Walking Strategies in Usual Locomotion of Lower Limb Amputees (STRAAL)

FondationbHopale

Status: Completed

Conditions: Lower Limb Amputation

Study type: Observational

Funder types: Other

Identifiers

NCT05420623

HOP-RIPH2-21-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

80 participants in 2 patient groups

Amputees patients

control group: non-amputees