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临床试验/NCT05420623
NCT05420623已完成不适用

Determination and Evolution of Usual Locomotion Strategies of Lower Limb Amputees by Gait Analysis

FondationbHopale1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年12月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Data from the quantified gait assessment: walking speed (m/s)

研究概览

简要总结

Amputation is a life-altering event with an immediate and obvious effect on daily life activities and quality of life. Asymmetrical movements of the lower limbs and compensatory strategies during walking are associated with an elevated risk for developing deleterious secondary health conditions. It is well established that therapeutic gait training methods are effective in reducing spatiotemporal gait deviations and improving functional mobility. However, the littérature does not clearly indicate the best time to perform a gait training or which gait parameters predict it.

The main aim of this study is to determinate the walking strategies of lower limb amputees in several locomotion tasks on daily life. Then, the investigators study the evolution of these walking strategies after a gait training and over time.

详细描述

Quantified gait analyses are included in the practice for consultations to monitor orthopaedic devices, and are specific to the study for the rehabilitation stay (V2 and V3).

The subjects in the control group will be recruited from among the carers of patients undergoing rehabilitation and from among volunteers recruited by means of posters in the establishments of the HOPALE Foundation in Berck.

Once the eligibility criteria have been checked, a quantified gait analysis and functional tests will be carried out: the 6-minute walk test (T6M) and the Time Up and Go test (TUG). They will complete a single visit lasting approximately 1 hour and 30 minutes.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Data from the quantified gait assessment: walking speed (m/s)

时间窗: Inclusion

Full body motion capture was systematically analyzed for different walking conditions * normal and fast walking on self selected walking speed, walking on cross-slope, go up and down a step, and turn.

Data from the quantified gait assessment: step time (s)

时间窗: Inclusion

Full body motion capture was systematically analyzed for different walking conditions * normal and fast walking on self selected walking speed, walking on cross-slope, go up and down a step, and turn.

Data from the quantified gait assessment: step length (m)

时间窗: Inclusion

Full body motion capture was systematically analyzed for different walking conditions * normal and fast walking on self selected walking speed, walking on cross-slope, go up and down a step, and turn.

Data from the quantified gait assessment: lower limbs joint angles (degrees)

时间窗: Inclusion

Full body motion capture was systematically analyzed for different walking conditions * normal and fast walking on self selected walking speed, walking on cross-slope, go up and down a step, and turn.

Data from the quantified gait assessment: joint moments (N.m/kg)

时间窗: Inclusion

Full body motion capture was systematically analyzed for different walking conditions * normal and fast walking on self selected walking speed, walking on cross-slope, go up and down a step, and turn.

Data from the quantified gait assessment: trunk and pelvis position (degrees)

时间窗: Inclusion

Full body motion capture was systematically analyzed for different walking conditions * normal and fast walking on self selected walking speed, walking on cross-slope, go up and down a step, and turn.

Data from the quantified gait assessment: ground reaction forces (N).

时间窗: Inclusion

Full body motion capture was systematically analyzed for different walking conditions * normal and fast walking on self selected walking speed, walking on cross-slope, go up and down a step, and turn.

次要结局

  • The correlations between some data from clinical assessment and gait parameters are analyzed : strenght testing of hip abductor/extensor/flexor and knee extensor/flexor (if applicable)(Inclusion)
  • The correlations between some data from clinical assessment and gait parameters are analyzed : amputation level and etiology, prosthesis characteristics, functional walking tests (timed up and go test - in seconds).(Inclusion)
  • The correlations between some data from clinical assessment and gait parameters are analyzed : amputation level and etiology, prosthesis characteristics, functional walking tests (six minute walk test - in meters).(Inclusion)
  • These clinical assessment and these gait parameters on the conditions mentioned are analyzed before and after rehabilitation during consultations, and then at 6 months and at 12 months : pain scale (Numerical Rating Scale)(Inclusion, 6 months, 12 months)
  • If you need a walking aid, the investigators compares the force applied to the walking aid, using a force sensor (Newton), with biomechanical compensations.(Inclusion)
  • These clinical assessment and these gait parameters on the conditions mentioned are analyzed before and after rehabilitation, and at 6 and 12 months: strenght testing of hip abductor/extensor/flexor and knee extensor/flexor (if applicable)(Inclusion, 6 months, 12 months)
  • The correlations between some data from clinical assessment and gait parameters are analyzed : pain scale (Numerical Rating Scale)(Inclusion)
  • The correlations between some data from clinical assessment and gait parameters are analyzed : amputation level and etiology, prosthesis characteristics, lower limbs range of motion with manual goniometer (degrees)(Inclusion)
  • These clinical assessment and these gait parameters on the conditions mentioned are analyzed before and after rehabilitation during consultations, and then at 6 months and at 12 months : lower limbs range of motion with manual goniometer (degrees)(Inclusion, 6 months, 12 months)
  • These clinical assessment and these gait parameters on the conditions mentioned are analyzed before and after rehabilitation during consultations, and then at 6 months and at 12 months : functional walking tests (timed up and go test, in seconds)(Inclusion, 6 months, 12 months)
  • The correlations between some data from clinical assessment and gait parameters are analyzed : amputation level and etiology, prosthesis characteristics, functional walking tests (six-minute walk test, in meters).(Inclusion, 6 months, 12 months)

研究者

发起方
FondationbHopale
申办方类型
Other
责任方
Sponsor

研究点 (1)

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