- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04139044
The Effects of Unilateral Balance Training Among Athletes With Chronic Ankle Instability
October 20, 2020 updated by: Yeditepe University
The Effects of Unilateral Balance Training on Bilateral Balance and Explosive Power Among Athletes With Chronic Ankle Instability
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
28
Phase
- 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
-
-
Ataşehir
-
Istanbul, Ataşehir, Turkey, 34755
- Yeditepe University
-
-
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
Ages Eligible for Study
18 years to 25 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
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: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Stable Ankle Training Group (SG)
Balance Exercise Training for Only The Stable Ankle
|
Balance and hop stabilization exercises were administered for 30 minutes of each exercise session.
|
|
EXPERIMENTAL: Unstable Ankle Training Group (UG)
Balance Exercise Training for Only The Unstable Ankle
|
Balance and hop stabilization exercises were administered for 30 minutes of each exercise session.
|
|
NO_INTERVENTION: Control Group (CG)
No balance exercise training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Foot and Ankle Ability Measure
Time Frame: 4 weeks
|
The FAAM is a self-reported tool improved to evaluate the physical functions of individuals with musculoskeletal disorders related to foot and ankle.
|
4 weeks
|
|
Balance Error Scoring System
Time Frame: 4 weeks
|
The BESS is a valid test to find out deficits in static postural control of individuals with CAI.
|
4 weeks
|
|
Y Balance Test
Time Frame: 4 weeks
|
The Y Balance Test is the functional test that is able to find out impairments in dynamic postural control among individuals with CAI
|
4 weeks
|
|
Single-Leg Countermovement Jump Test
Time Frame: 4 weeks
|
The Single-LegCountermovement jump test is used to evaluate the lower-extremity power of athletes, and indirectly the functional performance.
|
4 weeks
|
|
Figure-of-Eight Hop Test
Time Frame: 4 weeks
|
Figure-of-8 Hop Test is used to measure the explosive power of the lower extremity of athletes.
|
4 weeks
|
|
Side Hop Test
Time Frame: 4 weeks
|
Side Hop test is a test used to evaluate the explosive power of the lower extremity of athletes.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cumberland Ankle Instability Tool
Time Frame: Baseline
|
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.
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ayça Yağcıoğlu, MSc, Yeditepe University, Health Sciences Faculty, Physiotherapy and Rehabilitation
- Study Chair: Gökhan Metin, Professor, Istanbul University, Faculty of Medicine, Sports Medicine
- Study Chair: Feryal Subaşı, Professor, Yeditepe University, Health Sciences Faculty, Physiotherapy and Rehabilitation
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)
February 18, 2019
Primary Completion (ACTUAL)
November 14, 2019
Study Completion (ACTUAL)
December 18, 2019
Study Registration Dates
First Submitted
October 23, 2019
First Submitted That Met QC Criteria
October 23, 2019
First Posted (ACTUAL)
October 25, 2019
Study Record Updates
Last Update Posted (ACTUAL)
October 22, 2020
Last Update Submitted That Met QC Criteria
October 20, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YeditepeUptr
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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