Identification of Limiting Factors in the Locomotor Activity of Individuals With Lower Limb Amputation: (AMPUTEEFACT)

Identification of Limiting Factors in the Locomotor Activity of Individuals With Lower Limb Amputation: Biomechanical, Physiological, Psychological.

The experience of amputation leads to a deterioration in quality of life, with undeniable somatic and functional repercussions. The result is a reduction in general mobility, increased metabolic energy requirements and a feeling of discomfort and pain. The rehabilitation objectives focus on improving, or at least maintaining, the range of movement of the lower limbs, strengthening the overall muscles, ensuring that the equipment is correctly adapted, re-training for physical exertion and working on balance and walking. The rehabilitation objectives focus on social inclusion with the equipment, to optimise the return home and promote social and professional reintegration, and therapeutic education. Factors influencing the postoperative resumption of walking in amputees have been identified as key elements in the success of rehabilitation management. These include maintaining joint range of motion before fitting any equipment, combating postoperative loss of muscle mass, managing cardiorespiratory deconditioning and, finally, resuming walking with the aid of equipment, taking account of fluctuating balance.

The literature shows that a change in the centre of gravity and postural instability, particularly when changing stance, are responsible for a greater risk of falls in lower-limb amputees. This asymmetry of gait, which is the cause of a greater risk of secondary joint degeneration, is found in both transtibial and transfemoral amputees. This alteration in balance has a direct influence on walking ability, and therefore calls for significant proprioceptive management in the rehabilitation programme. Gait analysis in lower-limb amputees therefore seems essential, both for the purposes of evaluating and monitoring rehabilitation treatment, and for prosthetic selection and adjustment. Three-dimensional assessment of walking in amputees, coupled with force platforms, is the test of choice for providing kinematic, kinetic and spatiotemporal data (motion capture).

Study Overview

• Status: Not yet recruiting
• Conditions: Lower Limb Amputation
• Intervention / Treatment: Other: None, pure observationnal study

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Eric PANTERA; Phone Number: +(33)4.66.68.25.36; Email: eric.pantera@chu-nimes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with lower limb amputations, unilateral or bilateral, walking with or without technical aids, whatever the level (trans-femoral or trans-tibial) and hospitalised in the locomotor rehabilitation department. Patients who were not autonomous enough to walk and required a third person (human aid) were not included.

Description

Inclusion Criteria:

• Amputees in PRM hospitalisation at the CHU Nîmes RRL service University Rehabilitation Hospital in Le Grau du Roi.
• All aetiologies: vascular, traumatic and septic.
• Appropriate vascular equipment validated by PRM doctor.
• Able to walk for 5 minutes on a treadmill.
• Patient affiliated to or benefiting from a health insurance scheme.
• Adult patient (>18 years) and under 80 years of age.

Exclusion Criteria:

• Patients with uncorrected or untreated visual disorders.
• Patients with major cognitive impairment (MOCA>23).
• Patients with vestibular disorders.
• Patient with uncontrolled epilepsy.
• Patient with an unhealed amputation stump.
• Weight > 135kg or < 20kg
• Patients with a FAC of 1 (i.e. patients requiring the firm and continuous assistance of another person to carry their weight and maintain their balance) or less.
• Inability to properly adjust the sling to the corresponding body part due to:
• Body shape
• Colostomy bags
• Skin lesions that cannot be adequately protected.
• Any other reason that prevents the harness from being adjusted correctly and painlessly.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lower Limb Amputation; Patients with lower limb amputations, unilateral or bilateral, walking with or without technical aids, at any level (trans-femoral or trans-tibial) and hospitalised in the locomotor rehabilitation department of the Nîmes University Hospital.	Other: None, pure observationnal study; None, pure observationnal study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VO2 consumption as a function of amputation level	To quantify the cost (consumption of Vo2 in mL/kg/min) of a task as a function of the level of amputation. VO2 consumption is measured using a VO2 master calorimetric mask, which analyses gas exchange for 3 minutes. To quantify the cost of the task, VO2 consumption over the 3rd minute is used, normalised in relation to VO2 consumption at rest.	Before and during performance of a standardised motor task
VO2 consumption as a function of gait asymmetry	Quantify the cost (Vo2 consumption in mL/kg/min) of a task as a function of gait asymmetry compared with VO2 consumption at rest.	Before and during performance of a standardised motor task
Consumption of VO2 as a function of prosthetic equipment	To quantify the cost (consumption of Vo2 in mL/kg/min) of a task as a function of the prosthetic equipment compared with the consumption of VO2 at rest.	Before and during performance of a standardised motor task
Consumption of VO2 as a function of walking condition.	To quantify the cost (consumption of Vo2 in mL/kg/min) of a task as a function of the walking condition compared with the consumption of VO2 at rest.	Before and during performance of a standardised motor task

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Study Director: Anissa MEGZARI, Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: May 13, 2024
• First Submitted That Met QC Criteria: May 13, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: LOCAL/2024/EP-01; IRB 24.03.08 (Other Identifier: IRB CHU de Nîmes)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No