Ankle Sprains and Corticospinal Excitability

NCT00847769 | Completed Phase 1

• 1 other identifier: HS-08-00192
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Conditions

Ankle Sprain

Keywords

Ankle Sprain

Outcome Measures

Primary Outcomes (1)

• Corticospinal motor excitability (transcranial magnetic stimulation variables)

  Pre-intervention measurement, 1 additional repeated pre-intervention measurement, post-intervention measurement

Secondary Outcomes (3)

• 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

Study Arms (3)

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

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

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

Interventions

High velocity, low amplitude stretch OTHER

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.

Also known as: Manipulation, GPM-V

High velocity, low amplitude stretch

Slow, mobilization stretch OTHER

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.

Also known as: Articulation, Mobilization, Traction

Slow, mobilization stretch

Passive Positioning OTHER

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.

Also known as: Passive Range of Motion, Placebo

Passive positioning

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• University of the Pacific: collaborator
• American Physical Therapy Association: collaborator

Study Sites (1)

University of Southern California

Los Angeles, California, 90089, United States

Location

Related Publications (2)

• 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.

  PMID: 27266885 DERIVED

• 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.

  PMID: 19460169 DERIVED

MeSH Terms

Conditions

Ankle Injuries

Interventions

Traction; Range of Motion, Articular

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Surgical Procedures, Operative; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Beth E Fisher, PhD, PT

  University of Southern California

  PRINCIPAL INVESTIGATOR

• Todd E Davenport, DPT, OCS

  University of the Pacific

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Principal Investigator

Study Record Dates

• First Submitted: January 22, 2009
• First Posted: February 19, 2009
• Study Start: December 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: April 4, 2017

Record last verified: 2017-03

Locations

US (1)