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

NCT ID: NCT00972296

Last Updated: 2017-04-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 27 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2017-04-30

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.

Conditions

Arthropathy Due to Bleeding From Hemophilia

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Persons with hemophilia with ankle pain

Carbon fiber ankle foot orthosis versus cast boot

Intervention Type: DEVICE

Relief of ankle pain and normalizing of gait using either device.

Interventions

Carbon fiber ankle foot orthosis versus cast boot

Relief of ankle pain and normalizing of gait using either device.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None

• Minimum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

David Oleson

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Child Development and Rehabilitation Center, Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

References

1. Bladen M, Alderson L, Khair K, Liesner R, Green J, Main E. Can early subclinical gait changes in children with haemophilia be identified using the GAITRite® walkway, Haemophilia; Sep2007, Vol. 13 Issue 5, p542-547 2. Wall J, Bruni B, Chapter 17, Clinical Gait Analysis: Temporal and Distance Parameters, Assessment in Occupational Therapy and Physical Therapy, edited by J.V. Van Deusen, 1996

Reference Type: BACKGROUND

Other Identifiers

DOleson

Identifier Type: -

Identifier Source: org_study_id