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

Rehabilitation Clinical Trial

Official title:

Effects of a Six-week Rehabilitation Program in Conjunction With Thrust Mobilization on Lower Extremity Function in Subjects Reporting Chronic Ankle Instability

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02945943
• Other study ID #: 12-1627
• Status: Completed
• Phase: N/A
• First received: October 24, 2016
• Last updated: October 24, 2016
• Start date: February 2012
• Est. completion date: October 2013

Study information

• Verified date: October 2016
• Source: Shenandoah University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Description:

Joint mobilizations are reported to increase range of motion (ROM), postural control and proprioception, and decrease pain in individuals with CAI. There is no research supporting the combined effects of thrust mobilization and exercise on function in this population.

Inclusion and exclusion criterion were established and a convenience sample was performed. 19 subjects were randomized into the exercise only or mobilization (experimental) and exercise group. Both groups underwent 12 supervised training sessions across a six-week period. The mobilization (experimental) group also received high-velocity-low-amplitude (HVLA) thrust mobilizations at the talocrural, proximal, and distal tibiofibular joints prior to the first three treatment sessions.

An examiner blinded to involved limb and group allocation performed a baseline and six-week follow-up examination of muscle strength, joint mobility, range of motion, and/or functional performance. The participants completed subjective outcome measures at baseline, 2 weeks, 4 weeks, and finally at 6 weeks including the Functional Ankle Disability Index (FADI), FADI-Sport, and the Ankle Joint Functional Assessment Tool (AJFAT). Participants also completed baseline and a six-week follow up assessments of the figure-of-8 hop test, side hop test, and three directions of the Star Excursion Balance test (SEBT).

The exercise protocol is a modified version of the balance training program described by McKeon et al. Participants completed this protocol twice a week, for six weeks. Treatment sessions lasted approximately 30 minutes. Participants were individually progressed on particular exercises if zero errors were observed. In addition, all participants were given a home exercise program (HEP) to complete every day of the week excluding treatment days.

The mobilization (experimental) group received HVLA thrust mobilizations at the three joints stated above for the first three sessions prior to completing the exercise protocol. Each mobilization was performed one time at each joint. The order of joint mobilizations was randomized prior to administering.

Data analysis was performed using International Business Machines Statistical Package for the Social Sciences (SPSS) version (22). Alpha level was set p<0.05. Separate 2 x 2 repeated measures analysis of variance (ANOVA) were used to assess changes in the FADI, FADI-Sport, figure-of-8 hop test, side hop test, and three directions of the SEBT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 35 Years

Eligibility

Inclusion Criteria:

• 16 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

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Functional Deficits
• Manipulation
• Rehabilitation

Intervention

Other:
• High Velocity Low Amplitude mobilization
Mobilizations were performed one time at each joint, prior to completing the exercise protocol during the first three treatment sessions.
• Exercise Protocol
This exercise regimen is a modified version of the balance training program described by McKeon et al.

Locations

Country	Name	City	State
United States	Shenandoah University Division of Physical Therapy	Winchester	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Shenandoah University

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Hubbard TJ, Hertel J. Anterior positional fault of the fibula after sub-acute lateral ankle sprains. Man Ther. 2008 Feb;13(1):63-7. Epub 2006 Dec 26. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2005 Jan 21. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No