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

April 3, 2017 updated by: David Oleson, Oregon Health and Science University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

27

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Child Development and Rehabilitation Center, Oregon Health & Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients followed at the Oregon Hemophilia Treatment Center

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement of gait parameters
Time Frame: To be assessed at time of trial
To be assessed at time of trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

September 3, 2009

First Submitted That Met QC Criteria

September 3, 2009

First Posted (Estimate)

September 4, 2009

Study Record Updates

Last Update Posted (Actual)

April 4, 2017

Last Update Submitted That Met QC Criteria

April 3, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DOleson

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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