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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00638001
Enrollment
70
Registered
2008-03-18
Start date
2008-03-31
Completion date
2012-03-31
Last updated
2014-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Haemophilia A, Haemophilia B

Keywords

patients with haemophilia A moderate or severe, patients with haemophilia B moderate or severe

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.

Interventions

DEVICEcustom-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

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
13 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Gait analysis, foot pressure measurement, specific joint scoreTo, T1 (3months) and T2 (6months)

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026