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NCT Number: NCT06415955

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

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).

Recruiting

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Key information

Conditions

Lower Limb Amputation

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nîmes

Nîmes, Gard, 30029, France

Location status: Recruiting

Location contact

Anissa MEGZARI

CONTACT

[email protected]

+ 33 4.66.68.30.09

Eric PANTERA, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

None, pure observationnal study

Other

None, pure observationnal study

Primary outcomes

  1. VO2 consumption as a function of amputation level

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

    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.

  2. VO2 consumption as a function of gait asymmetry

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

    Quantify the cost (Vo2 consumption in mL/kg/min) of a task as a function of gait asymmetry compared with VO2 consumption at rest.

  3. Consumption of VO2 as a function of prosthetic equipment

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

    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.

  4. Consumption of VO2 as a function of walking condition.

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Eric PANTERA

CONTACT

[email protected]

+(33)4.66.68.25.36

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: AMPUTEEFACT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 16, 2024
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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