Early Postoperative Fitting of the Air- Limb Prosthesis for Transtibial Amputees
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- The duration of rehabilitation of transtibial amputees, from amputation until the fitting of the permanent prosthesis.
研究概览
简要总结
The aim of the study is to check whether an early adjustment of the Air-Limb prosthesis to Transtibial amputees due to vascular diseases, will shorten the healing time of the stump and the process of rehabilitation.
详细描述
The method of immediate adjustment of a temporary Prosthesis has been developed in the past, aiming to reduce the healing time of the stump and the process of rehabilitation. According to this method, a temporary Prosthesis is being adjusted immediately after amputation, or during the first week after it. Rehabilitation starts with the patient's standing while partial weight bearing on the Prosthesis.
In spite of many experiments and trials to adopt this process of rehabilitation, it is not universally adopted, because of the bad adjustment and damages to the stump caused by the Plaster of Paris. At present, with the improvement of materials and research experiments are being renewed, to check the efficiency of the process, using the Air- Limb a temporary Prosthesis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Transtibial amputees due to vascular diseases.
排除标准
- •Bilateral amputation.
- •Upper extremity can't bear weight.
- •The sound leg can't bear weight.
- •Amputee that needs Dialysis treatment.
- •Cognitive impairment.
结局指标
主要结局
The duration of rehabilitation of transtibial amputees, from amputation until the fitting of the permanent prosthesis.
时间窗: 1-4 month
The total duration of the rehabilitation process,from amputation until the end of the hospitalization, with the permanent prosthesis.
时间窗: 2-6 month
次要结局
- The duration of stump healing and functional status of transtibial amputees.(1-6 month)