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

Ankle Sprains Clinical Trial

Official title:

Effect 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: Recruiting

Administrative data

• NCT number: NCT03428620
• Other study ID #: 511
• Status: Recruiting
• Phase: N/A
• First received: February 5, 2018
• Last updated: April 16, 2018
• Start date: February 14, 2018
• Est. completion date: June 2019

Study information

• Verified date: April 2018
• Source: Shenandoah University
• Contact: Cameron J Bolton, DPT
• Phone: 5405426540
• Email: cbolton16[@]su.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

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

Inclusion and exclusion criterion have been established utilizing the International Ankle Consortium guidelines. Using a convenience sampling, participants will be randomized into the exercise only or mobilization (experimental) and exercise group. Both groups will undergo 12 supervised training sessions across a six-week period. The mobilization (experimental) group will also receive high-velocity-low-amplitude (HVLA) thrust mobilizations at the talocrural, proximal, and distal tibiofibular joints prior to the first three treatment sessions.

An examiner, who is blinded to involved limb and group allocation, will perform a baseline and six-week follow-up examination of joint mobility, range of motion, and functional performance. The participants will complete subjective outcome measures at baseline, 2 weeks, 4 weeks, and 6 weeks including the Foot and Ankle Ability Measurement (FAAM), FAAM-Sport, Ankle Joint Functional Assessment Tool (AJFAT), and the Cumberland Ankle Instability Tool (CAIT). Participants will also complete baseline and 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 will complete this protocol twice a week for six weeks. Treatment sessions will last approximately 30 minutes. Participants will individually progress on particular exercises if zero errors are observed. In addition, all participants will be given a home exercise program (HEP) to complete every day of the week excluding treatment days.

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

Data analysis will be performed using International Business Machines Statistical Package for the Social Sciences (SPSS). Alpha level will be set p<0.05. Expecting to utilize separate 2 x 2 repeated measures analysis of variance (ANOVA) to assess changes in the FAAM, FAAM-Sport, AJFAT, CAIT, figure-of-8 hop test, side hop test, and three directions of the SEBT.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

As adapted from the position statement from the international ankle consortium.

Inclusion Criteria:

• 18-35 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%

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Ankle Injuries
• Ankle Sprains

Intervention

Other:
• High Velocity Low Amplitude mobilization
Mobilizations will be 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	Methodist University	Fayetteville	North Carolina
United States	Shenandoah University	Winchester	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Shenandoah University	Methodist University, North Carolina

Country where clinical trial is conducted

United States, 

References & Publications (4)

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

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. Review. — 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

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
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 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
Primary	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
Primary	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
Primary	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
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 and 6 weeks
Primary	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