STRAAL: Walking Strategies in Usual Locomotion of Lower Limb Amputees

Sponsor
FondationbHopale (Other)
Overall Status
Recruiting
CT.gov ID
NCT05420623
Collaborator
Lille Catholic University (Other)
80
1
24
3.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    80 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Determination and Evolution of Usual Locomotion Strategies of Lower Limb Amputees by Gait Analysis
    Actual Study Start Date :
    Dec 15, 2021
    Anticipated Primary Completion Date :
    Dec 15, 2023
    Anticipated Study Completion Date :
    Dec 15, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Amputees patients

    control group: non-amputees

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    3. 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.

    4. 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.

    5. 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.

    6. 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.

    7. 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

    1. The correlations between some data from clinical assessment and gait parameters are analyzed : pain scale (Numerical Rating Scale) [Inclusion]

    2. 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)

    3. 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]

    4. 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]

    5. 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. 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]

    7. 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)

    8. 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]

    9. 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]

    10. 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]

    11. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria (Amputees patients):
    • Major amputation of the lower limb,

    • Unilateral amputation,

    • Aged 18 or over,

    • Mobility level equal to or greater than 2 (according to Medicare Functional Classification Levels),

    • Subject who has given his or her free and informed consent.

    Non-inclusion Criteria (Amputees patients):
    • Definitive apparatus less than one month old,

    • Contraindications for walking,

    • Presence of a major neurocognitive disorder reported in the medical record (as mentioned in the DMS-5): acquired, significant and progressive reduction in abilities in one or more cognitive domains, significant enough to no longer be able to perform activities of daily living alone (loss of autonomy)

    • Cognitive disorders reported in the medical file,

    • Subject under guardianship, curatorship or protective measure,

    • Pregnant or lactating woman.

    Inclusion Criteria (Healthy volunteers):
    • Able to walk 50m alone.
    Non- Inclusion Criteria (Healthy volunteers):
    • Contraindication to effort,

    • Cognitive disorders known by the subject, causing difficulties in performing tasks related to activities of daily living

    • Any history of neurological or orthopedic origin likely to limit the quality of walking,

    • Notion of trauma on the musculoskeletal system less than 3 months (sprain type, muscle injury, etc.),

    • Subject under guardianship, curatorship or protective measure,

    • Pregnant or lactating woman.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fondation HOPALE - Centre de rééducation Jacques CALVE Berck (62600) Hauts De France France 62608

    Sponsors and Collaborators

    • FondationbHopale
    • Lille Catholic University

    Investigators

    • Principal Investigator: Frederic CHARLATE, Fondation Hopale

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    FondationbHopale
    ClinicalTrials.gov Identifier:
    NCT05420623
    Other Study ID Numbers:
    • HOP-RIPH2-21-01
    First Posted:
    Jun 15, 2022
    Last Update Posted:
    Jun 15, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jun 15, 2022