要总结
Acquired brain injury (ABI) individuals have shown greater engagement and functional recovery when trained in virtual reality (VR)-assisted rehabilitation therapies.
After developing an activities of daily living (ADL)-focused VR system in a prior study, this related follow-up study aims to test the efficacy and impact of this VR system on upper-limb rehabilitation outcomes of ABI individuals when routinely integrated into treatment plans.
详细描述
After completion of informed consent, patients will undergo screening assessments to determine eligibility for study participation.
All eligible participants integrate VR into rehabilitation treatment plans twice per week for 12 weeks. Graphical complexity increases progressively throughout the study: "Simple" in Weeks 1-4, "Standard" in Weeks 5-8, and "Complex" in Weeks 9-12. Assessments are conducted at pre-intervention and post-intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •acquired brain injury with upper extremity impairment
- •Fugl-Meyer Assessment of Upper Extremity (FMA-UE) score of 20 points or more
- •able to follow commands and instructions
- •least 2 months post-stroke, in the subacute or chronic recovery phase
排除标准
- •- contraindications that increase susceptibility to VR-related adverse events and/or prevent completion of training tasks, such as seizures, epilepsy, visual acuity deficits (besides glasses), vertigo, nystagmus, motion sensitivity, or other non-ABI conditions that impede upper limb movement
研究组 & 干预措施
ADL-Focused Virtual Reality
Participants will receive 24 one-hour rehabilitation sessions with a licensed occupational therapist trained in stroke recovery and with the VR system. Each therapy session will include range of motion and general strengthening activities as well as 20-30 minutes of the intervention (ADL-focused upper-limb virtual reality training). The goal is to complete rehabilitative training in 12 weeks, with each participant training two times per week.
干预措施: Cooking In the Kitchen (Device)
结局指标
主要结局
Fugl-Meyer Assessment for Upper Extremity
时间窗: Baseline (pre-intervention), Week 6, and End-of-Study (post-intervention, Week 13)
The Fugl-Meyer Assessment (FMA) is a physical performance impairment index that evaluates motor recovery. Domains of motor function, sensation, balance, range of motion, and pain are measured on a 3-point ordinal scale. The upper extremity (UE) section score ranges from 0 to 66, with higher scores indicating less impairment.
次要结局
- Stroke Impact Scale(Baseline (pre-intervention) and End-of-Study (post-intervention, Week 13))
- Lawton Instrumental Activities of Daily Living(Baseline (pre-intervention) and End-of-Study (post-intervention, Week 13))
研究者
Hee-Tae Jung
Assistant Professor, Health Informatics
Indiana University