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

Sponsor

Georgia State University (Other)

Overall Status

Completed

CT.gov ID

NCT03447652

Collaborator

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

Enrollment

Locations

Arms

12.5

Actual Duration (Months)

6.1

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

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.

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	N/A

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

Study Type:

Interventional

Actual Enrollment :

43 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

4 independent groups4 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 :

Aug 14, 2017

Actual Primary Completion Date :

Aug 13, 2018

Actual Study Completion Date :

Aug 30, 2018

Arms and Interventions

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

Primary Outcome Measures

Static Balance Assessments [4 weeks]
Static Balance Clinical Tests
Functional Balance Assessments [4 weeks]
Functional Balance Clinical Tests
Patient Self-reported Outcomes [4 to 12 weeks]
Subjective Patient Reported Outcome Questionnaires

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Holy Innocents' Episcopal School	Atlanta	Georgia	United States	30327
2	The Lovett School	Atlanta	Georgia	United States	30327
3	The Westminister Schools	Atlanta	Georgia	United States	30327
4	Woodward Academy	College Park	Georgia	United States	30337
5	Decatur High School	Decatur	Georgia	United States	30030
6	The Walker School	Marietta	Georgia	United States	30062
7	Walton High School	Marietta	Georgia	United States	30062

Sponsors and Collaborators

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

Investigators

Study Director: Benjamin M Goerger, PhD, Georgia State University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Mary Spencer Cain, Doctoral Candidate, Georgia State University

ClinicalTrials.gov Identifier:

NCT03447652

Other Study ID Numbers:

CON006264

First Posted:

Feb 27, 2018

Last Update Posted:

Oct 15, 2018

Last Verified:

Oct 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Ankle Injuries

Study Results

No Results Posted as of Oct 15, 2018