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The Effects of Unilateral Balance Training Among Athletes With Chronic Ankle Instability

Primary Purpose

Ankle Injuries, Ankle Sprains

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Balance Exercise Training for Stable Ankle
Balance Exercise Training for Unstable Ankle
Sponsored by
Yeditepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Injuries focused on measuring ankle, joint instability, cross-education, rehabilitation

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Participating in the study on a voluntary basis
  • Athletes with 18-25 years old
  • Being a player in one of the basketball, volleyball, and handball team sports
  • Athletes with a history of at least 2 significant lateral ankle sprains which were classified as a second degree and related to inflammatory symptoms (pain, swelling)
  • The self-reported sensation of giving away and instability at the injured ankle confirmed by the Cumberland Ankle Instability Tool with a score ≤25
  • Recurrent lateral ankle sprain episodes of the injured ankle occurred at least 12 months
  • The self-reported function of the injured ankle confirmed by Foot and Ankle Ability Measure with a score <90% from activities of daily living subscale and <80% from sport subscale.

Exclusion Criteria:

  • A history of surgery to the musculoskeletal structures in either lower extremity
  • A history of a fracture in either lower extremity necessitating realignment
  • Acute injury of musculoskeletal structures of other joints of the lower extremity in the previous 3 months affecting joint function and integrity
  • Presence of bilateral ankle instability
  • Balance or vestibular disorder

Sites / Locations

  • Yeditepe University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Stable Ankle Training Group (SG)

Unstable Ankle Training Group (UG)

Control Group (CG)

Arm Description

Balance Exercise Training for Only The Stable Ankle

Balance Exercise Training for Only The Unstable Ankle

No balance exercise training

Outcomes

Primary Outcome Measures

Foot and Ankle Ability Measure
The FAAM is a self-reported tool improved to evaluate the physical functions of individuals with musculoskeletal disorders related to foot and ankle.
Balance Error Scoring System
The BESS is a valid test to find out deficits in static postural control of individuals with CAI.
Y Balance Test
The Y Balance Test is the functional test that is able to find out impairments in dynamic postural control among individuals with CAI
Single-Leg Countermovement Jump Test
The Single-LegCountermovement jump test is used to evaluate the lower-extremity power of athletes, and indirectly the functional performance.
Figure-of-Eight Hop Test
Figure-of-8 Hop Test is used to measure the explosive power of the lower extremity of athletes.
Side Hop Test
Side Hop test is a test used to evaluate the explosive power of the lower extremity of athletes.

Secondary Outcome Measures

Cumberland Ankle Instability Tool
Cumberland Ankle Instability Tool including a 30-point scale of 9-items is a valid and reliable questionnaire for distinguishing and quantifying the severity of functional instability.

Full Information

First Posted
October 23, 2019
Last Updated
October 20, 2020
Sponsor
Yeditepe University
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1. Study Identification

Unique Protocol Identification Number
NCT04139044
Brief Title
The Effects of Unilateral Balance Training Among Athletes With Chronic Ankle Instability
Official Title
The Effects of Unilateral Balance Training on Bilateral Balance and Explosive Power Among Athletes With Chronic Ankle Instability
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
February 18, 2019 (Actual)
Primary Completion Date
November 14, 2019 (Actual)
Study Completion Date
December 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yeditepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the study is to investigate the effects of a 4-week, unilateral balance exercise training program on bilateral balance and explosive power in athletes with chronic ankle instability. The participants were randomly divided into Stable Ankle Training Group (SG) (n=9), Unstable Ankle Training Group (UG) (n=9) and control group (CG) (n=10). The balance exercise training program was administered for only the stable ankle of athletes in SG and only the unstable ankle of athletes in UG, twice a week and for a 4-week duration.
Detailed Description
The aim of the study is to investigate the effects of a 4-week, unilateral balance exercise training program on bilateral balance and explosive power in athletes with chronic ankle instability (CAI). The study included 28 volunteer athletes with a history of CAI who registered as a team player at Yeditepe University Culture and Sports Directorate February 2019 - June 2019. The severity of functional ankle instability of all the athletes was assessed by the Cumberland Ankle Instability Tool (CAIT). Functional limitations of the athletes with CAI were evaluated by Foot and Ankle Ability Measure Activity of Daily Living Subscale (FAAM-ADL) and Sports Subscale (FAAM-S). Balance Error Scoring System (BESS) was used to determine the static balance performance of athletes. Dynamic balance was evaluated by the Y Balance Test (YBT). Sport performance including vertical jumping and hopping was assessed with Single-Legged Countermovement Jump (CMJ) Test, Figure-of-Eight Hop Test, and Side Hop Test. The athletes were randomly divided into Rehabilitation for the Stable Ankle Group (SG) (n=9), Rehabilitation for the Unstable Ankle Group (UG) (n=9) and Control Group (CG) (n=10). Athletes in SG and UG were included balance exercise training program. The balance exercise training program was administered for only the stable ankle of athletes in SG and only the unstable ankle of athletes in UG, twice a week and for a 4-week duration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Injuries, Ankle Sprains
Keywords
ankle, joint instability, cross-education, rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The sample of the study consists of athletes with a history of CAI who registered as a team player at Yeditepe University Culture and Sports Directorate between February 2019 and June 2019.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stable Ankle Training Group (SG)
Arm Type
Experimental
Arm Description
Balance Exercise Training for Only The Stable Ankle
Arm Title
Unstable Ankle Training Group (UG)
Arm Type
Experimental
Arm Description
Balance Exercise Training for Only The Unstable Ankle
Arm Title
Control Group (CG)
Arm Type
No Intervention
Arm Description
No balance exercise training
Intervention Type
Procedure
Intervention Name(s)
Balance Exercise Training for Stable Ankle
Intervention Description
Balance and hop stabilization exercises were administered for 30 minutes of each exercise session.
Intervention Type
Procedure
Intervention Name(s)
Balance Exercise Training for Unstable Ankle
Intervention Description
Balance and hop stabilization exercises were administered for 30 minutes of each exercise session.
Primary Outcome Measure Information:
Title
Foot and Ankle Ability Measure
Description
The FAAM is a self-reported tool improved to evaluate the physical functions of individuals with musculoskeletal disorders related to foot and ankle.
Time Frame
4 weeks
Title
Balance Error Scoring System
Description
The BESS is a valid test to find out deficits in static postural control of individuals with CAI.
Time Frame
4 weeks
Title
Y Balance Test
Description
The Y Balance Test is the functional test that is able to find out impairments in dynamic postural control among individuals with CAI
Time Frame
4 weeks
Title
Single-Leg Countermovement Jump Test
Description
The Single-LegCountermovement jump test is used to evaluate the lower-extremity power of athletes, and indirectly the functional performance.
Time Frame
4 weeks
Title
Figure-of-Eight Hop Test
Description
Figure-of-8 Hop Test is used to measure the explosive power of the lower extremity of athletes.
Time Frame
4 weeks
Title
Side Hop Test
Description
Side Hop test is a test used to evaluate the explosive power of the lower extremity of athletes.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Cumberland Ankle Instability Tool
Description
Cumberland Ankle Instability Tool including a 30-point scale of 9-items is a valid and reliable questionnaire for distinguishing and quantifying the severity of functional instability.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participating in the study on a voluntary basis Athletes with 18-25 years old Being a player in one of the basketball, volleyball, and handball team sports Athletes with a history of at least 2 significant lateral ankle sprains which were classified as a second degree and related to inflammatory symptoms (pain, swelling) The self-reported sensation of giving away and instability at the injured ankle confirmed by the Cumberland Ankle Instability Tool with a score ≤25 Recurrent lateral ankle sprain episodes of the injured ankle occurred at least 12 months The self-reported function of the injured ankle confirmed by Foot and Ankle Ability Measure with a score <90% from activities of daily living subscale and <80% from sport subscale. Exclusion Criteria: A history of surgery to the musculoskeletal structures in either lower extremity A history of a fracture in either lower extremity necessitating realignment Acute injury of musculoskeletal structures of other joints of the lower extremity in the previous 3 months affecting joint function and integrity Presence of bilateral ankle instability Balance or vestibular disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayça Yağcıoğlu, MSc
Organizational Affiliation
Yeditepe University, Health Sciences Faculty, Physiotherapy and Rehabilitation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gökhan Metin, Professor
Organizational Affiliation
Istanbul University, Faculty of Medicine, Sports Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Feryal Subaşı, Professor
Organizational Affiliation
Yeditepe University, Health Sciences Faculty, Physiotherapy and Rehabilitation
Official's Role
Study Chair
Facility Information:
Facility Name
Yeditepe University
City
Istanbul
State/Province
Ataşehir
ZIP/Postal Code
34755
Country
Turkey

12. IPD Sharing Statement

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The Effects of Unilateral Balance Training Among Athletes With Chronic Ankle Instability

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