Ankle Sprains and Corticospinal Excitability (ACE)

Effect of Manual Therapy Intervention on Corticospinal Excitability in Individuals With Post-acute Ankle Sprains

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

Study Overview

• Status: Completed
• Conditions: Ankle Sprain
• Intervention / Treatment: Other: High velocity, low amplitude stretch; Other: Slow, mobilization stretch; Other: Passive Positioning

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90089
      • University of Southern California

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Mobilization; Articulation; 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: Placebo; Passive Range of Motion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Corticospinal motor excitability (transcranial magnetic stimulation variables)	Pre-intervention measurement, 1 additional repeated pre-intervention measurement, post-intervention measurement

Secondary Outcome Measures

Outcome Measure	Time Frame
Single leg squat reach test	Pre-intervention measurement, 1 additional repeated pre-intervention measurement, post-intervention measurement
Ankle flexibility test (laying on stomach)	Pre-intervention measurement, 1 additional repeated pre-intervention measurement, post-intervention measurement
Ankle flexibility test (standing against wall)	Pre-intervention measurement, 1 additional repeated pre-intervention measurement, post-intervention measurement

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: American Physical Therapy Association; University of the Pacific
• Investigators: Principal Investigator: Beth E Fisher, PhD, PT, University of Southern California; Study Director: Todd E Davenport, DPT, OCS, University of the Pacific

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: January 22, 2009
• First Submitted That Met QC Criteria: February 17, 2009
• First Posted (Estimate): February 19, 2009

Study Record Updates

• Last Update Posted (Actual): April 4, 2017
• Last Update Submitted That Met QC Criteria: March 30, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Ankle Sprain
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Sprains and Strains; Ankle Injuries
• Other Study ID Numbers: HS-08-00192