Clinical trial NCT02945943: Effects of Mobilization in Conjunction With Therapeutic Exercise in Participants With a History of Ankle Sprain
Official title: Effects of a Six-week Rehabilitation Program in Conjunction With Thrust Mobilization on Lower Extremity Function in Subjects Reporting Chronic Ankle Instability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Deficits
Manipulation
Rehabilitation
Lead sponsor: Shenandoah University
Sponsor class: OTHER
First posted: 2016-10-26
Enrollment: 19
Sex: ALL
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in baseline Figure-of-8 hop test at 6 weeks.
timeFrame: Baseline and 6 weeks
measure: Change in baseline Side hop test at 6 weeks.
timeFrame: Baseline and 6 weeks
measure: Change in baseline Star Excursion Balance Test (SEBT) at 6 weeks.
timeFrame: Baseline and 6 weeks
measure: Change in baseline Functional Ankle Disability Index (FADI) at 6 weeks.
timeFrame: Baseline, 2 week, 4 weeks, 6 weeks
measure: Change in baseline Functional Ankle Disability Index (FADI)- Sport at 6 weeks.
timeFrame: Baseline, 2 week, 4 weeks, 6 weeks
measure: Change in baseline Ankle Joint Functional Assessment Tool (AJFAT) at 6 weeks.
timeFrame: Baseline, 2 week, 4 weeks, 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Winchester
country: United States
facility: Shenandoah University Division of Physical Therapy
state: Virginia
Study officials:
affiliation: Shenandoah University Division of Physical Therapy
name: Cameron R Jones, DPT
role: PRINCIPAL_INVESTIGATOR
affiliation: Shenandoah University Division of Physical Therapy
name: Sheri Hale, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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