NCT04816058

Brief Summary

This study aimed to translate the Ankle Instability Instrument into Turkish language, to perform a cultural adaptation study and to evaluate its validity and reliability in the Turkish population. Ankle Instability Instrument was developed to determine the ankle instability level of individuals with a history of ankle injury. Assessment of ankle instability is particularly useful in determining the complaints and functional levels of individuals with a history of functional or chronic ankle instability. It is anticipated that introducing this scale to our language will contribute to other studies in this field.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Typical duration for all trials

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

First Submitted

Initial submission to the registry

March 23, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

March 25, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2023

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

2.3 years

First QC Date

March 23, 2021

Last Update Submit

August 11, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Ankle Instability Instrument

    The Ankle Instability Instrument includes 9 questions that can be answered with yes or no. The first version was developed with 21 questions and later modified into 9 questions. The Ankle Instability Instrument determines the development of functional ankle instability in individuals with an ankle injury. The International Ankle Consortium reported that answering yes to 5 of 9 questions will confirm the presence of functional ankle instability. There are French and Iran versions of the Ankle Instability Instrument.

    2 weeks

  • Cumberland Ankle Instability Tool

    The ankle instability levels of the participants included in the study will be determined by the Cumberland Ankle Instability Tool. The Cumberland Ankle Instability Tool is a self-assessment scale that determines the presence of functional or chronic ankle instability and the severity of the instability. This scale consists of 9 items and the total score varies between 0 and 30. Lower scores indicate more severe instability.

    1 day

Secondary Outcomes (1)

  • Short Form 12

    1 day

Study Arms (2)

Ankle Instability Group

Patients with a history of ankle instability or injury.

Behavioral: Determining the level of ankle instability

Healthy Group

Participants without a history of ankle injury

Behavioral: Determining the level of ankle instability

Interventions

Ankle instability

Ankle Instability GroupHealthy Group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Participants with a history of ankle injury and healthy population.

You may qualify if:

  • History of ankle injury or sprain at least one time
  • Aged between 18 to 40 years

You may not qualify if:

  • Neurological or orthopedic disorders that may affect ankle instability.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acıbadem University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 23, 2021

First Posted

March 25, 2021

Study Start

March 25, 2021

Primary Completion

July 1, 2023

Study Completion

July 15, 2023

Last Updated

August 14, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations