Study of the Effects of a Virtual Reality Balance Training Programme on the Balance and Walking Ability of Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Change in Balance Performance from Baseline to Post-Intervention
研究概览
简要总结
To determine the added value of integrating virtual reality therapy (VRT) based balance training into conventional therapy (CT) for improving balance and gait in subacute stroke patients, and to evaluate the usability and patient satisfaction associated with the VRT based intervention, stroke patients will be recruited in the Neurorehabilitation Department of Erasme University Hospital.
Patients will be randomized to a group performing only CT (CT group) and a group in which 20% of the daily CT was replaced by VRT involving standing balance exercises performed with an immersive headset (VRT group). Functional ambulation classification (FAC), gait speed and step length on 10 meters walking test (10MWT), walking distance on 2 minutes walking test (2MWT) and Berg Balance Scale (BBS) will be assessed at baseline (T0) and post-intervention (T1). Sensory reweighting in the VRT group will also be evaluated through the Sensory Organization Test (SOT) at T0 and T1. Usability of the VR system and patient satisfaction associated with virtual reality will be assessed at T1 in the VRT group through a questionary.
详细描述
Outcomes :
Analyse the effects of a virtual reality balance rehabilitation programme added to conventional therapy on the balance and walking ability of stroke patients.
Analyse feedback from patients who have experienced virtual reality in terms of the usability of the system and patient satisfaction associated with virtual reality.
Participants :
Stroke patients will be recruited in the Neurorehabilitation Department of Erasme University Hospital. Inclusion criteria will be
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
- 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
- •Hemorrhagic or ischemic stroke within the past 6 months,
- •Minimum age of 18 years old,
- •Ability to stand and walk with or without assistance
- •Mini-Mental State Examination score of more than 15/30
- •Ability to understand instructions,
- •No visual deficits hindering VR training and vi) a health status allowing for rehabilitation
排除标准
- •other orthopedic or neurological disease altering the function of the paretic lower limb, balance or gait.
研究组 & 干预措施
Conventional Therapy (CT)
conventional therapy will focus on motor rehabilitation, individualized according to their specific functional needs (exercises for individual deficits and mainly comprised sit-to-stand transfers, balance exercises, walking independence exercises, ergocycle endurance exercises, and dual-task exercises)
干预措施: Standard Conventional Rehabilitation (Other)
Virtual Reality Therapy-Based Rehabilitation (VRT)
This group will benefit from integrating virtual reality therapy (VRT) based balance training into conventional therapy (CT). Conventional therapy will be partially replaced by VRT (20% of the total weekly rehabilitation time over a 2-week period corresponding in five 20-minute segments each week, resulting in a total of 10 VRT sessions) in such a way that the overall daily duration of motor rehabilitation will be equivalent between the VRT and CT groups.
干预措施: Virtual Reality Rehabilitation Program (Other)
结局指标
主要结局
Change in Balance Performance from Baseline to Post-Intervention
时间窗: From enrollment to the end of treatment at 2 weeks
To address this objective, the Berg Balance Scale (0-56 points; higher scores indicate better balance) will be used to assess changes in functional balance performance from baseline to post-intervention.
次要结局
- Change in Sensory Contributions to Postural Control measured by the Sensory Organization Test (SOT).(From enrollment to the end of treatment at 2 weeks)