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

Primary Purpose

Chronic Ankle Instability, Ankle Sprains, Ankle Rehabilitation

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Resistance Band Ankle Rehabilitation

Biomechanical Ankle Platform System Rehabilitation

Combination Rehabilitation

About this trial

This is an interventional prevention trial for Chronic Ankle Instability

Eligibility Criteria

15 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Holy Innocents' Episcopal School
The Lovett School
The Westminister Schools
Woodward Academy
Decatur High School
The Walker School
Walton High School

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Resistance Band Group

Biomechanical Ankle Platform System

Combination Group

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Static Balance Assessments

Static Balance Clinical Tests

Functional Balance Assessments

Functional Balance Clinical Tests

Patient Self-reported Outcomes

Subjective Patient Reported Outcome Questionnaires

Secondary Outcome Measures

Full Information

NCT ID

NCT03447652

First Posted

January 28, 2018

Last Updated

October 12, 2018

Sponsor

Georgia State University

Collaborators

National Athletic Trainers' Association Research & Education Foundation (NATA Foundation)

1. Study Identification

Unique Protocol Identification Number

NCT03447652

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

August 14, 2017 (Actual)

Primary Completion Date

August 13, 2018 (Actual)

Study Completion Date

August 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Georgia State University

Collaborators

National Athletic Trainers' Association Research & Education Foundation (NATA Foundation)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Ankle Instability, Ankle Sprains, Ankle Rehabilitation

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

4 independent groups

Masking

Outcomes Assessor

Masking Description

Outcomes assessor is blinded to which group the subjects were in.

Allocation

Randomized

Enrollment

43 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

Arm Title

Resistance Band Group

Arm Type

Experimental

Arm Description

Arm Title

Biomechanical Ankle Platform System

Arm Type

Experimental

Arm Description

Arm Title

Combination Group

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Resistance Band Ankle Rehabilitation

Intervention Description

Resistance Band - uses a tension band to provide resistance during ankle motion

Intervention Type

Other

Intervention Name(s)

Biomechanical Ankle Platform System Rehabilitation

Intervention Description

Biomechanical Ankle Platform System Board Group - uses different levels of half spheres to increase the amount of motion allowed at the ankle.

Intervention Type

Other

Intervention Name(s)

Combination Rehabilitation

Intervention Description

Combination Group - includes both the resistance band and Biomechanical Ankle Platform System programs.

Primary Outcome Measure Information:

Title

Static Balance Assessments

Description

Static Balance Clinical Tests

Time Frame

4 weeks

Title

Functional Balance Assessments

Description

Functional Balance Clinical Tests

Time Frame

4 weeks

Title

Patient Self-reported Outcomes

Description

Subjective Patient Reported Outcome Questionnaires

Time Frame

4 to 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Benjamin M Goerger, PhD

Organizational Affiliation

Georgia State University

Official's Role

Study Director

Facility Information:

Facility Name

Holy Innocents' Episcopal School

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30327

Country

United States

Facility Name

The Lovett School

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30327

Country

United States

Facility Name

The Westminister Schools

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30327

Country

United States

Facility Name

Woodward Academy

City

College Park

State/Province

Georgia

ZIP/Postal Code

30337

Country

United States

Facility Name

Decatur High School

City

Decatur

State/Province

Georgia

ZIP/Postal Code

30030

Country

United States

Facility Name

The Walker School

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30062

Country

United States

Facility Name

Walton High School

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30062

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

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

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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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