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A Study Investigating The Effects Of An Ankle Rehabilitation Program On High School Athletes With Ankle Instability

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ClinicalTrials.gov Identifier: NCT03447652
Recruitment Status : Completed
First Posted : February 27, 2018
Last Update Posted : October 15, 2018
Sponsor:
Collaborator:
National Athletic Trainers' Association Research & Education Foundation (NATA Foundation)
Information provided by (Responsible Party):
Mary Spencer Cain, Georgia State University

Study Description
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Brief Summary:
A randomized controlled trial investigating the effects of a 4-week ankle rehabilitation program on high school athletes with chronic ankle instability.

Condition or disease Intervention/treatment Phase
Chronic Ankle Instability Ankle Sprains Ankle Rehabilitation Other: Resistance Band Ankle Rehabilitation Other: Biomechanical Ankle Platform System Rehabilitation Other: Combination Rehabilitation Not Applicable

Detailed Description:
A randomized controlled trial investigating the effects of a three different 4-week ankle rehabilitation programs on high school athletes with chronic ankle instability. We will use questionnaires to assess subjective level of function and clinical measures to assess clinical functionality via static and functional balance.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 4 independent groups
Masking: Single (Outcomes Assessor)
Masking Description: Outcomes assessor is blinded to which group the subjects were in.
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial Investigating The Effects Of A 4-Week Ankle Rehabilitation Program On High School Athletes With Chronic Ankle Instability
Actual Study Start Date : August 14, 2017
Actual Primary Completion Date : August 13, 2018
Actual Study Completion Date : August 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control Group
Each patient in the control group did not perform any rehabilitation exercises. Over the intervention time frame, the patient was required to check in with a member of the research team each week to discuss any changes in their ankle or report any injury incidence.
Experimental: Resistance Band Group
Each session, patients completed resistance training using a resistance band in 4 directions of ankle motion (plantarflexion, dorsiflexion, inversion and eversion). Patients would complete 3 sets of 10 repetitions during each session. Every 3 sessions, the band resistance would increase.
 Other: Resistance Band Ankle Rehabilitation
Resistance Band - uses a tension band to provide resistance during ankle motion
Experimental: Biomechanical Ankle Platform System
The Biomechanical Ankle Platform System board is an oval shaped board that utilizes a half-sphere on the bottom of the board to allow the patient to train on an unstable surface. A one legged stance on their involved limb was performed on the Biomechanical Ankle Platform System board while clockwise and counterclockwise circles were completed. The initial rotation of direction was selected by the patient and changed every 10 seconds of the 40-second trial. Five 40-second trials were completed with 1-minute rest intervals in between the trials. Progression was determined by the supervising clinician and was based on the patient's ability to make smooth transitions between direction changes and completion of smooth circular rotations in both directions.
 Other: Biomechanical Ankle Platform System Rehabilitation
Biomechanical Ankle Platform System Board Group - uses different levels of half spheres to increase the amount of motion allowed at the ankle.
Experimental: Combination Group
Patients completing the combination protocol completed both the resistance band and Biomechanical Ankle Platform System board protocols during each session. The order of exercise completion was counterbalanced for each session.
 Other: Combination Rehabilitation
Combination Group - includes both the resistance band and Biomechanical Ankle Platform System programs.


Outcome Measures
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Primary Outcome Measures :
  1. Static Balance Assessments [ Time Frame: 4 weeks ]
    Static Balance Clinical Tests

  2. Functional Balance Assessments [ Time Frame: 4 weeks ]
    Functional Balance Clinical Tests

  3. Patient Self-reported Outcomes [ Time Frame: 4 to 12 weeks ]
    Subjective Patient Reported Outcome Questionnaires


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • active for at least 1.5 hours a week, a history of at least 1 significant ankle sprain that required medical intervention, repeated symptoms of pain, swelling, weakness, instability, and repeated episodes of "giving way".

Exclusion Criteria:

  • presence of any current lower extremity injury (diagnosed by a medical professional within last 3 months with present symptoms), previous surgery to either leg, diagnosed ankle sprain within the past 6 weeks, history of ankle fractures and/or dislocations.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03447652


Locations
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United States, Georgia
Holy Innocents' Episcopal School
Atlanta, Georgia, United States, 30327
The Lovett School
Atlanta, Georgia, United States, 30327
The Westminister Schools
Atlanta, Georgia, United States, 30327
Woodward Academy
College Park, Georgia, United States, 30337
Decatur High School
Decatur, Georgia, United States, 30030
The Walker School
Marietta, Georgia, United States, 30062
Walton High School
Marietta, Georgia, United States, 30062
Sponsors and Collaborators
Georgia State University
National Athletic Trainers' Association Research & Education Foundation (NATA Foundation)
Investigators
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Study Director: Benjamin M Goerger, PhD Georgia State University
More Information
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Publications:
Global Health Risks: Mortality and Burden of Disease Attributable to Selected Major RIsks. Geneva: World Health Organization; 2012
Clark VM, Burden AM. A 4-week wobble board exercise programme imploved muscle onset latency and perceived stability in individuals with a functionally unstable ankle. Phys Ther Sport. 2005;6(4):181-187
Dinesha A, Prasad B A. Effect of 2-week and 4-week wobble board exercise programme for improving the muscle onset latency and perceived stability in basketball players with recurrent ankle sprain. Indian J Physiother Occup Ther. 2011;5(1):27-32.
Kennedy JG, Hodgkins CW, Sculco P, Carter T, Robinson SP. Sports Injuries of The Foot and Ankle in The Adolescent Athlete. Int Sports Med J. 2006;7(2):85-97
Martin RL, Burdett RG. Development of the Foot and Ankle Disability Index (FADI) [Abstract]. J Orthop Sports Phys Ther. 1999;29:A32-A33
Donahue M, Simon J, Docherty C. Reliability and Validity of a New Questionnaire Created to Establish the Presence of Functional Ankle Instability: The IdFAI. Athl Train Sports Health Care. 2013;5(1):38-43.
Riemann BL, Guskiewicz KM, Shields EW. Relationship Between Clinical and Forceplate Measures of Postural Stability. J Sport Rehabil. 1999;8(2):71-82.
Dobo B, White A, Linens S. Balance Error Scoring System Stances That Identify Division I Athletes With Chronic Ankle Instability Most in Need of Rehabilitation. Athl Train Sports Health Care. 2015;7(5):190-196
Chrintz H, Falster O, Roed J. Single-leg Postural Equilibrium Test. Scand J Med Sci Sports. 1991;1(4):244-246
Munn J, Beard DJ, Refshauge KM, Lee RW. Do Functional-Performance Tests Detect Impairment in Subjects With Ankle Instability. J Sport Rehabil. 2002;11(1):40-50.
Gribble PA, Hertel J. Considerations for normalizing measures of the star excursion balance test. Meas Phys Educ Exerc Sci. 2003;7(2):89-100.
Hertel J, Miller SJ, Denegar CR. Intratester and intertester reliability during the star excursion balance tests. J Sports Rehabil. 2000;9(2):104-116.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mary Spencer Cain, Doctoral Candidate, Georgia State University
ClinicalTrials.gov Identifier: NCT03447652    
Other Study ID Numbers: CON006264
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual participant data is planned to be shared with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ankle Injuries
Leg Injuries
Wounds and Injuries