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

NCT ID: NCT02501408

Last Updated: 2017-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-09

Study Completion Date

2017-04-12

Brief Summary

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Evaluate a new porosthetic device in lower limb amputees.

Detailed Description

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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.

Conditions

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Lower Limb Amputation at Ankle (Injury)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Propriofoot prosthesis

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

Group Type EXPERIMENTAL

propriofoot prosthesis

Intervention Type DEVICE

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

Control

Usual prosthesis is worn for 1 month

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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propriofoot prosthesis

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Bilateral amputation
* Cancer
* Absence of consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre Abraham

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Angers

Locations

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Centre hospitalier universitaire

Angers, , France

Site Status

Countries

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France

Other Identifiers

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2014-A00374-43

Identifier Type: -

Identifier Source: org_study_id