Comparison of Two Types of Ankle Braces in the Management of Ankle Pain in Hemophilia
Recruitment status was Active, not recruiting
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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 |
- 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 ]
- 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 |
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
Contacts and Locations
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 May 22, 2013