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Walking Strategies in Usual Locomotion of Lower Limb Amputees

Completed
Conditions
Lower Limb Amputation
Registration Number
NCT05420623
Lead Sponsor
FondationbHopale
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
80
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Data from the quantified gait assessment: walking speed (m/s)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)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)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)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)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)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).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 Outcome Measures
NameTimeMethod
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

This measurement will be collected with handheld dynamometer (Newton)

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

This measurement will be collected with handheld dynamometer (Newton)

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

Trial Locations

Locations (1)

Fondation HOPALE - Centre de rééducation Jacques CALVE

🇫🇷

Berck (62600), Hauts de France, France

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