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Ankle Manual Therapy for Ankle Sprains (AMT)

Primary Purpose

Sprains and Strains

Status
Suspended
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Passive Positioning
High-Velocity, Low-Amplitude Stretch
Slow, Mobilization Stretch
Sponsored by
University of the Pacific
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sprains and Strains focused on measuring Sprains and Strains, Ankle, Manual Therapies, Outcome Studies

Eligibility Criteria

16 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of the Pacific

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Hands-On Control

Fast Stretching

Slow Stretching

Arm Description

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. 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. 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.

Outcomes

Primary Outcome Measures

Foot and Ankle Ability Measure

Secondary Outcome Measures

Patient Global Rating of Improvement
Modified Fear Avoidance Beliefs Questionnaire
Lower Extremity Self Efficacy Scale
Positive and Negative Affect Scale

Full Information

First Posted
April 24, 2009
Last Updated
July 1, 2015
Sponsor
University of the Pacific
Collaborators
University of Southern California, American Physical Therapy Association
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1. Study Identification

Unique Protocol Identification Number
NCT00888498
Brief Title
Ankle Manual Therapy for Ankle Sprains
Acronym
AMT
Official Title
Ankle Manual Therapy for Individuals With Post-Acute Ankle Sprains: A Randomized, Placebo-Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Suspended
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of the Pacific
Collaborators
University of Southern California, American Physical Therapy Association

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sprains and Strains
Keywords
Sprains and Strains, Ankle, Manual Therapies, Outcome Studies

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
189 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hands-On Control
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Fast Stretching
Arm Type
Experimental
Arm Description
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.
Arm Title
Slow Stretching
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Passive Positioning
Other Intervention Name(s)
Manual Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
High-Velocity, Low-Amplitude Stretch
Other Intervention Name(s)
Manual Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Slow, Mobilization Stretch
Other Intervention Name(s)
Manual Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Foot and Ankle Ability Measure
Time Frame
Intake, 1 week, 4 weeks, 6 months, 1 year, 2 years
Secondary Outcome Measure Information:
Title
Patient Global Rating of Improvement
Time Frame
Intake, 1 week, 4 weeks, 6 months, 1 year, 2 years
Title
Modified Fear Avoidance Beliefs Questionnaire
Time Frame
Intake, 1 week, 4 weeks, 6 months, 1 year, 2 years
Title
Lower Extremity Self Efficacy Scale
Time Frame
Intake, 1 week, 4 weeks, 6 months, 1 year, 2 years
Title
Positive and Negative Affect Scale
Time Frame
Intake, 1 week, 4 weeks, 6 months, 1 year, 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd E Davenport, PT, DPT, OCS
Organizational Affiliation
University of the Pacific
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kornelia Kulig, PhD, PT
Organizational Affiliation
University of Southern California
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Beth Fisher, PhD, PT
Organizational Affiliation
University of Southern California
Official's Role
Study Director
Facility Information:
Facility Name
University of the Pacific
City
Stockton
State/Province
California
ZIP/Postal Code
95219
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20958995
Citation
Davenport TE, Kulig K, Fisher BE. Ankle manual therapy for individuals with post-acute ankle sprains: description of a randomized, placebo-controlled clinical trial. BMC Complement Altern Med. 2010 Oct 19;10:59. doi: 10.1186/1472-6882-10-59.
Results Reference
derived

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Ankle Manual Therapy for Ankle Sprains

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