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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorCentre Hospitalier Universitaire de Nīmes

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients with uncorrected or untreated visual disorders.

Patients with major cognitive impairment (MOCA>23).

Patients with vestibular disorders.

Patient with uncontrolled epilepsy.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • None, pure observationnal study

    Other intervention

    None, pure observationnal study

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Lower Limb Amputation1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Before and during performance of a standardised motor task
2

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.

Time frame
Before and during performance of a standardised motor task
3

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.

Time frame
Before and during performance of a standardised motor task
4

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.

Time frame
Before and during performance of a standardised motor task

Secondary outcomes

Other outcomes

Sponsors and contacts

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