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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Functional Deficits, Manipulation, Rehabilitation

Intervention / Treatment
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* Other: High Velocity Low Amplitude mobilization
* Other: Exercise Protocol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobilization<br>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<br>* Mobilizations were performed one time at each joint, prior to completing the exercise protocol during the first three treatment sessions.<br>* Other names: thrust mobilization;Other: Exercise Protocol<br>* This exercise regimen is a modified version of the balance training program described by McKeon et al.<br>* Other names: Control;|
| Active Comparator: Exercise Protocol<br>This exercise regimen is a modified version of the balance training program described by McKeon et al. | Other: Exercise Protocol<br>* This exercise regimen is a modified version of the balance training program described by McKeon et al.<br>* Other names: Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |