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

Evaluate a new porosthetic device in lower limb amputees.

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Key information

Conditions

Lower Limb Amputation at Ankle (Injury) Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre hospitalier universitaire

Angers, 49933, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Bilateral amputation
Cancer
Absence of consent

Treatment and study plan

propriofoot prosthesis

Device

Adaptation of the device and evaluation after 1 month at home using the studied device

Primary outcomes

oxygen consumption

Time frame: 1 mois after adpatation of the selected device

Measurement on treadmill

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study title

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

Acronym: PROPRIO-FOOT

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: Jul 17, 2015
Registry last updated: Nov 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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