Trial record 1 of 48 for:    Open Studies | "Sprains and Strains"
Previous Study | Return to List | Next Study

Ankle Manual Therapy for Ankle Sprains (AMT)

This study is currently recruiting participants.
Verified August 2012 by University of the Pacific
Sponsor:
Collaborators:
University of Southern California
American Physical Therapy Association
Information provided by (Responsible Party):
University of the Pacific
ClinicalTrials.gov Identifier:
NCT00888498
First received: April 24, 2009
Last updated: August 3, 2012
Last verified: August 2012
  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

Resource links provided by NLM:


Further study details as provided by University of the Pacific:

Primary Outcome Measures:
  • Foot and Ankle Ability Measure [ Time Frame: Intake, 1 week, 4 weeks, 6 months, 1 year, 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00888498

Contacts
Contact: Todd E Davenport, PT, DPT, OCS (209) 946-3159 tdavenport@pacific.edu

Locations
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        
Sponsors and Collaborators
University of the Pacific
University of Southern California
American Physical Therapy Association
Investigators
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 21, 2013