Arthropathy Due to Bleeding From Hemophilia Clinical Trial
Official title:
Comparison of Two Types of Ankle Braces in the Management of Ankle Pain in Hemophilia
| Verified date | April 2017 |
| Source | Oregon Health and Science University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 27 |
| Est. completion date | April 2017 |
| Est. primary completion date | May 2011 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 5 Years and older |
| Eligibility |
Inclusion Criteria: - Hemophilia A or B, with or without inhibitor, with unilateral or bilateral ankle pain Exclusion Criteria: |
| Country | Name | City | State |
|---|---|---|---|
| United States | Child Development and Rehabilitation Center, Oregon Health & Science University | Portland | Oregon |
| Lead Sponsor | Collaborator |
|---|---|
| Oregon Health and Science University |
United States,
Bladen M, Alderson L, Khair K, Liesner R, Green J, Main E. Can early subclinical gait changes in children with haemophilia be identified using the GAITRite walkway. Haemophilia. 2007 Sep;13(5):542-7. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pain relief measured by lower pain score with either AFO or cast boot | Outcome to be assessed at the time of trial | ||
| Secondary | Improvement of gait parameters | To be assessed at time of trial |