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

NCT03260530 | Completed

• 1 other identifier: CASILLAS PROTEOR 2016
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Lower Limb Amputation

Outcome Measures

Primary Outcomes (1)

• Evolution of self-selected gait speed test, before and after the change or modification of the prosthesis

  12 months

Interventions

Locomotor evaluation OTHER

collection of parameters associated with walking and balance in patients with their usual prosthesis and then equipped with the new prosthesis

Questionnaires OTHER

Houghton's scale, PPA-LCI, ABC, QEP, SF-12, SAT-PRO, ESAT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients attending routine consultations for a prosthesis

You may qualify if:

• Patients able to understand simple instructions, the fitting instructions and to provide informed consent
• Man or woman aged \> 18 years)
• Lower-limb amputee, transtibial or transfemoral amputation

You may not qualify if:

• Adult under guardianship
• Subject without national insurance cover
• Pregnant or breast-feeding women
• Patients with hip desarticulation
• Subjects presenting severe associated diseases affecting gait

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourgogne

Dijon, 21000, France

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2017
• First Posted: August 24, 2017
• Study Start: May 5, 2017
• Primary Completion: September 7, 2023
• Study Completion: September 7, 2023
• Last Updated: June 18, 2024

Record last verified: 2024-06

Locations

FR (1)