Effects of Virtual Reality-Enhanced Rehabilitation on Upper Limb Recovery in Acute Post-Stroke Patients: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Grip strength
研究概览
简要总结
Post-stroke rehabilitation is essential for maximising motor recovery. Virtual reality (VR) is emerging as a promising adjunct to conventional therapy (CRT), potentially enhancing upper limb motor outcomes. The goals of the study are:
- To evaluate the efficiency of VR in addition to CRT on upper limb function in the acute phase of post-stroke rehabilitation, which is underrepresented in the literature.
- To explore the relationship between cognitive impairment and upper limb motor recovery using VR.
The investigators hypothesise that combining VR and CRT improves upper limb functional outcomes in acute stroke beyond the effects of CRT.
详细描述
The investigators will conduct a prospective randomised single- blind pilot controlled trial to evaluate the efficacy of VR-based rehabilitation with the Bimeo PRO system in improving upper limb function in acute post-stroke patients. Participants will be randomly assigned to a two-week program of VR training combined with conventional therapy (experimental group) or conventional therapy alone (control group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Therapists who will evaluate participants with scales will be blinded to group allocation.
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.
- •First-ever acute stroke, occurring <7 days before therapy start.
- •Upper-limb activity limitation with some preserved function (e.g., ability to grasp).
- •Able to understand instructions and provide informed consent.
排除标准
- •Severe cognitive impairment that precludes following instructions.
- •Aphasia or severe visual/hearing impairment that prevents meaningful participation.
- •End-stage/terminal illness.
结局指标
主要结局
Grip strength
时间窗: Change from baseline to 2 weeks (end of intervention)
Grip strength. Will be measured in kilograms using a calibrated hand dynamometer. Participants will perform three maximal efforts with the affected hand while seated (elbow 90°, forearm neutral); the best of three will be recorded for analysis.
The Fugl-Meyer Upper Extremity Assessment (FMA-UE)
时间窗: Change from baseline to 2 weeks (end of intervention)
Fugl-Meyer Upper Extremity Assessment (FMA-UE). Will evaluate post-stroke body functions-motor function, sensation, passive joint motion, and joint pain. Scoring will sum all item scores to a total of 0-126, with higher scores indicating better function.
The Wolf Motor Function Test (WMFT)
时间窗: Change from baseline to 2 weeks (end of intervention)
Wolf Motor Function Test (WMFT). Will assess upper-limb performance with 17 items (2 strength items and 15 timed tasks) that progress from proximal to distal/whole-limb movements. Outcomes will include task times and the Functional Ability Scale (FAS); the mean FAS will be computed as total FAS/15 (range 0-5).
次要结局
- The National Institutes of Health Stroke Scale (NIHSS)(Change from baseline to 2 weeks (end of intervention))
- The Modified Rankin Scale (mRS)(Change from baseline to 2 weeks (end of intervention))
- The Montreal Cognitive Assessment (MoCA)(Change from baseline to 2 weeks (end of intervention))
研究者
Tadeja Hernja Rumpf
Principal Investigator
University Medical Centre Maribor