Evaluation of a Geriatric Foot- 1M10 ADJUST Versus the Solid Ankle Cushioned Heel Foot for Low Activity Amputees
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 14
- 主要终点
- 10 meter walk test
研究概览
简要总结
The purpose of this study is to determine whether the geriatric prosthetic foot 1M10 is superior to the classical SACH (Solid Ankle Cushion Heel) foot, when used by indoor ambulators with a transtibial amputation.
详细描述
Fourteen limited ambulators , unilateral trans tibial amputees, will be recruited in the orthopedic rehabilitation department in our institute. Participants will be assigned randomly to be fitted with a SACH or a 1M10 Otto Bock foot in their prosthesis.
Both types of feet will be "dressed" to look similarly. All participants will receive the same rehabilitation protocol. After three weeks all participants will be tested functionally in the "10 meter walk test" , and a "Get up and go test". The participants will answer a satisfaction questionnaire that is based on the "Prosthesis Evaluation Questionnaire" and modified according to the aims of this trial.
Pressure patterns and gait parameters will be recorded using a pressure mat. At this time the foot will be switched to the other study prosthetic foot, and the rehabilitation will commence.
At the end of three weeks wearing the new foot the same set of tests will be run again.
The investigators aim to present the difference in satisfaction and in the functional performance of the same participant wearing the two feet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •unilateral transtibial amputees
- •limited ambulators
排除标准
- •do not speak Hebrew
- •are not cognitively intact
研究组 & 干预措施
SACH first
Will use a SACH foot for the first three weeks of prosthetic gait training , and a 1M10 foot for the second three weeks of prosthetic gait training
干预措施: SACH prosthetic foot, 1M10 prosthetic foot (Device)
1M10 first
Will use a 1M10 foot for the first three weeks of prosthetic gait training , and a SACH foot for the second three weeks of prosthetic gait training
干预措施: SACH prosthetic foot, 1M10 prosthetic foot (Device)
结局指标
主要结局
10 meter walk test
时间窗: Measured after 6 weeks
The participants will be asked to walk at their comfort pace 10 meters. The time of completing the task will be recorded
Prosthetic satisfaction Questionnaire
时间窗: Measured after 3 weeks
Hebrew satisfaction questionnaire
Get up and go test
时间窗: Measured after 6 weeks
The participants will be asked to get up from a chair walk 3 meters turn around walk back to the chair and sit down. The time of completing the task will be recorded
Prosthetic Satisfaction Questionnaire
时间窗: Measured after 6 weeks
Hebrew satisfaction questionnaire
10 meter walk test
时间窗: Measured after 3 weeks
The participants will be asked to walk at their comfort pace 10 meters. The time of completing the task will be recorded
Get up and go test
时间窗: Measured after 3 weeks
The participants will be asked to get up from a chair walk 3 meters turn around walk back to the chair and sit down. The time of completing the task will be recorded.
次要结局
- Gait patterns(Measured after 6 weeks)
- Gait patterns(Measured after 3 weeks and)