Clinical trial NCT00847769: Ankle Sprains and Corticospinal Excitability
Official title: Effect of Manual Therapy Intervention on Corticospinal Excitability in Individuals With Post-acute Ankle Sprains
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Ankle Sprain
Keywords: Ankle Sprain
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: University of the Pacific
name: American Physical Therapy Association
First posted: 2009-02-19
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Corticospinal motor excitability (transcranial magnetic stimulation variables)
timeFrame: Pre-intervention measurement, 1 additional repeated pre-intervention measurement, post-intervention measurement
Secondary outcomes:
measure: Single leg squat reach test
timeFrame: Pre-intervention measurement, 1 additional repeated pre-intervention measurement, post-intervention measurement
measure: Ankle flexibility test (laying on stomach)
timeFrame: Pre-intervention measurement, 1 additional repeated pre-intervention measurement, post-intervention measurement
measure: Ankle flexibility test (standing against wall)
timeFrame: Pre-intervention measurement, 1 additional repeated pre-intervention measurement, post-intervention measurement
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Beth E Fisher, PhD, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: University of the Pacific
name: Todd E Davenport, DPT, OCS
role: STUDY_DIRECTOR
References:
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.
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.