Investigation of the Influence of Virtual Reality on the Postoperative Period After Major Amputation.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Barthel Index
研究概览
简要总结
The goal of this clinical trial is to test the impact of virtual reality on rehabilitation for the patients after a major amputation.
The main questions it aims to answer are:
- Does the virtual-reality-assisted rehabilitation improve the life quality of patients (i.e. lesser pain, better spirit)?
- Does the virtual-reality-assisted rehabilitation improve the daily life function of the patients? Participants will received a virtual-reality-assisted rehabilitation on the second postoperative day for ten days. The rehabilitation would be carried out two times per day and 30 minutes per training.
详细描述
Despite the increasing development of revascularisation techniques, lower limb amputation often represent the last chance of survival for the vasculopathic patient with chronic limb threatening ischemia (CLTI). First goal after lower limb amputation is represented by a rapid prosthesis application. The patient in the immediate post-operative period must undergo intensive rehabilitation and physiotherapy, which involves not only a physical but also a psychological approach.
"Classical" recovery following lower limb amputation includes adequate pain therapy and physiotherapy to regain independence, strength, mobility and finally prothesis application to improve quality of life and restore mobility. The aim of this study is to investigate the effect of adding virtual reality to traditional rehabilitation following a lower limb amputation in patients due to limited circulation, with particularly attention to a possible improvement of psychological state, reduction of post-operative pain and more rapid improvement in regaining functional mobility
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
The researcher analyzing the final outcomes is blinded from the personal information and execution of the rehabilitation of the patients.
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
- •> 18 years
- •critical limb ischemia or acute limb ischemia
- •amputation above/below knee
- •unilateral lower limb amputees
排除标准
- •physical disability (paralysis, plegia)
- •inability to give informed consent
- •neurological or psychiatric problem that reduces compliance
- •loss of planned post-operative assessments
- •traumatic amputation in a patient without circulatory disorders
结局指标
主要结局
Barthel Index
时间窗: single time point (1 day)
The change in activities of daily life among the patients before and after the implementation of the training program.
The Morton Mobility Index (DEMMI)
时间窗: single time point (1 day)
The change in mobility outcomes among the patients before and after the implementation of the training program.
Esslinger Transfer Scale
时间窗: single time point (1 day)
The change in the level of assistance needed for a safe transfer among the patients before and after the implementation of the training program.
次要结局
- SF-12® Health Survey(single time point (1 day))
- 6-point Likert-scale(single time point (1 day))
- Situational Motivational Scale(single time point (1 day))
研究者
Ulrich Rother
PD Dr. med.
University Hospital Erlangen