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Clinical Trials/NCT05420623
NCT05420623
Completed
N/A

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

FondationbHopale1 site in 1 country80 target enrollmentDecember 16, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Lower Limb Amputation
Sponsor
FondationbHopale
Enrollment
80
Locations
1
Primary Endpoint
Data from the quantified gait assessment: walking speed (m/s)
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
December 16, 2021
End Date
December 16, 2023
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
FondationbHopale
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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).

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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