Investigation of the Effect of Virtual Reality-Mediated Rehabilitation on Upper Extremity Functions in Ischemic Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Fugl-Meyer upper extremity scale
研究概览
简要总结
The aim of the study was to investigate the effectiveness of virtual reality-mediated upper extremity rehabilitation added to the conventional rehabilitation program on upper extremity, quality of life, range of motion and spasticity in patients with stroke.
详细描述
This prospective, randomized and controlled study will be conducted with patients diagnosed with stroke. Among the patients who are admitted to outpatient or inpatient rehabilitation program in SBU Kanuni Sultan Süleyman PMR clinic, 30 patients diagnosed with stroke who meet the inclusion criteria will be included in the study. Patients diagnosed with stroke will be randomized into two groups using a computer program (Virtual reality group, control group). Participants in both groups will receive a conventional rehabilitation program. Participants in the virtual reality group will receive virtual reality-mediated upper extremity rehabilitation for 3 weeks, 5 sessions per week, each session lasting 30 minutes (total 450 minutes). In the virtual reality intervention, participants will be asked to control the games with hand, wrist and forearm movements in front of a computer screen in front of the SensoRehab® sensor that can detect hand movements through gloves. 3 different games will be intervened for 10 minutes each, totaling 30 minutes per day.
Participants in the control group will be instructed in hand, finger, wrist and forearm therapeutic exercises by a physiotherapist.
After the intervention, patients will be evaluated in terms of upper extremity functions, quality of life, range of motion and spasticity.
All evaluations will be repeated before, after and 3 months after the intervention. Routine 3-month PMR outpatient clinic control is recommended for patients with stroke. Therefore, no additional hospital visit is requested from the patients due to the study.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 65 years of age,
- •History of Ischemic Stroke
- •Accept to participate in the study,
排除标准
- •Presence of known central nervous system or peripheral nervous system disease other than stroke, presence of progressive neurologic deficit,
- •Uncontrolled hypertension, diabetes, cardiovascular disease etc.
- •Cognitive impairment causing difficulty in executing simple commands
- •Botulinum toxin application to the upper extremity in the last 6 months
- •Change in the medical treatment used for spasticity in the last 6 months
- •Pregnancy.
研究组 & 干预措施
Control Group
Participants in the control group will be instructed in hand, finger, wrist and forearm therapeutic exercises by a physiotherapist. Participants in both groups will receive a conventional rehabilitation program.
干预措施: conventional rehabilitation program (Other)
Virtual Reality Group
Participants in both groups will receive a conventional rehabilitation program. Participants in the virtual reality group will receive virtual reality-mediated upper extremity rehabilitation for 3 weeks, 5 sessions per week, each session lasting 30 minutes (450 minutes in total). In the virtual reality intervention, participants will be asked to control the games with hand, wrist and forearm movements in front of a computer screen in front of the SensoRehab® sensor that can detect hand movements through gloves. 3 different games will be intervened for 10 minutes each, totaling 30 minutes per day.
干预措施: Virtual Reality Mediated Upper Extremity Rehabilitation (SensoRehab®) (Device)
Virtual Reality Group
Participants in both groups will receive a conventional rehabilitation program. Participants in the virtual reality group will receive virtual reality-mediated upper extremity rehabilitation for 3 weeks, 5 sessions per week, each session lasting 30 minutes (450 minutes in total). In the virtual reality intervention, participants will be asked to control the games with hand, wrist and forearm movements in front of a computer screen in front of the SensoRehab® sensor that can detect hand movements through gloves. 3 different games will be intervened for 10 minutes each, totaling 30 minutes per day.
干预措施: conventional rehabilitation program (Other)
Control Group
Participants in the control group will be instructed in hand, finger, wrist and forearm therapeutic exercises by a physiotherapist. Participants in both groups will receive a conventional rehabilitation program.
干预措施: Exercise (Behavioral)
结局指标
主要结局
Fugl-Meyer upper extremity scale
时间窗: Change from Baseline Fugl-Meyer upper extremity scale at 3rd Month After Intervention
This scale is a stroke-specific, performance-based scale and each parameter is scored as 0; unsuccessful, 1; partially successful and 2; completely successful performance. This scale consists of five sections: motor function, balance, sensation, range of motion and pain. The motor function assessment section is scored as 100 points (66 upper extremities and 34 lower extremities), sensation (light touch and position sense) 24 points, balance (6 sitting and 8 standing) 14 points, range of motion 44 points and joint pain 44 points.
次要结局
- Modified Ashworth Scale(Change from Baseline Modified Ashworth Scale at 3rd Month After Intervention)
- Functional Independence Measure(Change from Baseline Functional Independence Measure at 3rd Month After Intervention)
- Handgrip Strength(Change from Baseline Handgrip Strength at 3rd Month After Intervention)
- Stroke Impact Scale(Change from Baseline Stroke Impact Scale. at 3rd Month After Intervention)
研究者
Ahmet Kivanc Menekseoglu
Principal Investigator
Istanbul University