Comparing New Prothesis PROPRIO-FOOT® Versus Usual Prothesis Tasks Tibial Amputees (PROPRIO-FOOT)

October 30, 2017 updated by: University Hospital, Angers

Comparaison du Pied Bionique Proprio-Foot® Versus le Pied Habituel Chez Les amputés Tibiaux

Evaluate a new porosthetic device in lower limb amputees.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Randomisation between usual and new prosthesis Cross over study of walking performance and VO2 on treadmill with the two devices after 1 month adaptation to each system.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49933
        • Centre Hospitalier Universitaire

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:

  • Tibial amputation
  • Ability top walk on treadmill
  • Stable prosthesis for at least 3 months

Exclusion Criteria:

  • Bilateral amputation
  • Cancer
  • Absence of consent

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Propriofoot prosthesis
New propriofoot prosthesis is worn instead of usual prosthesis foer 1 month
Device: propriofoot prosthesis
Adaptation of the device and evaluation after 1 month at home using the studied device
No Intervention: Control
Usual prosthesis is worn for 1 month

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
oxygen consumption
Time Frame: 1 mois after adpatation of the selected device
Measurement on treadmill
1 mois after adpatation of the selected device

Collaborators and Investigators

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

Sponsor

University Hospital, Angers

Investigators

  • Principal Investigator: Pierre Abraham, 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 (Actual)

March 9, 2015

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

April 12, 2017

Study Registration Dates

First Submitted

July 16, 2015

First Submitted That Met QC Criteria

July 16, 2015

First Posted (Estimate)

July 17, 2015

Study Record Updates

Last Update Posted (Actual)

November 1, 2017

Last Update Submitted That Met QC Criteria

October 30, 2017

Last Verified

December 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 2014-A00374-43

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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