Skip to main content
OpenTrials
Completed

NCT Number: NCT05420623

Walking Strategies in Usual Locomotion of Lower Limb Amputees

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lower Limb Amputation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondation HOPALE - Centre de rééducation Jacques CALVE

Berck, Hauts-de-France, 62608, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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).

    Time frame: 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 outcomes

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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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).

    Time frame: 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).

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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).

    Time frame: 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.

    Time frame: Inclusion

Sponsors and collaborators

Lead sponsor

FondationbHopale

Other

Collaborators

  • Lille Catholic University

Registry information

Official study title

Determination and Evolution of Usual Locomotion Strategies of Lower Limb Amputees by Gait Analysis

Acronym: STRAAL

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 15, 2022
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.