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Completed

NCT Number: NCT01790581

Balance Training vs. Balance Training w/ STARS

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.

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Key information

Conditions

Ankle (Ligaments); Instability (Old Injury)

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Charlotte

Charlotte, North Carolina, 28223, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Balance training

Behavioral

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).

STARS

Behavioral

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.

Primary outcomes

  1. 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).

  2. 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

  1. Balance

    Time frame: Change from baseline balance at 1-week 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).

  2. Self-assessed Disability

    Time frame: Change from baseline disability at 1-week 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.

  3. Self-assessed Disability

    Time frame: Change from baseline disability at 1-month post intervention

    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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Charlotte

Other

Collaborators

  • Mid-Atlantic Athletic Trainers' Association

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 13, 2013
Registry last updated
Jul 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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