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

Lower Limb Amputation Clinical Trial

— AMPUTEEFACT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06415955
• Other study ID #: LOCAL/2024/EP-01
• Secondary ID: IRB 24.03.08
• Status: Not yet recruiting
• Start date: June 2024
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Eric PANTERA
• Phone: +(33)4.66.68.25.36
• Email: eric.pantera[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lower Limb Amputation

Intervention

Other:
• None, pure observationnal study
None, pure observationnal study

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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