Ankle Sprains and Corticospinal Excitability (ACE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by University of Southern California.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
University of the Pacific
American Physical Therapy Association
Information provided by:
University of Southern California
ClinicalTrials.gov Identifier:
NCT00847769
First received: January 22, 2009
Last updated: February 17, 2009
Last verified: December 2008
  Purpose

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


Condition Intervention Phase
Ankle Sprain
Other: High velocity, low amplitude stretch
Other: Slow, mobilization stretch
Other: Passive Positioning
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of Manual Therapy Intervention on Corticospinal Excitability in Individuals With Post-Acute Ankle Sprains

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • Corticospinal motor excitability (transcranial magnetic stimulation variables) [ Time Frame: Pre-intervention measurement, 1 additional repeated pre-intervention measurement, post-intervention measurement ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Single leg squat reach test [ Time Frame: Pre-intervention measurement, 1 additional repeated pre-intervention measurement, post-intervention measurement ] [ Designated as safety issue: No ]
  • Ankle flexibility test (laying on stomach) [ Time Frame: Pre-intervention measurement, 1 additional repeated pre-intervention measurement, post-intervention measurement ] [ Designated as safety issue: No ]
  • Ankle flexibility test (standing against wall) [ Time Frame: Pre-intervention measurement, 1 additional repeated pre-intervention measurement, post-intervention measurement ] [ Designated as safety issue: No ]

Estimated Enrollment: 27
Study Start Date: December 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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: High velocity, low amplitude stretch
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.
Other Names:
  • Manipulation
  • GPM-V
Active Comparator: 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: Slow, mobilization stretch
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.
Other Names:
  • Articulation
  • Mobilization
  • Traction
Sham Comparator: 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: Passive Positioning
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.
Other Names:
  • Passive Range of Motion
  • Placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00847769

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

Locations
United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90089
Contact: Beth E Fisher, PhD, PT       bfisher@usc.edu   
Contact: Todd E Davenport, DPT, OCS    (209) 946-3159    tdavenport@pacific.edu   
Principal Investigator: Beth E Fisher, PhD, PT         
Sub-Investigator: Todd E Davenport, DPT, OCS         
Sub-Investigator: Kornelia Kulig, PhD, PT         
Sponsors and Collaborators
University of Southern California
University of the Pacific
American Physical Therapy Association
Investigators
Principal Investigator: Beth E Fisher, PhD, PT University of Southern California
Study Director: Todd E Davenport, DPT, OCS University of the Pacific
  More Information

No publications provided by University of Southern California

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Beth Fisher, University of Southern California
ClinicalTrials.gov Identifier: NCT00847769     History of Changes
Other Study ID Numbers: HS-08-00192
Study First Received: January 22, 2009
Last Updated: February 17, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Southern California:
Ankle Sprain

Additional relevant MeSH terms:
Sprains and Strains
Ankle Injuries
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on April 14, 2014