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

October 12, 2018 updated by: Mary Spencer Cain, Georgia State University

A Randomized Controlled Trial Investigating The Effects Of A 4-Week Ankle Rehabilitation Program On High School Athletes With Chronic Ankle Instability

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
43

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30327
        • Holy Innocents' Episcopal School
      • Atlanta, Georgia, United States, 30327
        • The Lovett School
      • Atlanta, Georgia, United States, 30327
        • The Westminister Schools
      • College Park, Georgia, United States, 30337
        • Woodward Academy
      • Decatur, Georgia, United States, 30030
        • Decatur High School
      • Marietta, Georgia, United States, 30062
        • The Walker School
      • Marietta, Georgia, United States, 30062
        • Walton High School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Static Balance Assessments
Time Frame: 4 weeks
Static Balance Clinical Tests
4 weeks
Functional Balance Assessments
Time Frame: 4 weeks
Functional Balance Clinical Tests
4 weeks
Patient Self-reported Outcomes
Time Frame: 4 to 12 weeks
Subjective Patient Reported Outcome Questionnaires
4 to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Georgia State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Athletic Trainers' Association Research & Education Foundation (NATA Foundation)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Benjamin M Goerger, PhD, Georgia State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 14, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 13, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 28, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 15, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CON006264

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No individual participant data is planned to be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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