Comparison of Two Types of Ankle Braces in the Management of Ankle Pain in Hemophilia
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|ClinicalTrials.gov Identifier: NCT00972296|
Recruitment Status : Completed
First Posted : September 4, 2009
Last Update Posted : April 4, 2017
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.
|Condition or disease||Intervention/treatment|
|Arthropathy Due to Bleeding From Hemophilia||Device: Carbon fiber ankle foot orthosis versus cast boot|
|Study Type :||Observational|
|Actual Enrollment :||27 participants|
|Official Title:||Comparison of Two Types of Ankle Braces in the Management of Ankle Pain in Hemophilia|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||April 2017|
|Persons with hemophilia with ankle pain||
Device: Carbon fiber ankle foot orthosis versus cast boot
Relief of ankle pain and normalizing of gait using either device.
- Pain relief measured by lower pain score with either AFO or cast boot [ Time Frame: Outcome to be assessed at the time of trial ]
- Improvement of gait parameters [ Time Frame: To be assessed at time of trial ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00972296
|United States, Oregon|
|Child Development and Rehabilitation Center, Oregon Health & Science University|
|Portland, Oregon, United States, 97239|