NCT04139044

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 18, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 25, 2019

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2019

Completed
Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

9 months

First QC Date

October 23, 2019

Last Update Submit

October 20, 2020

Conditions

Keywords

ankle, joint instability, cross-education, rehabilitation

Outcome Measures

Primary Outcomes (6)

  • 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

  • Balance Error Scoring System

    The BESS is a valid test to find out deficits in static postural control of individuals with CAI.

    4 weeks

  • 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

  • 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

  • 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

  • Side Hop Test

    Side Hop test is a test used to evaluate the explosive power of the lower extremity of athletes.

    4 weeks

Secondary Outcomes (1)

  • Cumberland Ankle Instability Tool

    Baseline

Study Arms (3)

Stable Ankle Training Group (SG)

EXPERIMENTAL

Balance Exercise Training for Only The Stable Ankle

Procedure: Balance Exercise Training for Stable Ankle

Unstable Ankle Training Group (UG)

EXPERIMENTAL

Balance Exercise Training for Only The Unstable Ankle

Procedure: Balance Exercise Training for Unstable Ankle

Control Group (CG)

NO INTERVENTION

No balance exercise training

Interventions

Balance and hop stabilization exercises were administered for 30 minutes of each exercise session.

Stable Ankle Training Group (SG)

Balance and hop stabilization exercises were administered for 30 minutes of each exercise session.

Unstable Ankle Training Group (UG)

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yeditepe University

Istanbul, Ataşehir, 34755, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Ankle InjuriesJoint Instability

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and InjuriesJoint DiseasesMusculoskeletal Diseases

Study Officials

  • Ayça Yağcıoğlu, MSc

    Yeditepe University, Health Sciences Faculty, Physiotherapy and Rehabilitation

    PRINCIPAL INVESTIGATOR
  • Gökhan Metin, Professor

    Istanbul University, Faculty of Medicine, Sports Medicine

    STUDY CHAIR
  • Feryal Subaşı, Professor

    Yeditepe University, Health Sciences Faculty, Physiotherapy and Rehabilitation

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2019

First Posted

October 25, 2019

Study Start

February 18, 2019

Primary Completion

November 14, 2019

Study Completion

December 18, 2019

Last Updated

October 22, 2020

Record last verified: 2020-10

Locations