Peut-on améliorer la Marche de l'amputé fémoral en Guidant la Correction prothétique Par l'Analyse Des Pressions Dans l'emboîture ?
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Two minute Walking Test
研究概览
简要总结
This study aims at evaluating the relation between quality of the interface between the stump and the prosthesis, and the quality of gait in above-knee amputees.
The hypothesis is that an adapted prosthesis allowing an efficient gait in above-knee amputees corresponds to an homogeneous pressure distribution pattern onto the stump.
详细描述
Forty amputee patients will be evaluated for satisfaction with the prosthesis, pressure repartition pattern and functional capabilities.
Pressure at the stump-socket interface will be recorded using a set of 14 single cells sensors placed in predefined positions onto the stump. Pattern of pressure will be measured in four tasks: sitting posture, standing posture, gait initiation, and gait at preferred velocity.
Reproducibility of the pressure repartition pattern will be analyzed by repeating gait and standing posture task in the first 15 patients included.
In patients whom prosthesis has been modified on the basis on the first pressure measurement (pressure peak and bad functional capacities), a new pressure measurement will be repeated 2-8 weeks apart.
Postural and gait abilities will be also assessed in 40 age/gender matched non-amputated subjects to serve as control data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 是
入选标准
- •Amputee patients:
- •Inclusion Criteria:
- •unilateral transfemoral amputation
- •use of a prosthesis with a "contact" socket
排除标准
- •neurological or muscular disorder likely to impair walking capabilities
- •Mini Mental State Examination below 24/30
- •Healthy subjects :
- •Exclusion Criteria:
- •neurological or muscular disorder likely to impair walking capabilities
- •Mini Mental State Examination below 24/30
研究组 & 干预措施
Evaluation
First, the assessment will be performed to evaluate the relationship between pressure repartition pattern, clinical evaluation and motor capabilities. All the patients and volunteers will be concerned by this first part.
A second part will be conducted in 15 amputees within the 40 patients. Assessments of pressure pattern during gait and standing will be repeated two times: by the same investigator and by a different investigator, in order to test intra- and inter-evaluator reproducibility.
After the first assessment, the prosthesis may be modified in order to solve clinical problems. In that case, a new assessment will be proposed 2 to 8 weeks after in order to test the effect of the prosthesis modification on pressure pattern, gait, posture and clinical parameters.
干预措施: Clinical and instrumented measurements (Device)
结局指标
主要结局
Two minute Walking Test
时间窗: At inclusion (baseline) for all patients
Maximal distance(m)walked during 2 minutes (one trial)
次要结局
- Variation coefficient of maximal pressure during standing posture(At inclusion for all patients)
- Reproducibility of the Variation Coefficients of maximal pressures(At baseline)
- Variation coefficient of maximal pressures during gait(At inclusion (Baseline) for all patients)
- Gait spatial and temporal parameters(At inclusion for all patients)
- Change in two minutes walk tests between Baseline and 5 Weeks(Five weeks (W5) in average after inclusion in patients in whom the prosthesis will be modified)
- Change in the variation coefficients of maximal pressures between Baseline and 5 Weeks(5 Weeks in average (2 and 8 weeks) after the inclusion in patients in whom the prosthesis will be modified)