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Comparison of Two Types of Ankle Braces in the Management of Ankle Pain in Hemophilia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00972296
Recruitment Status : Completed
First Posted : September 4, 2009
Last Update Posted : April 4, 2017
Information provided by (Responsible Party):
David Oleson, Oregon Health and Science University

Brief Summary:

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

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Study Type : Observational
Actual Enrollment : 27 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Improvement of gait parameters [ Time Frame: To be assessed at time of trial ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients followed at the Oregon Hemophilia Treatment Center

Inclusion Criteria:

  • Hemophilia A or B, with or without inhibitor, with unilateral or bilateral ankle pain

Exclusion Criteria:

  • None

Information from the National Library of Medicine

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 identifier (NCT number): NCT00972296

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United States, Oregon
Child Development and Rehabilitation Center, Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
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Responsible Party: David Oleson, Principal Investigator, Oregon Health and Science University Identifier: NCT00972296    
Other Study ID Numbers: DOleson
First Posted: September 4, 2009    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Joint Diseases
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Musculoskeletal Diseases
Carbon Fiber
Anti-Infective Agents, Local
Anti-Infective Agents