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

Phase 4

Completed

• Conditions: Lower Limb Amputation at Ankle (Injury)
• Interventions: Device: propriofoot prosthesis

• Registration Number: NCT02501408
• Lead Sponsor: University Hospital, Angers

Brief Summary

Evaluate a new porosthetic device in lower limb amputees.

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 Timeline

• Study Start: 2015-03-09
• Study First Submitted: 2015-07-16
• Study First Submitted QC: 2015-07-16
• Study First Posted: 2015-07-17
• Status Verified: 2016-12
• Primary Completion: 2017-02
• Study Completion: 2017-04-12
• Last Update Submitted: 2017-10-30
• Last Update Posted: 2017-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Propriofoot prosthesis	propriofoot prosthesis	New propriofoot prosthesis is worn instead of usual prosthesis foer 1 month

Primary Outcome Measures

Name	Time	Method
oxygen consumption	1 mois after adpatation of the selected device	Measurement on treadmill

Trial Locations

Locations (1)

Centre hospitalier universitaire; 🇫🇷 Angers, France