- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00888498
Ankle Manual Therapy for Ankle Sprains (AMT)
July 1, 2015 updated by: University of the Pacific
Ankle Manual Therapy for Individuals With Post-Acute Ankle Sprains: A Randomized, Placebo-Controlled Trial
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 Overview
Status
Suspended
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Anticipated)
189
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Stockton, California, United States, 95219
- University of the Pacific
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 60 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Hands-On Control
With the subject in a seated position on a treatment table and the lower extremity of interest stabilized to the table with a belt, a single standardized treating investigator will grasp the foot of interested with the thenar eminences on the foot's plantar surface, which is similar to the positioning used for the experimental groups.
The treating investigator will maintain passive positioning of the ankle for the duration of 1 deep inhalation and exhalation by the subject rather than induce an iatrogenic force.
|
With the subject in a seated position on a treatment table and the lower extremity of interest stabilized to the table with a belt, a single standardized treating investigator will grasp the foot of interested with the thenar eminences on the foot's plantar surface, which is similar to the positioning used for the active comparator groups.
The treating investigator will maintain passive positioning of the ankle for the duration of 1 deep inhalation and exhalation by the subject rather than induce an iatrogenic force.
Other Names:
|
EXPERIMENTAL: Fast Stretching
With the subject in a seated position on a treatment table and the lower extremity of interest stabilized to the table with a belt, a single standardized treating investigator will grasp the foot of interested with the thenar eminences on the foot's plantar surface.
A thrust will be delivered parallel to the long axis of the subject's lower leg after the treating therapist induces passive ankle dorsiflexion to end range.
|
With the subject in a seated position on a treatment table and the lower extremity of interest stabilized to the table with a belt, a single standardized treating investigator will grasp the foot of interested with the thenar eminences on the foot's plantar surface.
A thrust will be delivered parallel to the long axis of the subject's lower leg after the treating therapist induces passive ankle dorsiflexion to end range.
Other Names:
|
EXPERIMENTAL: Slow Stretching
With the subject in a seated position on a treatment table and the lower extremity of interest stabilized to the table with a belt, a single standardized treating investigator will grasp the foot of interested with the thenar eminences on the foot's plantar surface.
Traction will be delivered to the talocrural joint at the treating therapist's second perception of tissue resistance in 3 bouts of 30-second holds, separated by 10 seconds of rest.
|
With the subject in a seated position on a treatment table and the lower extremity of interest stabilized to the table with a belt, a single standardized treating investigator will grasp the foot of interested with the thenar eminences on the foot's plantar surface.
Traction will be delivered to the talocrural joint at the treating therapist's second perception of tissue resistance in 3 bouts of 30-second holds, separated by 10 seconds of rest.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Foot and Ankle Ability Measure
Time Frame: Intake, 1 week, 4 weeks, 6 months, 1 year, 2 years
|
Intake, 1 week, 4 weeks, 6 months, 1 year, 2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patient Global Rating of Improvement
Time Frame: Intake, 1 week, 4 weeks, 6 months, 1 year, 2 years
|
Intake, 1 week, 4 weeks, 6 months, 1 year, 2 years
|
Modified Fear Avoidance Beliefs Questionnaire
Time Frame: Intake, 1 week, 4 weeks, 6 months, 1 year, 2 years
|
Intake, 1 week, 4 weeks, 6 months, 1 year, 2 years
|
Lower Extremity Self Efficacy Scale
Time Frame: Intake, 1 week, 4 weeks, 6 months, 1 year, 2 years
|
Intake, 1 week, 4 weeks, 6 months, 1 year, 2 years
|
Positive and Negative Affect Scale
Time Frame: Intake, 1 week, 4 weeks, 6 months, 1 year, 2 years
|
Intake, 1 week, 4 weeks, 6 months, 1 year, 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Beth Fisher, PhD, PT, University of Southern California
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (ANTICIPATED)
December 1, 2015
Study Completion (ANTICIPATED)
December 1, 2015
Study Registration Dates
First Submitted
April 24, 2009
First Submitted That Met QC Criteria
April 24, 2009
First Posted (ESTIMATE)
April 27, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
July 2, 2015
Last Update Submitted That Met QC Criteria
July 1, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UPacific
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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