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Ankle Sprains and Corticospinal Excitability (ACE)

Primary Purpose

Ankle Sprain

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
High velocity, low amplitude stretch
Slow, mobilization stretch
Passive Positioning
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Ankle Sprain focused on measuring Ankle Sprain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18-60 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%
  • Ankle dorsiflexion range of motion less than or equal to 5 degrees

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
  • Medical conditions that serve as contraindications to mobilization/manipulation and transcranial magnetic stimulation, such as presence of pacemaker, metal in head, pregnancy, neurological disorders, recent use of stimulants or medications known to lower seizure threshold, and personal or family history of seizures

Sites / Locations

  • University of Southern California

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

High velocity, low amplitude stretch

Slow, mobilization stretch

Passive positioning

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.

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, 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.

Outcomes

Primary Outcome Measures

Corticospinal motor excitability (transcranial magnetic stimulation variables)

Secondary Outcome Measures

Single leg squat reach test
Ankle flexibility test (laying on stomach)
Ankle flexibility test (standing against wall)

Full Information

First Posted
January 22, 2009
Last Updated
March 30, 2017
Sponsor
University of Southern California
Collaborators
University of the Pacific, American Physical Therapy Association
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1. Study Identification

Unique Protocol Identification Number
NCT00847769
Brief Title
Ankle Sprains and Corticospinal Excitability
Acronym
ACE
Official Title
Effect of Manual Therapy Intervention on Corticospinal Excitability in Individuals With Post-acute Ankle Sprains
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine changes in the brain associated with improvement in ankle range of motion following ankle manual therapy procedures in individuals with post-acute ankle sprains
Detailed Description
Physical therapists use many ways to treat joints that do not move well. One way takes 1-2 seconds. Another way may take up to 1 minute. Both stretches seem to work, but we do not know how. Certain changes in the brain and spinal cord may cause joints to become more flexible after these kinds of stretches. Right now, we do not have very much information about how these might work in people who have injured their ankle. This study will find out if changes in the brain cause better flexibility in the ankle joint after different kinds of stretches. In this study, subjects with a certain kind of ankle sprains and limited ankle joint flexibility will be assigned to 1 out of 3 groups. Subjects will not get to choose their groups. The first group will have an ankle stretch that lasts 1-2 seconds. The second group will have a stretch that last 1 minute. The third group will have their foot held without any stretching. We will use a machine to stimulate the brain and spinal cord to find out how these stretches affect the brain and spinal cord. The machine sends a magnetic signal to the brain, and we will measure how much signal gets through to the leg muscles using electrodes on the skin. We also will use 3 flexibility tests to find out how well each stretch worked. One test is with the subject lying on their stomach, and the others are with the subject standing up. To start the study, subjects will get their brain stimulated. They will then get their brain stimulated again one hour later. After the second stimulation, subjects will have their flexibility tested and then get 1 of the 3 treatments. After the treatment, subjects will get a last brain stimulation test and flexibility tests. We think subjects that get a fast stretch will have better brain function and flexibility than subjects that get the slow stretch or no stretch. To test our idea, we will compare how each group did with the brain stimulation and flexibility tests. We will also look at the relationship between brain function and flexibility.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Sprain
Keywords
Ankle Sprain

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High velocity, low amplitude stretch
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, mobilization stretch
Arm Type
Active 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. 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.
Arm Title
Passive positioning
Arm Type
Sham 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 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)
Manipulation, GPM-V
Intervention Description
This group (n=9) will receive talocrural traction manipulation. 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)
Articulation, Mobilization, Traction
Intervention Description
This group (n=9) will receive talocrural traction mobilization. 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 investigator'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)
Passive Range of Motion, Placebo
Intervention Description
This group (n=9) will receive the manual therapy control intervention. This will consist of the same patient and clinician preparation for the mobilization/manipulation techniques. However, a single standardized treating investigator will simply maintain passive ankle positioning for the duration of 1 deep inhalation and exhalation by the subject rather than induce an iatrogenic force characteristic of the intervention received by the other 2 comparison groups.
Primary Outcome Measure Information:
Title
Corticospinal motor excitability (transcranial magnetic stimulation variables)
Time Frame
Pre-intervention measurement, 1 additional repeated pre-intervention measurement, post-intervention measurement
Secondary Outcome Measure Information:
Title
Single leg squat reach test
Time Frame
Pre-intervention measurement, 1 additional repeated pre-intervention measurement, post-intervention measurement
Title
Ankle flexibility test (laying on stomach)
Time Frame
Pre-intervention measurement, 1 additional repeated pre-intervention measurement, post-intervention measurement
Title
Ankle flexibility test (standing against wall)
Time Frame
Pre-intervention measurement, 1 additional repeated pre-intervention measurement, post-intervention measurement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-60 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% Ankle dorsiflexion range of motion less than or equal to 5 degrees 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 Medical conditions that serve as contraindications to mobilization/manipulation and transcranial magnetic stimulation, such as presence of pacemaker, metal in head, pregnancy, neurological disorders, recent use of stimulants or medications known to lower seizure threshold, and personal or family history of seizures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beth E Fisher, PhD, PT
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Todd E Davenport, DPT, OCS
Organizational Affiliation
University of the Pacific
Official's Role
Study Director
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27266885
Citation
Fisher BE, Piraino A, Lee YY, Smith JA, Johnson S, Davenport TE, Kulig K. The Effect of Velocity of Joint Mobilization on Corticospinal Excitability in Individuals With a History of Ankle Sprain. J Orthop Sports Phys Ther. 2016 Jul;46(7):562-70. doi: 10.2519/jospt.2016.6602. Epub 2016 Jun 6.
Results Reference
derived
PubMed Identifier
19460169
Citation
Fisher BE, Davenport TE, Kulig K, Wu AD. Identification of potential neuromotor mechanisms of manual therapy in patients with musculoskeletal disablement: rationale and description of a clinical trial. BMC Neurol. 2009 May 21;9:20. doi: 10.1186/1471-2377-9-20.
Results Reference
derived

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Ankle Sprains and Corticospinal Excitability

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