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Clinical Trials/NCT01790581
NCT01790581
Completed
Not Applicable

Balance Training vs. Balance Training w/ STARS

University of North Carolina, Charlotte1 site in 1 country24 target enrollmentJanuary 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ankle (Ligaments); Instability (Old Injury)
Sponsor
University of North Carolina, Charlotte
Enrollment
24
Locations
1
Primary Endpoint
Balance
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
December 2014
Last Updated
8 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Sponsor
University of North Carolina, Charlotte
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Males and females between the ages of 18 and
  • 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.

Outcomes

Primary Outcomes

Balance

Time Frame: Balance at 1-day post intervention

Dynamic balance will be assessed with the Star Excursion Balance Test (SEBT). This test requires a person to maintain their balance on a single limb while reaching as far as they can (with their other leg) in 3 different directions (forward, back-left, and back-right).

Self-assessed Disability

Time Frame: Disability to 1-day post intervention

2 questionnaires regarding self-assessed disability during activities of daily living and sport will be completed. The questionnaires will include the Foot and Ankle Ability Measure, and the Foot and Ankle Ability Measure-Sport. The FAAM contains 21 activity related items (max score of 84) while the FAAM-S contains 8 activity related items (max score of 32). Lower percentages (patient's score divided by max score) represent greater disability, and both FAAM and FAAM-S scores have been found to be reliable and precise (r=0.89, SEM= 2.1 and r=0.87, SEM= 4.5, respectively) in people with CAI.

Secondary Outcomes

  • Balance(Change from baseline balance at 1-week post intervention)
  • Self-assessed Disability(Change from baseline disability at 1-month post intervention)

Study Sites (1)

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