Clinical trial NCT06415955: Identification of Limiting Factors in the Locomotor Activity of Individuals With Lower Limb Amputation:
Official title: Identification of Limiting Factors in the Locomotor Activity of Individuals With Lower Limb Amputation: Biomechanical, Physiological, Psychological.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Lower Limb Amputation
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief summary: 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: 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.

Primary outcomes:
measure: VO2 consumption as a function of amputation level
timeFrame: Before and during performance of a standardised motor task
measure: VO2 consumption as a function of gait asymmetry
timeFrame: Before and during performance of a standardised motor task
measure: Consumption of VO2 as a function of prosthetic equipment
timeFrame: Before and during performance of a standardised motor task
measure: Consumption of VO2 as a function of walking condition.
timeFrame: Before and during performance of a standardised motor task
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Centre Hospitalier Universitaire de Nīmes
name: Anissa MEGZARI
role: STUDY_DIRECTOR
References: