Balance Training vs. Balance Training w/ STARS

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of North Carolina, Charlotte
Sponsor:
Collaborator:
Mid-Atlantic Athletic Trainers' Association
Information provided by (Responsible Party):
Erik Wikstrom, PhD, ATC, University of North Carolina, Charlotte
ClinicalTrials.gov Identifier:
NCT01790581
First received: February 8, 2013
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Ankle (Ligaments); Instability (Old Injury)
Behavioral: Balance Training
Behavioral: STARS

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Balance Training vs. Balance Training w/ STARS

Further study details as provided by University of North Carolina, Charlotte:

Primary Outcome Measures:
  • Balance [ Time Frame: Change from baseline balance at 1-day post intervention ] [ Designated as safety issue: No ]
    Static balance will be assessed under 3 conditions: Single limb stance on a force plate with: eyes open, eyes closed, and while counting backwards by 7s (with eyes open).er single and dual-task conditions. 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).

  • Balance [ Time Frame: Change from baseline balance at 1-week post intervention ] [ Designated as safety issue: No ]
    Static balance will be assessed under 3 conditions: Single limb stance on a force plate with: eyes open, eyes closed, and while counting backwards by 7s (with eyes open).er single and dual-task conditions. 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).


Secondary Outcome Measures:
  • Self-assessed disability [ Time Frame: Change from baseline disability to 1-day post intervention ] [ Designated as safety issue: No ]
    3 questionnaires regarding self-assessed disability during activities of daily living and sport will be completed. The questionnaires will include the Ankle Instability Instrument, the Foot and Ankle Ability Measure, and the Foot and Ankle Ability Measure-Sport.

  • Self-assessed disability [ Time Frame: Change from baseline disability at 1-week post intervention ] [ Designated as safety issue: No ]
    3 questionnaires regarding self-assessed disability during activities of daily living and sport will be completed. The questionnaires will include the Ankle Instability Instrument, the Foot and Ankle Ability Measure, and the Foot and Ankle Ability Measure-Sport.

  • Self-assessed disability [ Time Frame: Change from baseline disability at 1-month post intervention ] [ Designated as safety issue: No ]
    3 questionnaires regarding self-assessed disability during activities of daily living and sport will be completed. The questionnaires will include the Ankle Instability Instrument, the Foot and Ankle Ability Measure, and the Foot and Ankle Ability Measure-Sport.


Other Outcome Measures:
  • Confidence in Math Ability [ Time Frame: At the baseline test session ] [ Designated as safety issue: No ]
  • Ability to count backwards by 7s [ Time Frame: At the baseline test session ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Balance Training Behavioral: Balance Training
This is a 4-week supervised balance training program that has been previously validated in those with CAI by improving subjective and objective measures of function. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. The specific exercises and repetitions that will be performed per training session will include: 1) hop to stabilization (10 repetitions per direction), 2) hop to stabilization and reach (5 repetitions per direction), 3) unanticipated hop to stabilization (3 repetitions), 4) progressive single limb stance balance activities (3 repetitions), and 5) progressive single limb stance activities with eyes closed (3 repetitions).
Experimental: Balance Training w/ STARS Behavioral: Balance Training
This is a 4-week supervised balance training program that has been previously validated in those with CAI by improving subjective and objective measures of function. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. The specific exercises and repetitions that will be performed per training session will include: 1) hop to stabilization (10 repetitions per direction), 2) hop to stabilization and reach (5 repetitions per direction), 3) unanticipated hop to stabilization (3 repetitions), 4) progressive single limb stance balance activities (3 repetitions), and 5) progressive single limb stance activities with eyes closed (3 repetitions).
Behavioral: STARS
The STARS intervention will consist of 4 unique sensory-targeted interventions: calf stretching, ankle joint traction, anterior/posterior ankle joint mobilizations, and plantar massage. These four techniques target 3 types of sensory pathways (musculotendinous, articular, and plantar cutaneous, respectively) and will be applied in the same order for all treatment sessions: 1) 60-second calf stretch, 2) 30-second ankle traction, 3) 30-second mobilization, 4) 2-minute plantar massage, 5) 30-second ankle traction, and 6) 30-second mobilization.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01790581

Contacts
Contact: Erik A Wikstrom, PhD 704-687-0871 ewikstrom@uncc.edu

Locations
United States, North Carolina
University of North Carolina at Charlotte Recruiting
Charlotte, North Carolina, United States, 28223
Contact: Erik A Wikstrom, PhD    704-687-0871    ewikstrom@uncc.edu   
Principal Investigator: Erik A Wikstrom, PhD         
Sponsors and Collaborators
University of North Carolina, Charlotte
Mid-Atlantic Athletic Trainers' Association
Investigators
Principal Investigator: Erik A Wikstrom, PhD University of North Carolina at Charlotte
  More Information

Additional Information:
Publications:
Responsible Party: Erik Wikstrom, PhD, ATC, Assistant Professor, University of North Carolina, Charlotte
ClinicalTrials.gov Identifier: NCT01790581     History of Changes
Other Study ID Numbers: UNCC12-09-16
Study First Received: February 8, 2013
Last Updated: May 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Charlotte:
Chronic Ankle Instability

ClinicalTrials.gov processed this record on October 16, 2014