Overall Functional Evaluation After Amputation of the Lower Limb;

Status Recruiting

Clinical Trial Summary

It appears necessary to confront the reality of the contribution of technological progress in the creation of prostheses with the specific features of lower limb amputees. These contributions must be clearly identified in their different functional dimensions. This justifies a quantitative approach to the locomotor abilities of these patients, with regard to bioenergy parameters (consumption of oxygen while walking) and motor biomechanical parameters (quantified analysis of movement), so as to measure the real impact of the proposed prosthesis technology, as a complement to classical qualitative approaches. In this context, Dijon CHU, thanks to its Technological Investigation Platform (PIT, CIC 1432), and the company PROTEOR established a research partnership aiming to: - Refine the indications for the prescription of new products, by ensuring that they correspond to the profiles of the patients concerned and their true needs, - Study the underlying adaptive mechanisms, and establish new recommendations for their use, depending on the profiles of the users, - And ultimately, better evaluate, in a more rigorous and systematic manner, the prostheses available on the market. The research protocol presented in this document aims to provide a framework for part of the explorations that will be conducted in the context of this partnership. Lower-limb amputees who will be evaluated in this research will wear these prostheses (foot and/or knee prostheses), which bear the CE logo, and thus present all of the safety and performance conditions required for their use by these patients (prostheses destined for usual prescriptions), the objective of the study was not to evaluate the prostheses as such, but to explore and quantify the impact of these prostheses and their eventual modifications on the locomotor abilities of the patients concerned. The investigations will be conducted using non-invasive evaluation tools available on the PIT platform, with no modification in the usual management of these voluntary patients.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Lower Limb Amputation

Clinical Trial Details

NCT number	NCT03260530
Study type	Observational
Source	Centre Hospitalier Universitaire Dijon
Contact
Status	Recruiting
Phase
Start date	May 5, 2017
Completion date	December 2025

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Overall Functional Evaluation After Amputation of the Lower Limb; Locomotion, Energy Efficiency and Strategies to Adapt to the Prosthesis — PROTEOR

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms