Ankle Manual Therapy for Ankle Sprains (AMT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 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: June 11, 2013
Last verified: June 2013
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
University of the Pacific Recruiting
Stockton, California, United States, 95219
Contact: Todd E Davenport, PT, DPT, OCS    209-946-3159    tdavenport@pacific.edu   
Principal Investigator: Todd E Davenport, PT, DPT, OCS         
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: June 11, 2013
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
Ankle Injuries
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on July 29, 2014