Ignite Creation Date:
2024-05-06 @ 10:27 AM
Last Modification Date:
2024-10-26 @ 12:30 PM
Study NCT ID:
NCT03260530
Status:
COMPLETED
Last Update Posted:
2024-06-18
First Post:
2017-08-22
Brief Title:
Overall Functional Evaluation After Amputation of the Lower Limb Locomotion Energy Efficiency and Strategies to Adapt to the Prosthesis
Sponsor:
Centre Hospitalier Universitaire Dijon
Organization:
Centre Hospitalier Universitaire Dijon
Study Overview
Official Title:
Overall Functional Evaluation After Amputation of the Lower Limb Locomotion Energy Efficiency and Strategies to Adapt to the Prosthesis
Status:
COMPLETED
Status Verified Date:
2024-06
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:
PROTEOR
Brief 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 andor 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
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 andor 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
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