NCT04064502

Brief Summary

The purpose of this study was to evaluate the prevalence of chronic ankle instability using the Cumberland Ankle Instability Tool (CAIT) and investigate the independent associated factors. The data was collected from adult volunteers by questionnaire including sociodemographic information, general medical condition, history of orthopedic surgery, pain intensity, and the number of painful areas of the foot.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
273

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2019

Completed
29 days until next milestone

First Posted

Study publicly available on registry

August 22, 2019

Completed
Last Updated

August 22, 2019

Status Verified

July 1, 2019

Enrollment Period

7 months

First QC Date

July 24, 2019

Last Update Submit

August 20, 2019

Conditions

Keywords

Chronic Ankle InstabilityCumberland Ankle Instability ToolPain

Outcome Measures

Primary Outcomes (1)

  • chronic ankle instability

    Cumberland Ankle Instability Tool (CAIT) is a 9-item questionnaire generating a score from 0 to 30 for each ankle, in which 0 is the worst possible score, meaning severe instability, and 30 is the best possible score, meaning stability. The CAIT is considered a reliable instrument to distinguish between stable and unstable ankles, meanwhile, measuring the severity of functional ankle instability.

    6 months

Study Arms (1)

volunteers

273 adult volunteers ranging from 18-78 years old

Diagnostic Test: CHRONIC ANKLE INSTABILITY AND ASSOCIATED FACTORS:

Interventions

Questionnaire including sociodemographic information, general medical condition, history of orthopedic surgery, pain intensity, and the number of painful areas of the foot.

volunteers

Eligibility Criteria

Age18 Years - 34 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The cross-sectional study group consisted of 273 adult volunteers, ranging from 18-78 years old, who were recruited via social media to maximize outreach and insure a diverse target group.

You may qualify if:

  • being volunteer
  • volunteers above 18 years old

You may not qualify if:

  • history of acute ankle sprain
  • acute ankle fracture
  • receiving/having received physiotherapy and rehabilitation programs for foot and ankle problems
  • within the last 6 months,history of foot, ankle, and/or knee surgery
  • neuromuscular disorders
  • disorders affecting balance
  • diabetes mellitus complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uğur Şaylı

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Uğur Şaylı, MD, Prof.

    Yeditepe University Hospital

    STUDY CHAIR
  • Şule Demirbaş, Asst.Prof.

    editepe University, Faculty of Health Sciences, Deparment of Physiotherapy and Rehabilitation

    STUDY CHAIR
  • Feryal Subaşı, PT, Prof.

    Yeditepe University, Faculty of Health Sciences, Deparment of Physiotherapy and Rehabilitation

    STUDY CHAIR
  • Ebru Akbuğa, MSc, PT

    Yeditepe University, Faculty of Health Sciences, Deparment of Physiotherapy and Rehabilitation

    PRINCIPAL INVESTIGATOR
  • Elif Tuğçe Çil, MSc, PT

    Yeditepe University, Faculty of Health Sciences, Deparment of Physiotherapy and Rehabilitation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2019

First Posted

August 22, 2019

Study Start

May 1, 2017

Primary Completion

December 1, 2017

Study Completion

September 1, 2018

Last Updated

August 22, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will share

Locations