Evaluation of Correlations Between Different Walk Tests in Patients With Transfemoral Amputees

May 6, 2016 updated by: University Hospital, Angers

Evaluation of Correlations Between the 2 Minutes, 6 Minutes and 2 Kilometers Walk Tests in Patients With Transfemoral Amputees With a Microprocessor-controlled Prosthetic Knees

Lower limb amputation (LLA) is a major public health problem, with significant human and financial impact. Epidemiological data remain scarce in the literature. The primary objective of the equipment of lower limb amputees is to give a walking ability and autonomy that are closest to the previous state before the amputation. About microprocessor-controlled prosthetic knees (MPKs), there are currently three in France who benefit from support by health insurance : 3C100 knee C-leg (Otto Bock HealthCare, Duderstadt, Germany), the Rheo Knee (Ossur, Reykjavik, Iceland) and knee HYBRID 1P360 (Proteor, Saint Apollinaire, France). These prostheses have the common feature of being equipped with a single-axis prosthetic knee, controlled by a microprocessor, wich allows to adapt instantly to the user's walking speed changes. They are indicated in the proximal amputations of the lower limbs from knee disarticulation included. Their prescription can only be made by a doctor of Physical Medicine and Rehabilitation. These prostheses are subject to four criteria attribution and reimbursement by the List of Products and Services Refundable (LPPR = Liste des Produits et Prestations Remboursables). This criteria are the ability to: have a walking speed greater than or equal to 4 km/h, walk 2km continuous, descend an inclined slop of 15% and to walk down the stairs step by step. These criteria must be validated after a minimum trial period of 15 days.

These attribution criteria raise the question today of how they are measured, no recommendation defining this procedure. While many standardized assessment tests of different gait parameters are available and used in clinical research, the attribution criteria are not being built in reference to these tests.

The overall objective of the study is to evaluate the diagnostic value of two simple clinical tests, the 2 and 6 minutes walk tests, to assess functional performance in patients with transfemoral amputees with a microprocessor-controlled Prosthetic Knees (MPKs).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • >18 years
  • to be major, with a proximal lower extremity amputation (from knee disarticulation included until hemipelvectomy)
  • to have a microprocessor controlled prosthetic knee among the 3C100C-leg, the RHEO Knee or HYBRID 1P360 for over a month

Exclusion Criteria:

  • unstable angina or myocardial infarction dated less than one month,
  • pregnancy or breastfeeding
  • acute event responsible for a restriction in walking
  • refusal to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2 minutes walk test
fast walk test during 2 minutes in first and the 10 meters walk test, the 6 minutes walk test and the 2 kilometers walk test
Other: Evaluation of the correlation between walking speed in the 6MWT and in 2MWT, and the walking speed observed in the continuous 2km walk test and in the 10 meters walk test.
Experimental: 6 minutes walk test
comfortable walk test during 6 minutes in first and the 10 meters walk test, the 2 minutes walk test and the 2 kilometers walk test
Other: Evaluation of the correlation between walking speed in the 6MWT and in 2MWT, and the walking speed observed in the continuous 2km walk test and in the 10 meters walk test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
- The percentage of variance of the speed of the continuous 2km walk test and 10 meters walk test explained by the velocity estimated respectively by the 2MWT and the 6 MWT
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

July 1, 2016

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

May 4, 2016

First Submitted That Met QC Criteria

May 6, 2016

First Posted (Estimate)

May 9, 2016

Study Record Updates

Last Update Posted (Estimate)

May 9, 2016

Last Update Submitted That Met QC Criteria

May 6, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 2016-A00054-47

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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