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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Oregon Health and Science University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00972296
First received: September 3, 2009
Last updated: June 28, 2011
Last verified: September 2009
  Purpose

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 Intervention
Arthropathy Due to Bleeding From Hemophilia
Device: Carbon fiber ankle foot orthosis versus cast boot

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Pain relief measured by lower pain score with either AFO or cast boot [ Time Frame: Outcome to be assessed at the time of trial ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement of gait parameters [ Time Frame: To be assessed at time of trial ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: September 2009
Estimated Study Completion Date: June 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients followed at the Oregon Hemophilia Treatment Center

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00972296

Locations
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
  More Information

No publications provided

Responsible Party: David Oleson, PI, Oregon Health & Science University
ClinicalTrials.gov Identifier: NCT00972296     History of Changes
Other Study ID Numbers: DOleson
Study First Received: September 3, 2009
Last Updated: June 28, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hemophilia A
Hemorrhage
Joint Diseases
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Pathologic Processes
Musculoskeletal Diseases
Carbon fiber
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014