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

University Hospital, Angers

Status and phase: Completed; Phase 4

Conditions: Lower Limb Amputation at Ankle (Injury)

Treatments: Device: propriofoot prosthesis

Study type: Interventional

Funder types: Other

Identifiers

NCT02501408

2014-A00374-43

Details and patient eligibility

About

Evaluate a new porosthetic device in lower limb amputees.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Bilateral amputation
• Cancer
• Absence of consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Propriofoot prosthesis

Experimental group

Description:

New propriofoot prosthesis is worn instead of usual prosthesis foer 1 month

Treatment:

Device: propriofoot prosthesis

Control

No Intervention group

Description:

Usual prosthesis is worn for 1 month