Effect of Mobilization in Conjunction With Exercise in Participants With a History of Chronic Ankle Instability

NCT03428620 | Unknown

• 1 other identifier: 511
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

Our purpose is to examine the combined effects of thrust mobilization of the ankle joints in conjunction with a six-week rehabilitation program on functional performance in subjects reporting chronic ankle instability (CAI).

Conditions

Ankle Sprains

Keywords

Functional Performance; Rehabilitation; Manipulation

Outcome Measures

Primary Outcomes (7)

• Change in baseline Figure-of-8 hop test at 6 weeks.

  The participant begins the test on either side of a demarcated 5-meter distance. While standing on the involved ankle, the participant is instructed to "hop on one foot, as fast as you can," twice around the figure 8. Two trials will be performed with the fastest time being recorded.

  Baseline and 6 weeks

• Change in baseline Side hop test at 6 weeks

  The participant stands on the involved limb on either side of two lines that are 30 cm apart. They are then instructed to "hop on one foot, as fast as you can," laterally and then back to the starting position. This is counted as two repetitions and 10 repetitions are performed. If the participant lands on or between the lines, this repetition does not count and they continue until 10 good repetitions are completed. Participants perform two trials and the fastest time is recorded.

  Baseline and 6 weeks

• Change in baseline Star Excursion Balance Test (SEBT) at 6 weeks

  Each participant is asked to maintain single-limb stance, with hands on their hips, while reaching in anterior, posteromedial, and posterolateral directions.

  Baseline and 6 weeks

• Change in baseline Foot and Ankle Ability Measure (FAAM)- Activities of Daily Living (ADL) Subscale at 6 weeks

  The FAAM- ADL is a 21-item tool that is designed to assess functional limitations related to foot and ankle conditions. Each item is scored on a Likert scale; 0 (unable to do) to 4 (no difficulty) and has total point value of 84 points, reported as a percent value.

  Baseline and 6 weeks

• Change in baseline Foot and Ankle Ability Measure (FAAM)- Sport subscale at 6 weeks

  The FAAM- Sport is a 7-item tool that is a sub-scale of the FAAM. Each item is scored on a Likert scale; 0 (unable to do) to 4 (no difficulty) with a total point value of 28 points, reported as a percent value.

  Baseline and 6 weeks

• Change in baseline Ankle Joint Functional Assessment Tool (AJFAT) at 6 weeks

  12-item tool that rates the participant's overall perceived level of function. Each item is assigned a point value from 0 (much less than other ankle) to 4 (much more than other ankle) with a possible total value of 48 points.

  Baseline and 6 weeks

• Change in baseline Cumberland Ankle Instability Tool (CAIT) at 6 weeks.

  9-item questionnaire that helps discriminate and measure the severity of functional ankle instability.

  Baseline and 6 weeks

Study Arms (2)

Mobilization

EXPERIMENTAL

High Velocity Low Amplitude mobilization group. The three joints that will be manipulated include proximal tibiofibular, the distal tibiofibular, and talocrural joints and will be mobilized the first three sessions prior to the participants performing the exercise protocol.

Other: High Velocity Low Amplitude mobilization; Other: Exercise protocol

Exercise Protocol

ACTIVE COMPARATOR

This exercise regimen is a modified version of the balance training program described by McKeon et al.

Other: Exercise protocol

Interventions

High Velocity Low Amplitude mobilization OTHER

Mobilizations will be performed one time at each joint, prior to completing the exercise protocol during the first three treatment sessions.

Also known as: HVLA, thrust mobilization

Mobilization

Exercise protocol OTHER

This exercise regimen is a modified version of the balance training program described by McKeon et al.

Exercise Protocol; Mobilization

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years of age
• A history of at least 1 significant ankle sprain (The initial sprain must have occurred at least 12 months prior to study enrollment, associated with inflammatory symptoms (pain, swelling, etc), created at least 1 interrupted day of desired physical activity)
• The most recent injury must have occurred more than 3 months prior to study enrollment.
• A history of the previously injured ankle joint "giving way" and/or recurrent sprain and/or "feelings of instability."
• Cumberland Ankle Instability Tool (CAIT) \< 24
• Foot and Ankle Ability Measure (FAAM)42: ADL scale \< 90%, Sport scale \< 80%

You may not qualify if:

• A history of previous surgeries to the musculoskeletal structures (ie, bones, joint structures, nerves) in either limb of the lower extremity.
• A history of a fracture in either limb of the lower extremity requiring realignment
• Acute injury to musculoskeletal structures of other joints of the lower extremity in the previous 3 months, which impacted joint integrity and function (ie, sprains, fractures) resulting in at least 1 interrupted day of desired physical activity

Sponsors & Collaborators

• Shenandoah University: lead
• Methodist University, North Carolina: collaborator

Study Sites (2)

Methodist University

Fayetteville, North Carolina, 28311, United States

RECRUITING

Shenandoah University

Winchester, Virginia, 22601, United States

RECRUITING

Related Publications (4)

• Gribble PA, Delahunt E, Bleakley CM, Caulfield B, Docherty CL, Fong DT, Fourchet F, Hertel J, Hiller CE, Kaminski TW, McKeon PO, Refshauge KM, van der Wees P, Vicenzino W, Wikstrom EA. Selection criteria for patients with chronic ankle instability in controlled research: a position statement of the International Ankle Consortium. J Athl Train. 2014 Jan-Feb;49(1):121-7. doi: 10.4085/1062-6050-49.1.14. Epub 2013 Dec 30.

  PMID: 24377963 BACKGROUND

• McKeon PO, Ingersoll CD, Kerrigan DC, Saliba E, Bennett BC, Hertel J. Balance training improves function and postural control in those with chronic ankle instability. Med Sci Sports Exerc. 2008 Oct;40(10):1810-9. doi: 10.1249/MSS.0b013e31817e0f92.

  PMID: 18799992 BACKGROUND

• Hale SA, Hertel J, Olmsted-Kramer LC. The effect of a 4-week comprehensive rehabilitation program on postural control and lower extremity function in individuals with chronic ankle instability. J Orthop Sports Phys Ther. 2007 Jun;37(6):303-11. doi: 10.2519/jospt.2007.2322.

  PMID: 17612356 BACKGROUND

• Beazell JR, Grindstaff TL, Sauer LD, Magrum EM, Ingersoll CD, Hertel J. Effects of a proximal or distal tibiofibular joint manipulation on ankle range of motion and functional outcomes in individuals with chronic ankle instability. J Orthop Sports Phys Ther. 2012 Feb;42(2):125-34. doi: 10.2519/jospt.2012.3729. Epub 2012 Feb 1.

  PMID: 22333567 BACKGROUND

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Officials

• Cameron J Bolton, DPT

  Shenandoah University

  PRINCIPAL INVESTIGATOR

• Sheri Hale, PhD, PT

  Shenandoah University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cameron J Bolton, DPT

CONTACT

5405426540; cbolton16@su.edu

Sheri Hale, PhD, PT

CONTACT

5405457240; shale2@su.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Division of Physical Therapy

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: February 9, 2018
• Study Start: February 14, 2018
• Primary Completion: January 1, 2019
• Study Completion: June 1, 2019
• Last Updated: April 17, 2018

Record last verified: 2018-04

Locations

US (2)