Back to resultsImpact of Conservative Treatment by Custom-made Orthoses in Patients With Haemophilic Ankle Arthropathy
Primary Purpose
Haemophilia A, Haemophilia B
Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
custom-molded insoles and custom-molded shoes
Sponsored by
About this trial
This is an interventional treatment trial for Haemophilia A focused on measuring patients with haemophilia A moderate or severe, patients with haemophilia B moderate or severe
Eligibility Criteria
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
Sites / Locations
- cliniques Universitaires Saint Luc
Outcomes
Primary Outcome Measures
Gait analysis, foot pressure measurement, specific joint score
Secondary Outcome Measures
Full Information
NCT ID
NCT00638001
First Posted
February 26, 2008
Last Updated
July 10, 2014
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1. Study Identification
Unique Protocol Identification Number
NCT00638001
Brief Title
Impact of Conservative Treatment by Custom-made Orthoses in Patients With Haemophilic Ankle Arthropathy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Haemophilia A, Haemophilia B
Keywords
patients with haemophilia A moderate or severe, patients with haemophilia B moderate or severe
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
custom-molded insoles and custom-molded shoes
Intervention Description
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
Primary Outcome Measure Information:
Title
Gait analysis, foot pressure measurement, specific joint score
Time Frame
To, T1 (3months) and T2 (6months)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
cliniques Universitaires Saint Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Impact of Conservative Treatment by Custom-made Orthoses in Patients With Haemophilic Ankle Arthropathy
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