This trial is active, not recruiting.

Condition arthropathy due to bleeding from hemophilia
Treatment carbon fiber ankle foot orthosis versus cast boot
Sponsor Oregon Health and Science University
Start date September 2009
End date June 2011
Trial size 27 participants
Trial identifier NCT00972296, DOleson


This project proposes to examine the difference in effectiveness of fracture boots and carbon fiber braces in the management of gait abnormalities and pain relief due to ankle pain from arthritis due to ankle bleeds. Fracture boots are "walking casts" that you can put on and take off. They prevent the ankle from moving and have a curved sole to mimic normal walking. They can help relieve pain of ankle arthritis from ankle bleeds by stopping ankle motion and absorbing some of the body's own weight while walking. Carbon fiber braces use newer technology resulting in lighter and smaller braces. They are designed to assist with helping clear the toe and straighten the knee while walking.

Gait analysis wearing both the fracture boot and carbon fiber brace will be performed by walking on a mat equipped with pressure sensors and will examine the effect of the fracture boot and the carbon fiber brace on how you walk. These tests will be compared to walking on the mat without either brace. The sensors on the mat will measure different aspects of gait such as step length and foot position. You will be asked questions about how much ankle pain you have using no brace compared to each brace.

People with hemophilia A or B and ankle pain from bleeds will be asked to participate. They will be approached during routine clinic visits and will also be contacted by telephone.

Levels of pain will be measured before, during and after each trial using standardized visual analog and ordinal pain scales. Measurements from the gait mat and levels of pain relief will be used to determine effectiveness of each type of support.

Statisticians will be used to analyze results of the gait mat and pain scale measurements.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective cross-sectional
carbon fiber ankle foot orthosis versus cast boot
Relief of ankle pain and normalizing of gait using either device.

Primary Outcomes

Pain relief measured by lower pain score with either AFO or cast boot
time frame: Outcome to be assessed at the time of trial

Secondary Outcomes

Improvement of gait parameters
time frame: To be assessed at time of trial

Eligibility Criteria

Male or female participants at least 5 years old.

Inclusion Criteria: - Hemophilia A or B, with or without inhibitor, with unilateral or bilateral ankle pain Exclusion Criteria: - None

Additional Information

Official title Comparison of Two Types of Ankle Braces in the Management of Ankle Pain in Hemophilia
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by Oregon Health and Science University.