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

Lower Limb Amputation at Ankle (Injury) Clinical Trial

— PROPRIO-FOOT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02501408
• Other study ID #: 2014-A00374-43
• Status: Completed
• Phase: Phase 4
• First received: July 16, 2015
• Last updated: October 30, 2017
• Start date: March 9, 2015
• Est. completion date: April 12, 2017

Study information

• Verified date: December 2016
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluate a new porosthetic device in lower limb amputees.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 12, 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Tibial amputation

• Ability top walk on treadmill

• Stable prosthesis for at least 3 months

Exclusion Criteria:

• Bilateral amputation

• Cancer

• Absence of consent

Related Conditions & MeSH terms

• Lower Limb Amputation at Ankle (Injury)

Intervention

Device:
• propriofoot prosthesis
Adaptation of the device and evaluation after 1 month at home using the studied device

Locations

Country	Name	City	State
France	Centre hospitalier universitaire	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oxygen consumption	Measurement on treadmill	1 mois after adpatation of the selected device