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OpenTrials
Completed

NCT Number: NCT03260530

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Dijon Bourgogne

Dijon, 21000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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

Primary outcomes

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

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: PROTEOR

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Aug 24, 2017
Registry last updated
Jun 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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