## Protocol Section
### Identification Module
**NCT ID:** NCT06415955

**Acronym:** AMPUTEEFACT

**Brief Title:** 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.

#### Organization Study ID Info
**ID:** LOCAL/2024/EP-01
#### Organization
**Class:** OTHER
**Full Name:** Centre Hospitalier Universitaire de Nīmes
#### Secondary ID Infos
**Domain:** IRB CHU de Nîmes
**ID:** IRB 24.03.08
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2024-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Centre Hospitalier Universitaire de Nīmes

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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).

### Conditions Module

**Conditions:**

- Lower Limb Amputation

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 200

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Other: None, pure observationnal study

**Label:** Lower Limb Amputation

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Lower Limb Amputation

**Description:** None, pure observationnal study

**Name:** None, pure observationnal study

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** VO2 consumption as a function of amputation level

**Time Frame:** Before and during performance of a standardised motor task

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

**Measure:** VO2 consumption as a function of gait asymmetry

**Time Frame:** Before and during performance of a standardised motor task

**Description:** 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.

**Measure:** Consumption of VO2 as a function of prosthetic equipment

**Time Frame:** Before and during performance of a standardised motor task

**Description:** 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.

**Measure:** Consumption of VO2 as a function of walking condition.

**Time Frame:** Before and during performance of a standardised motor task

### Eligibility Module

**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.

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** eric.pantera@chu-nimes.fr

**Name:** Eric PANTERA

**Phone:** +(33)4.66.68.25.36

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Centre Hospitalier Universitaire de Nīmes

**Name:** Anissa MEGZARI

**Role:** STUDY_DIRECTOR

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
