Walking Strategies in Usual Locomotion of Lower Limb Amputees

NCT ID: NCT05420623

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-16
• Study Completion Date: 2023-12-16

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.

Conditions

Lower Limb Amputation

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Amputees patients

No interventions assigned to this group

control group: non-amputees

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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,
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lille Catholic University

OTHER

Sponsor Role: collaborator

FondationbHopale

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frederic CHARLATE

Role: PRINCIPAL_INVESTIGATOR

Fondation Hopale

Locations

Fondation HOPALE - Centre de rééducation Jacques CALVE

Berck, Hauts-de-France, France

Countries

France

Other Identifiers

HOP-RIPH2-21-01

Identifier Type: -

Identifier Source: org_study_id