NCT04789369

Brief Summary

Ankle sprain is frequently experienced by individuals participating in different sports activities. Ankle sprains have been shown to result in a decrease in level of physical activity and persistence of some symptoms for a long time. In this case, it is predicted that ankle sprains may affect the quality of life as well as functionality. Also, ankle sprain history may result in increased fear of movement, which may delay return to sports. This study aimed to examine the relationship between foot and ankle functionality, fear of movement and quality of life of elite athletes with a history of ankle sprain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

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 5, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 9, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

March 15, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2022

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2022

Completed
Last Updated

June 3, 2022

Status Verified

June 1, 2022

Enrollment Period

1.2 years

First QC Date

March 5, 2021

Last Update Submit

June 2, 2022

Conditions

Keywords

Quality of lifeFear of movementFunctionalityAnkle sprain

Outcome Measures

Primary Outcomes (3)

  • Foot and Ankle Ability Measure

    The Foot and Ankle Ability Measure will be used to determine the ankle functionality. This scale was developed to determine lower extremity functional level. It evaluates the level of difficulty of the person in activities in daily life in 21 items with a 5-point Likert-type scale, which means "4 = not difficult at all" and "0 = I cannot do it". At the same time, it can be reported within the scope of the scale that the specified activity cannot be implemented. High score means better functions.

    1 day

  • Short Form-12

    Short-Form 12 is a valid and reliable scale for determining the level of quality of life. This scale consists of 12 items and can be scored as 8 subscales which are physical function, restricted roles due to physical problems, pain, general health, energy / vitality, social functions, mental health and mental health with restricted roles due to emotional problems. All items are evaluated with a 5-point Likert-type scale, and higher scores indicate better quality of life.

    1 day

  • Fear Avoidance Beliefs Questionnaire

    The FABQ measures athletes' fear of pain and consequent avoidance of physical activity or sports because of their increased fear. The questionnaire contains 16 items between 0 and 6 while 0 indicates completely disagree and 6 indicates completely agree. The maximum score is 96 and higher scores indicates increased level of fear avoidance beliefs.

    1 day

Interventions

QuestionnairesBEHAVIORAL

Assessing the behavioral metrics (quality of life, functionality and fear of movement) with appropriate measurement tools

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Athletes who are participating in sportive activities regularly

You may qualify if:

  • No injury to the upper or lower extremities during data collection,
  • Being older than 18 years of age,
  • Individuals who volunteer to participate.

You may not qualify if:

  • Having had ankle surgery,
  • Has had an injury to his lower extremity in the last 3 months,
  • Individuals with a history of neurological / neuropsychiatric disease or arthritis will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sportomed Fulya Physiotherapy Center

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Ankle InjuriesKinesiophobia

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and InjuriesPhobic DisordersAnxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 5, 2021

First Posted

March 9, 2021

Study Start

March 15, 2021

Primary Completion

May 15, 2022

Study Completion

May 30, 2022

Last Updated

June 3, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations