View Clinical Trial (Medical Research Study)
Ankle Manual Therapy for Individuals With Post-Acute Ankle Sprains: A Randomized, Placebo-Controlled Trial
| City: |
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Bend |
| State: |
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Oregon |
| Zip Code: |
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97756 |
| Conditions: |
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Sprains and Strains |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT00888498 |
| Primary Contact: |
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Principal Investigator
Todd E Davenport, PT, DPT, OCS
University of the Pacific
Todd E Davenport, PT, DPT, OCS
Phone: (209) 946-3159
Email: tdavenport@pacific.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Bend, Oregon 97756
United States
Karen Walz
Phone: 541-923-7494
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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