Clinical trial NCT01790581: Balance Training vs. Balance Training w/ STARS
Official title: Balance Training vs. Balance Training w/ STARS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle (Ligaments); Instability (Old Injury)
Keywords: Chronic Ankle Instability
Lead sponsor: University of North Carolina, Charlotte
Sponsor class: OTHER
Collaborators: name: Mid-Atlantic Athletic Trainers' Association
First posted: 2013-02-13
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Chronic Ankle Instability (CAI) is a health condition that results in repeated ankle sprains and other residual impairments. CAI has been linked to many different causative factors including sensory and motor deficits that affect the global function of the sensorimotor system as well as the patient. Over the past 20 years, strong evidence has been generated to support balance training as an effective intervention strategy in the CAI population. Unfortunately, most investigations have focused solely on maximizing motor output through balance training, while ignoring the full spectrum of sensorimotor dysfunction associated with CAI. There may be advantageous sensory-targeted interventions that augment the effects of balance training and lead to greater enhancements of functional outcomes for CAI. However, this possibility has not been systematically explored. Sensory-targeted ankle rehabilitation strategies (STARS), such as joint mobilization and plantar massage have resulted in improved sensorimotor function in those with CAI. However, only a single STARS (i.e. stochastic resonance) has been investigated in combination with balance training. While the combined effects were greater than those of balance training alone, stochastic resonance requires relatively expensive equipment that is not commercially available. Thus, the purpose of this investigation is to test the hypothesis that combining low cost STARS (e.g. plantar massage and joint mobilizations) with balance training will result in greater sensorimotor and functional improvements in those with CAI than balance training alone.


Eligibility criteria: Inclusion Criteria:

* Males and females between the ages of 18 and 35.
* A history of at least one episode of "giving way" within the past 3 months.
* Answering 4 or more questions of "Yes" on the Ankle Instability Instrument (AII).
* Score of \<90% on the self-reported Foot and Ankle Ability Measure (FAAM).
* Score of \<80% on the FAAM Sport.

Exclusion Criteria:

* Failing to meet the inclusion criteria.
* Known balance and vision problems.
* Acute lower extremities and head injuries that occurred \<6 weeks ago.
* Chronic musculoskeletal conditions known to affect balance.
* A history of ankle surgeries to fix internal derangements.

Primary outcomes:
measure: Balance
timeFrame: Balance at 1-day post intervention
measure: Self-assessed Disability
timeFrame: Disability to 1-day post intervention
Secondary outcomes:
measure: Balance
timeFrame: Change from baseline balance at 1-week post intervention
measure: Self-assessed Disability
timeFrame: Change from baseline disability at 1-week post intervention
measure: Self-assessed Disability
timeFrame: Change from baseline disability at 1-month post intervention
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: University of North Carolina at Charlotte
state: North Carolina
Study officials:
affiliation: University of North Carolina at Charlotte
name: Erik A Wikstrom, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.