Walking Strategies in Usual Locomotion of Lower Limb Amputees

Lower Limb Amputation Clinical Trial

— STRAAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05420623
• Other study ID #: HOP-RIPH2-21-01
• Status: Recruiting
• Start date: December 15, 2021
• Est. completion date: December 15, 2023

Study information

• Verified date: August 2023
• Source: FondationbHopale
• Contact: Marine Deseur
• Phone: +33362882780
• Email: marine.deseur[@]fondation-hopale.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 15, 2023
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lower Limb Amputation

Locations

Country	Name	City	State
France	Fondation HOPALE - Centre de rééducation Jacques CALVE	Berck (62600)	Hauts De France

Sponsors (2)

Lead Sponsor	Collaborator
FondationbHopale	Lille Catholic University

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	The correlations between some data from clinical assessment and gait parameters are analyzed : pain scale (Numerical Rating Scale)		Inclusion
Secondary	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)	This measurement will be collected with handheld dynamometer (Newton)	Inclusion
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)	This measurement will be collected with handheld dynamometer (Newton)	Inclusion, 6 months, 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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