Weight-bearing Training Exercise May Improve Loading of Trans-tibial Prosthesis and Functional Gait
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in centre of pressure (COP) from baseline
研究概览
简要总结
A simple weight-bearing exercise has been designed using off-the-shelves devices (Nintendo Wii Balance Board) and centre of pressure (COP) analysis software (Python) for trans-tibial amputees receiving their first prosthesis. A pilot randomised control study will be conducted to check the progress with weight-bearing training using COP-based objective measures. Additionally, gait and functional task performance will be assessed by means of clinical test. Participants will be divided into 2 groups: test group (performing additional weight-bearing exercises) and control group (receiving only conventional training for fitting of initial prosthesis).
详细描述
Each patient meeting the inclusion criteria will be randomised to either the test group or the control group. The patients will perform ten training sessions with the initial prosthesis, each session lasting for about 30 minutes, within the period of two weeks. They will be assessed at baseline and after the training program.
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
- •trans-tibial amputation,
- •fitted with first trans-tibial prosthesis,
- •independent mobility for 50m with or without assistive aid,
- •Functional Independence Measure (FIM) Stairs locomotion scale ≥ 5,
- •ability to follow the instructions, Mini Mental State Examination (MMSE) > 25,
- •no severe visual problems, ble to see computer screen,
- •willing to participate.
排除标准
- •bilateral lower limb amputation or any other level of unilateral lower limb amputation,
- •not candidates for prosthetic fitting.
结局指标
主要结局
Change in centre of pressure (COP) from baseline
时间窗: Assessment at baseline and after two weeks
Calculation of COP (transversal plane, symmetry index, lateral, sagittal directions) from 4 pressure sensors built into the balance board
Change in weight distribution in quiet standing
时间窗: Assessment at baseline and after two weeks
COP assessment for 20s of quiet standing
次要结局
- Change in 10m walk test(Assessment at baseline and after two weeks)
- Change in L-test(Assessment at baseline and after two weeks)