Ankle Manual Therapy for Ankle Sprains (AMT)
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Sprains and Strains |
Other: Passive Positioning Other: High-Velocity, Low-Amplitude Stretch Other: Slow, Mobilization Stretch |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Ankle Manual Therapy for Individuals With Post-Acute Ankle Sprains: A Randomized, Placebo-Controlled Trial |
- Foot and Ankle Ability Measure [ Time Frame: Intake, 1 week, 4 weeks, 6 months, 1 year, 2 years ] [ Designated as safety issue: No ]
- Patient Global Rating of Improvement [ Time Frame: Intake, 1 week, 4 weeks, 6 months, 1 year, 2 years ] [ Designated as safety issue: No ]
- Modified Fear Avoidance Beliefs Questionnaire [ Time Frame: Intake, 1 week, 4 weeks, 6 months, 1 year, 2 years ] [ Designated as safety issue: No ]
- Lower Extremity Self Efficacy Scale [ Time Frame: Intake, 1 week, 4 weeks, 6 months, 1 year, 2 years ] [ Designated as safety issue: No ]
- Positive and Negative Affect Scale [ Time Frame: Intake, 1 week, 4 weeks, 6 months, 1 year, 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 189 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Other: Passive Positioning
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 Name: Manual Therapy
|
|
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.
|
Other: High-Velocity, Low-Amplitude Stretch
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 Name: Manual Therapy
|
|
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.
|
Other: Slow, Mobilization Stretch
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 Name: Manual Therapy
|
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.
Eligibility| Ages Eligible for Study: | 16 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Todd E Davenport, PT, DPT, OCS | (209) 946-3159 | tdavenport@pacific.edu |
| United States, California | |
| Gaspar Physical Therapy | Recruiting |
| Carlsbad, California, United States, 92009 | |
| Contact: Robert Snow 760-634-9750 | |
| Contact: Brian Stone 760-634-9750 | |
| Gaspar Physical Therapy | Recruiting |
| Encinitas, California, United States, 92024 | |
| Contact: Robert Snow 760-634-9750 | |
| Contact: Brian Stone 760-634-9750 | |
| Lodi Physical Therapy | Recruiting |
| Lodi, California, United States, 95242 | |
| Contact: Monty Merrill 209-368-7433 | |
| University of Southern California | Recruiting |
| Los Angeles, California, United States, 90089 | |
| Contact: Todd Davenport, PT, DPT, OCS 209-946-3159 tdavenport@pacific.edu | |
| Sub-Investigator: Kornelia Kulig, PhD, PT | |
| Sub-Investigator: Beth Fisher, PhD, PT | |
| Gaspar Physical Therapy | Recruiting |
| Solana Beach, California, United States, 92075 | |
| Contact: Robert Snow 760-634-9750 | |
| Contact: Brian Stone 760-634-9750 | |
| Pine Street Physical and Occupational Therapy | Recruiting |
| Stockton, California, United States, 95204 | |
| Contact: John Bob 209-463-2800 | |
| United States, Idaho | |
| Therapeutic Associates - Boise at State Street | Recruiting |
| Boise, Idaho, United States, 83702 | |
| Contact: Rob Barnes 208-336-8433 | |
| Therapeutic Associates - Boise at Parkcenter | Recruiting |
| Boise, Idaho, United States, 83706 | |
| Contact: Matt Booth 208-433-9211 | |
| United States, Iowa | |
| Des Moines University Clinic | Recruiting |
| Des Moines, Iowa, United States, 50312 | |
| Contact: Shane McClinton 515-271-1448 | |
| United States, Oregon | |
| Therapeutic Associates - Beaverton Physical Therapy | Recruiting |
| Beaverton, Oregon, United States, 97005 | |
| Contact: Zachary Jones 503-644-3311 | |
| Therapeutic Associates - Athletic Club of Bend | Recruiting |
| Bend, Oregon, United States, 97702 | |
| Contact: Laura Cooper 541-382-7890 | |
| Therapeutic Associates - Redmond | Recruiting |
| Bend, Oregon, United States, 97756 | |
| Contact: Karen Walz 541-923-7494 | |
| Therapeutic Associates - Oregon Medical Group West Eugene Medical Clinic | Recruiting |
| Eugene, Oregon, United States, 97402 | |
| Contact: Hannah Shallice 541-463-2191 | |
| Therapeutic Associates - Oregon Medical Group | Recruiting |
| Eugene, Oregon, United States, 97477 | |
| Contact: Ben Bleazard 541-242-4870 | |
| Therapeutic Associates - Cedar Hills Physical Therapy | Recruiting |
| Portland, Oregon, United States, 97225 | |
| Contact: Kelly Reed 503-292-3583 | |
| Therapeutic Associates - Sherwood Physical Therapy | Recruiting |
| Sherwood, Oregon, United States, 97140 | |
| Contact: Christopher Hoekstra 503-625-1691 | |
| United States, Washington | |
| Therapeutic Associates - Lakemont Physical Therapy | Recruiting |
| Bellevue, Washington, United States, 98006 | |
| Contact: Shana Stratford 425-401-8406 | |
| Contact: Brian Crosier 425-401-8406 | |
| MVP Physical Therapy - Bremerton Clinic | Recruiting |
| Bremerton, Washington, United States, 98310 | |
| Contact: Ashley Court 253-759-4200 | |
| MVP Physical Therapy - Buckley Clinic | Recruiting |
| Buckley, Washington, United States, 98321 | |
| Contact: Ashley Court 253-759-4200 | |
| MVP Physical Therapy - Federal Way Clinic | Recruiting |
| Federal Way, Washington, United States, 98003 | |
| Contact: Ashley Court 253-759-4200 | |
| MVP Physical Therapy - Fife Clinic | Recruiting |
| Fife, Washington, United States, 98424 | |
| Contact: Ashley Court 253-759-4200 | |
| MVP Physical Therapy - Fircrest Clinic | Recruiting |
| Fircrest, Washington, United States, 98466 | |
| Contact: Ashley Court 253-759-4200 | |
| MVP Physical Therapy - Gig Harbor Clinic | Recruiting |
| Gig Harbor, Washington, United States, 98335 | |
| Contact: Ashley Court 253-759-4200 | |
| MVP Physical Therapy - Kirkland Clinic | Recruiting |
| Kirkland, Washington, United States, 98033 | |
| Contact: Ashley Court 253-759-4200 | |
| MVP Physical Therapy - Lacey Clinic | Recruiting |
| Lacey, Washington, United States, 98516 | |
| Contact: Ashley Court 253-759-4200 | |
| MVP Physical Therapy - Lakewood | Recruiting |
| Lakewood, Washington, United States, 98499 | |
| Contact: Boris Gladun 253-582-8142 | |
| Contact: Ashley Court 253-759-4200 | |
| Therapeutic Associates - Liberty Lake Physical Therapy | Recruiting |
| Liberty Lake, Washington, United States, 99019 | |
| Contact: Christine Fletcher 509-891-2258 | |
| Contact: Jeff Bresnahan 509-891-2258 | |
| MVP Physical Therapy - Port Orchard Clinic | Recruiting |
| Port Orchard, Washington, United States, 98367 | |
| Contact: Ashley Court 253-759-4200 | |
| MVP Physical Therapy - Puyallup Clinic | Recruiting |
| Puyallup, Washington, United States, 98371 | |
| Contact: Ashley Court 253-759-4200 | |
| MVP Physical Therapy - Silverdale Clinic | Recruiting |
| Silverdale, Washington, United States, 98383 | |
| Contact: Ashley Court 253-759-4200 | |
| MVP Physical Therapy - Sumner Clinic | Recruiting |
| Sumner, Washington, United States, 98390 | |
| Contact: Ashley Court 253-759-4200 | |
| MVP Physical Therapy - Tacoma Central Clinic | Recruiting |
| Tacoma, Washington, United States, 98405 | |
| Contact: Cuong Pho 253-759-4200 | |
| Contact: Ashley Court 253-759-4200 | |
| Principal Investigator: | Todd E Davenport, PT, DPT, OCS | University of the Pacific |
| Study Director: | Kornelia Kulig, PhD, PT | University of Southern California |
| Study Director: | Beth Fisher, PhD, PT | University of Southern California |
More Information
No publications provided by University of the Pacific
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of the Pacific |
| ClinicalTrials.gov Identifier: | NCT00888498 History of Changes |
| Other Study ID Numbers: | UPacific |
| Study First Received: | April 24, 2009 |
| Last Updated: | August 3, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of the Pacific:
|
Sprains and Strains Ankle Manual Therapies Outcome Studies |
Additional relevant MeSH terms:
|
Sprains and Strains Wounds and Injuries |
ClinicalTrials.gov processed this record on May 16, 2013