NCT04019587

Brief Summary

This study is planned to translate the Fear of Falling Avoidance Behaviour Questionnaire (FFABQ) into Turkish and to assess the psychometric properties (validity, reliability, responsiveness, floor and ceiling effect) of this Turkish version.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2019

Shorter than P25 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

July 11, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 15, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

July 15, 2019

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

December 3, 2019

Status Verified

December 1, 2019

Enrollment Period

15 days

First QC Date

July 11, 2019

Last Update Submit

December 1, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Fear of Falling Avoidance Behavior Questionnaire (FFABQ)

    The FFABQ quantifies avoidance behavior (activity limitation and participation restriction) related to the fear of falling. It consists of 14 items ranked using the Likert-style, 5-point ordinal scale as described above, resulting in a total possible score of 56 points. A high score indicates greater activity limitation and participation restriction as a result of the fear of the falling.

    7 minutes

Secondary Outcomes (2)

  • Activities-specific Balance Confidence (ABC)

    10 minutes

  • Visual Analog Scale (VAS) for Fear of Balance

    2 minutes

Study Arms (1)

Test of reliability and validity

Diagnostic Test: Fear of Falling Avoidance Behavior Questionnaire administration

Interventions

The Questionnaire includes 14 items dealing with avoidance behavior. All items will be asked by face to face technique.

Test of reliability and validity

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Community dwelling older adults

You may qualify if:

  • having good cognitive functions (Standardized Mini Mental Test score of 24 and above)
  • To be able to live independently in the community,
  • to voluntarily participate

You may not qualify if:

  • The use of drugs that may affect balance
  • Polypharmacy status
  • Having serious musculoskeletal or neurological disorders,
  • Lower or upper limb amputation that may affect balance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sevim ACARÖZ CANDAN

Ordu, Altinordu, 52100, Turkey (Türkiye)

Location

Study Officials

  • Sevim A CANDAN, PhD

    Ordu University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Physiotherapy and Rehabilitation

Study Record Dates

First Submitted

July 11, 2019

First Posted

July 15, 2019

Study Start

July 15, 2019

Primary Completion

July 30, 2019

Study Completion

July 31, 2019

Last Updated

December 3, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations