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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02501408
Recruitment Status : Completed
First Posted : July 17, 2015
Last Update Posted : November 1, 2017
Information provided by (Responsible Party):
University Hospital, Angers

Brief Summary:
Evaluate a new porosthetic device in lower limb amputees.

Condition or disease Intervention/treatment Phase
Lower Limb Amputation at Ankle (Injury) Device: propriofoot prosthesis Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparaison du Pied Bionique Proprio-Foot® Versus le Pied Habituel Chez Les amputés Tibiaux
Actual Study Start Date : March 9, 2015
Actual Primary Completion Date : February 2017
Actual Study Completion Date : April 12, 2017

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. oxygen consumption [ Time Frame: 1 mois after adpatation of the selected device ]
    Measurement on treadmill

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Bilateral amputation
  • Cancer
  • Absence of consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02501408

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Centre hospitalier universitaire
Angers, France, 49933
Sponsors and Collaborators
University Hospital, Angers
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Principal Investigator: Pierre Abraham University Hospital, Angers
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Responsible Party: University Hospital, Angers Identifier: NCT02501408    
Other Study ID Numbers: 2014-A00374-43
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: December 2016