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View Clinical Trial (Medical Research Study)

Ankle Manual Therapy for Ankle Sprains - NCT00888498-97477 (Clinical Trial 289042)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy289042.aspx



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City:  Eugene
State:  
OR
Zip Code: 97477
Conditions: Sprains and Strains
Purpose: The purpose of this study is to determine the effect of using ankle manual therapy procedures on clinical outcomes in individuals with post-acute ankle sprains.
Study summary: Ankle sprains can cause ankle joint stiffness. Ankle joint stiffness may be a cause of pain, disability, and repeated sprains. Physical therapists use many ways to treat ankle joints that do not move well. One way takes 1-2 seconds. Another way may take up to 1 minute. Both kinds of stretches seem to improve ankle flexibility. However, we do not know how well they work to improve pain and disability in individuals following ankle sprains. The purpose of this research is to find out which physical therapy treatments work best for people with ankle sprains. To start the study, subjects will be asked to fill out some forms that ask about their ankle problem. Subjects will receive an examination by a physical therapist that includes gentle movements of the feet and legs to test their flexibility, strength, and balance. Subjects will then be assigned to 1 of 3 treatments to be provided by a separate physical therapist. They will not get to choose their group. All 3 groups will receive ankle stretching by the physical therapist. The groups will differ in how much and how fast the stretch will be. The first group will have an ankle stretch that lasts 1-2 seconds. The second group will have a stretch that lasts 1 minute. The third group will have their foot held without any stretching. After stretching, all subjects will receive the same kind of exercise program. Study-related treatment will last 5 sessions over 4 weeks, with 2 sessions for stretching within the 1st week and 1 session per week for the 3 following weeks for the exercise program. After 1 week and 4 weeks, subjects will fill out the same forms as at the initial examination. The treatment part of the study will then be finished. After 6 months, 1 year, and 2 years from enrollment in the study, subjects be asked to fill out many of the same forms that ask about their ankle problem. We think subjects that get a stretch will have a better outcome than subjects that get ankle holding. To test our idea, we will compare how subjects in each group tell us they are doing with their ankle problem on the Foot and Ankle Ability Measure at 1 week, 4 weeks, 6 months, 1 year, and 2 years following entry into the study. Since the way a person thinks and feels about their injury may have something to do with how much they improve during physical therapy, we will also measure these factors to find out if they affect the results of this study.
Criteria: Inclusion Criteria: - Age 16-60 years - Onset of ankle sprain at least 2 weeks prior to enrollment - Foot and Ankle Ability Measure Activity of Daily Living subscale score less than or equal to 80% Exclusion Criteria: - Current status of assisted ambulation (eg, use of cane or crutches) - Inability to bear weight through the affected extremity immediately after injury combined with tenderness to palpation of the medial and lateral malleolar zones, styloid process of the 5th metatarsal, and navicular - Positive anterior drawer or talar tilt dimple test - Volume of the affected limb greater than 10% of the unaffected limb - Previous history of ligament or bony reconstructive surgery to the ankle and foot - Concomitant injury to other lower extremity joints
Study is available at: Therapeutic Associates - Oregon Medical Group
Eugene, OR 97477
United States

Primary Contact:
Ben Bleazard
Phone: 541-242-4870

Secondary Contact:
Todd E Davenport, PT, DPT, OCS
Email: tdavenport@pacific.edu
Phone: (209) 946-3159
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 16, 2010
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Clinical trials are medical research studies designed to test the safety and/or effectiveness of new drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.


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