Viewing Study NCT06415955



Ignite Creation Date: 2024-05-19 @ 5:34 PM
Last Modification Date: 2024-10-26 @ 3:29 PM
Study NCT ID: NCT06415955
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-05-16
First Post: 2024-05-13

Brief Title: Identification of Limiting Factors in the Locomotor Activity of Individuals With Lower Limb Amputation
Sponsor: Centre Hospitalier Universitaire de Nīmes
Organization: Centre Hospitalier Universitaire de Nīmes

Study Overview

Official Title: Identification of Limiting Factors in the Locomotor Activity of Individuals With Lower Limb Amputation Biomechanical Physiological Psychological
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: AMPUTEEFACT
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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
IRB 240308 OTHER IRB CHU de Nîmes None