Walking Strategies in Usual Locomotion of Lower Limb Amputees

NCT05420623 | Completed

• 1 other identifier: HOP-RIPH2-21-01
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Limb Amputation

Outcome Measures

Primary Outcomes (7)

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

  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.

  Inclusion

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

  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.

  Inclusion

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

  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.

  Inclusion

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

  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.

  Inclusion

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

  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.

  Inclusion

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

  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.

  Inclusion

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

  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.

  Inclusion

Secondary Outcomes (11)

• 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 : 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, lower limbs range of motion with manual goniometer (degrees)

  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

Study Arms (2)

Amputees patients

control group: non-amputees

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Visits are carried out as part of routine care, either in the case of a follow-up consultation, or as part of a scheduled entry into a rehabilitation center. If the patient is included at the entrance of a scheduled rehabilitation stay, the data from his last follow-up consultation will be recovered retrospectively (follow-up AQM + functional tests). Recruitment of healthy volunteers : The study will be offered to the companions of people followed in rehabilitation at the Jacques Calvé center. Posters will be placed at the reception desk of the institution and in the consultation waiting rooms.

You may qualify if:

• 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.
• 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.
• \- Able to walk 50m alone.
• 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,

Sponsors & Collaborators

• FondationbHopale: lead
• Lille Catholic University: collaborator

Study Sites (1)

Fondation HOPALE - Centre de rééducation Jacques CALVE

Berck, Hauts-de-France, 62608, France

Location

Study Officials

• Frederic CHARLATE

  Fondation Hopale

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: June 15, 2022
• Study Start: December 16, 2021
• Primary Completion: December 16, 2023
• Study Completion: December 16, 2023
• Last Updated: January 7, 2025

Record last verified: 2023-08

Locations

FR (1)