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

NCT03447652 | Completed

• 1 other identifier: CON006264
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Chronic Ankle Instability; Ankle Sprains; Ankle Rehabilitation

Outcome Measures

Primary Outcomes (3)

• Static Balance Assessments

  Static Balance Clinical Tests

  4 weeks

• Functional Balance Assessments

  Functional Balance Clinical Tests

  4 weeks

• Patient Self-reported Outcomes

  Subjective Patient Reported Outcome Questionnaires

  4 to 12 weeks

Study Arms (4)

Control Group

NO INTERVENTION

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.

Resistance Band Group

EXPERIMENTAL

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

Biomechanical Ankle Platform System

EXPERIMENTAL

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

Combination Group

EXPERIMENTAL

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

Interventions

Resistance Band Ankle Rehabilitation OTHER

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

Resistance Band Group

Biomechanical Ankle Platform System Rehabilitation OTHER

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

Biomechanical Ankle Platform System

Combination Rehabilitation OTHER

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

Combination Group

Eligibility Criteria

• Age: 15 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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".

You may not qualify if:

• 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.

Sponsors & Collaborators

• Georgia State University: lead
• National Athletic Trainers' Association Research & Education Foundation (NATA Foundation): collaborator

Study Sites (7)

Holy Innocents' Episcopal School

Atlanta, Georgia, 30327, United States

Location

The Lovett School

Atlanta, Georgia, 30327, United States

Location

The Westminister Schools

Atlanta, Georgia, 30327, United States

Location

Woodward Academy

College Park, Georgia, 30337, United States

Location

Decatur High School

Decatur, Georgia, 30030, United States

Location

The Walker School

Marietta, Georgia, 30062, United States

Location

Walton High School

Marietta, Georgia, 30062, United States

Location

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  PMID: 32577737 DERIVED

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Officials

• Benjamin M Goerger, PhD

  Georgia State University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor is blinded to which group the subjects were in.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Candidate

Model Details: 4 independent groups

Study Record Dates

• First Submitted: January 28, 2018
• First Posted: February 27, 2018
• Study Start: August 14, 2017
• Primary Completion: August 13, 2018
• Study Completion: August 30, 2018
• Last Updated: October 15, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)