Ankle Sprains and Corticospinal Excitability - Full Text View

Sponsors and Collaborators:	University of Southern California University of the Pacific Orthopaedic Section, American Physical Therapy Association
Information provided by:	University of Southern California
ClinicalTrials.gov Identifier:	NCT00847769

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 I Phase II

U.S. FDA Resources

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

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
High velocity, low amplitude stretch: Experimental 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.
Slow, mobilization stretch: Active Comparator 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.
Passive positioning: Sham Comparator 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.

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

Orthopaedic Section, 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

Responsible Party:	University of Southern California ( Beth Fisher )
Study ID Numbers:	HS-08-00192
Study First Received:	January 22, 2009
Last Updated:	February 17, 2009
ClinicalTrials.gov Identifier:	NCT00847769 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Southern California:

Ankle Sprain

Study placed in the following topic categories:

Benzocaine
Wounds and Injuries
Disorders of Environmental Origin
Sprains and Strains

Additional relevant MeSH terms:

Wounds and Injuries
Disorders of Environmental Origin
Sprains and Strains

ClinicalTrials.gov processed this record on May 07, 2009