Impact of Conservative Treatment by Custom-made Orthoses in Patients With Haemophilic Ankle Arthropathy

NCT ID: NCT00638001

Last Updated: 2014-07-11

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

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2012-03-31

Brief Summary

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The purpose of this study intend to evaluate the effectiveness of functional orthoses (including custom-made insoles and shoes) for preventing and controlling repetitive haemarthrosis in patients suffering of haemophilic ankle arthropathy, as well as the orthoses' impact on foot health-related quality of life.

Detailed Description

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Conditions

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Haemophilia A Haemophilia B

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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custom-molded insoles and custom-molded shoes

* custom-made insoles in "PELITE" foam (hypoallergenic prosthesis grade foam) or leather top cover cork insoles for patients suffering of mild to moderate ankle arthropathy
* custom-molded shoes in leather for patients suffering of end-stage ankle arthropathy

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* haemophilia A or B, aged more than 13 years

Exclusion Criteria

* impossibility to walk on a treadmill
* recent joint haemarthrosis or muscle haematoma
Minimum Eligible Age

13 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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cliniques Universitaires Saint Luc

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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READ-LOBET-01

Identifier Type: -

Identifier Source: org_study_id

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