Effects of Mobilization in Conjunction With Therapeutic Exercise in Participants With a History of Ankle Sprain

NCT02945943 | Completed

• 1 other identifier: 12-1627
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Our purpose was to examine the combined effects of thrust mobilization of the proximal and distal ankle joints in conjunction with a six-week rehabilitation program on ankle function in subjects reporting chronic ankle instability (CAI).

Conditions

Functional Deficits; Manipulation; Rehabilitation

Outcome Measures

Primary Outcomes (6)

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

  The participant began the test on either side of a demarcated 5-meter distance. While standing on the involved ankle, the participant was instructed to "hop on one foot, as fast as you can," twice around the figure 8. Two trials were 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 were then instructed to "hop on one foot, as fast as you can," laterally and then back to the starting position. This was counted as two repetitions and 10 repetitions were performed. If the participant landed on or between the lines, this repetition was not counted and they continued until 10 good repetitions were completed. Participants performed two trials and the fastest time was recorded.

  Baseline and 6 weeks

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

  Each participant was 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 Functional Ankle Disability Index (FADI) at 6 weeks.

  The FADI is a 26-item tool that is designed to assess functional limitations related to foot and ankle conditions. Each item is scored from 0 (unable to do) to 4 (no difficulty at all) and has total point value of 104 points.

  Baseline, 2 week, 4 weeks, 6 weeks

• Change in baseline Functional Ankle Disability Index (FADI)- Sport at 6 weeks.

  The FADI-Sport is an 8-item tool that is a sub-scale of the FADI. Each item is scored with from 0 (unable to do) to 4 with a total point value of 32 points, reported as a percent value.

  Baseline, 2 week, 4 weeks, 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, 2 week, 4 weeks, 6 weeks

Study Arms (2)

Mobilization

EXPERIMENTAL

High Velocity Low Amplitude mobilization group. The three joints manipulated included proximal tibiofibular, the distal tibiofibular, and talocrural joints and were 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 were 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.

Also known as: Control

Exercise Protocol; Mobilization

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• to 35 years old age
• Self-reported history of an ankle sprain
• Reports of "giving way" or a "loose" ankle within the past 6 months and/or decrease in functional status as compared to the uninvolved ankle

You may not qualify if:

• Lower extremity injury within the past 3 months
• History of vestibular dysfunction, neuromuscular diagnosis, mental illness, or if the participant was currently participating in another supervised rehabilitation program for the involved ankle.

Sponsors & Collaborators

• Shenandoah University: lead

Study Sites (1)

Shenandoah University Division of Physical Therapy

Winchester, Virginia, 22601, United States

Location

Related Publications (12)

• 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

• Waterman BR, Owens BD, Davey S, Zacchilli MA, Belmont PJ Jr. The epidemiology of ankle sprains in the United States. J Bone Joint Surg Am. 2010 Oct 6;92(13):2279-84. doi: 10.2106/JBJS.I.01537.

  PMID: 20926721 BACKGROUND

• Hertel J. Sensorimotor deficits with ankle sprains and chronic ankle instability. Clin Sports Med. 2008 Jul;27(3):353-70, vii. doi: 10.1016/j.csm.2008.03.006.

  PMID: 18503872 BACKGROUND

• Wikstrom EA, Hubbard TJ. Talar positional fault in persons with chronic ankle instability. Arch Phys Med Rehabil. 2010 Aug;91(8):1267-71. doi: 10.1016/j.apmr.2010.04.022.

  PMID: 20684909 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

• Hupperets MD, Verhagen EA, van Mechelen W. Effect of unsupervised home based proprioceptive training on recurrences of ankle sprain: randomised controlled trial. BMJ. 2009 Jul 9;339:b2684. doi: 10.1136/bmj.b2684.

  PMID: 19589822 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

• Hubbard TJ, Hertel J. Anterior positional fault of the fibula after sub-acute lateral ankle sprains. Man Ther. 2008 Feb;13(1):63-7. doi: 10.1016/j.math.2006.09.008. Epub 2006 Dec 26.

  PMID: 17188923 BACKGROUND

• Denegar CR, Hertel J, Fonseca J. The effect of lateral ankle sprain on dorsiflexion range of motion, posterior talar glide, and joint laxity. J Orthop Sports Phys Ther. 2002 Apr;32(4):166-73. doi: 10.2519/jospt.2002.32.4.166.

  PMID: 11949665 BACKGROUND

• Grindstaff TL, Beazell JR, Sauer LD, Magrum EM, Ingersoll CD, Hertel J. Immediate effects of a tibiofibular joint manipulation on lower extremity H-reflex measurements in individuals with chronic ankle instability. J Electromyogr Kinesiol. 2011 Aug;21(4):652-8. doi: 10.1016/j.jelekin.2011.03.011. Epub 2011 May 4.

  PMID: 21546263 BACKGROUND

• Whitman JM, Childs JD, Walker V. The use of manipulation in a patient with an ankle sprain injury not responding to conventional management: a case report. Man Ther. 2005 Aug;10(3):224-31. doi: 10.1016/j.math.2004.10.003. Epub 2005 Jan 21. No abstract available.

  PMID: 16038858 BACKGROUND

• Bialosky JE, Bishop MD, Price DD, Robinson ME, George SZ. The mechanisms of manual therapy in the treatment of musculoskeletal pain: a comprehensive model. Man Ther. 2009 Oct;14(5):531-8. doi: 10.1016/j.math.2008.09.001. Epub 2008 Nov 21.

  PMID: 19027342 BACKGROUND

Study Officials

• Cameron R Jones, DPT

  Shenandoah University Division of Physical Therapy

  PRINCIPAL INVESTIGATOR

• Sheri Hale, PhD, PT

  Shenandoah University Division of Physical Therapy

  PRINCIPAL INVESTIGATOR

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: October 24, 2016
• First Posted: October 26, 2016
• Study Start: February 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: October 26, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)