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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04139044
Other study ID # YeditepeUptr
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 18, 2019
Est. completion date December 18, 2019

Study information

Verified date October 2020
Source Yeditepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date December 18, 2019
Est. primary completion date November 14, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 25 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Balance Exercise Training for Stable Ankle
Balance and hop stabilization exercises were administered for 30 minutes of each exercise session.
Balance Exercise Training for Unstable Ankle
Balance and hop stabilization exercises were administered for 30 minutes of each exercise session.

Locations

Country Name City State
Turkey Yeditepe University Istanbul Atasehir

Sponsors (1)

Lead Sponsor Collaborator
Yeditepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 4 weeks
Primary Balance Error Scoring System The BESS is a valid test to find out deficits in static postural control of individuals with CAI. 4 weeks
Primary 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 4 weeks
Primary 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. 4 weeks
Primary Figure-of-Eight Hop Test Figure-of-8 Hop Test is used to measure the explosive power of the lower extremity of athletes. 4 weeks
Primary Side Hop Test Side Hop test is a test used to evaluate the explosive power of the lower extremity of athletes. 4 weeks
Secondary 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. Baseline
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