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Clinical Trials/NCT02945943
NCT02945943
Completed
Not Applicable

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

Shenandoah University1 site in 1 country19 target enrollmentFebruary 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Functional Deficits
Sponsor
Shenandoah University
Enrollment
19
Locations
1
Primary Endpoint
Change in baseline Functional Ankle Disability Index (FADI) at 6 weeks.
Status
Completed
Last Updated
9 years ago

Overview

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).

Detailed 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.

Registry
clinicaltrials.gov
Start Date
February 2012
End Date
October 2013
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Cameron Jones

Assistant Professor Division of Physical Therapy

Shenandoah University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Time Frame: Baseline, 2 week, 4 weeks, 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.

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

Time Frame: Baseline and 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.

Change in baseline Side hop test at 6 weeks.

Time Frame: Baseline and 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.

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

Time Frame: Baseline and 6 weeks

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

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

Time Frame: Baseline, 2 week, 4 weeks, 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.

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

Time Frame: Baseline, 2 week, 4 weeks, 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.

Study Sites (1)

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