FallNCT04019587
Turkish Version of Fear of Falling Avoidance Behavior Questionnaire
An observational study of Fall and Fear, run by Ordu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Fall, Fear, Older People
- What is being tested?
- Fear of Falling Avoidance Behavior Questionnaire administration
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2019to 31 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Community dwelling older adults
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cross-Cultural Adaptation and Psychometric Properties of the Fear of Falling Avoidance Behaviour in Turkish Community-dwelling Older Adults
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.
Read the detailed description
The permission for the Turkish version was received by Landers. The translation will be made according to Beaton et al. guidelines. The internal reliability of the FFABQ Türkish version will be assessed using Cronbach's alpha, and item analyses will be conducted by examining the effect on Cronbach's alpha of excluding each of the six FOG-Q items individually. The test-retest reliability will be assessed using intraclass correlation coefficient (ICC).
Convergent validity will be evaluated by means of Spearman rank correlation coefficient (rs). In this section will be determined the correlation between the Activities-specific Balance Confidence Scale and visual analog scale for fear of falling.
- Conditions
- Fall, Fear, Older People
- Being tested
- Fear of Falling Avoidance Behavior Questionnaire administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fear of Falling Avoidance Behavior Questionnaire administrationDiagnostic test
The Questionnaire includes 14 items dealing with avoidance behavior. All items will be asked by face to face technique.
| Study group | Role | What they receive |
|---|---|---|
| Test of reliability and validity | Not described Receives: Diagnostic Test: Fear of Falling Avoidance Behavior Questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 minutes
Secondary outcomes (2)
Activities-specific Balance Confidence (ABC)
The Activity-specific Balance Confidence (ABC) Scale is commonly recommended for evaluating the person's confidence related to fear of falling.The ABC scale contains 16 items to assess balance confidence in performing simple to complex activities, such as walking around the house, stepping onto an escalator, and walking outside on an icy sidewalk.6,22 The total score of ABC scale ranges from 0% - 100%, where 0% means "not confident" and 100% means "completely confident".22 The confidence scores could be interpreted in a categorical fashion of high (> 80%), moderate (50 - 80%) and low (< 50%) levels of physical functioning.
Measured: 10 minutes
Visual Analog Scale (VAS) for Fear of Balance
10 points VAS will be used to assess the fear of falling. The older adult scores their fear with the number that best expresses the fear of falling. 0 indicates no fear and 10 indicates extreme fear.
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start15 Jul 2019
- Primary completion30 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FallStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevim ACARÖZ CANDAN, Ordu University
- Investigators
- Sevim A CANDAN, PhD, Principal investigator, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04019587
- Sponsor's protocol ID
- OrduU5
- Status last verified
- Dec 2019
- First submitted
- 11 Jul 2019
- Last updated
- 3 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-Cultural Adaptation and Psychometric Properties of the Fear of Falling Avoidance Behaviour in Turkish Community-dwelling Older Adults
- ClinicalTrials.gov ID
- NCT04019587
- Acronym / sponsor ID
- OrduU5
- Conditions
- Fall, Fear, Older People
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 15 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The permission for the Turkish version was received by Landers. The translation will be made according to Beaton et al. guidelines. The internal reliability of the FFABQ Türkish version will be assessed using Cronbach's alpha, and item analyses will be conducted by examining the effect on Cronbach's alpha of excluding each of the six FOG-Q items individually. The test-retest reliability will be assessed using intraclass correlation coefficient (ICC).
Convergent validity will be evaluated by means of Spearman rank correlation coefficient (rs). In this section will be determined the correlation between the Activities-specific Balance Confidence Scale and visual analog scale for fear of falling.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test of reliability and validity | – | Diagnostic Test: Fear of Falling Avoidance Behavior Questionnaire administration |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Community dwelling older adults
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fear of Falling Avoidance Behavior Questionnaire administrationThe Questionnaire includes 14 items dealing with avoidance behavior. All items will be asked by face to face technique. | Diagnostic test | Test of reliability and validity |
Primary outcome
Fear of Falling Avoidance Behavior Questionnaire (FFABQ)
Time frame: 7 minutes
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.
2 secondary outcomes
Activities-specific Balance Confidence (ABC)
Time frame: 10 minutes
Visual Analog Scale (VAS) for Fear of Balance
Time frame: 2 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sevim A CANDAN, PhD principal investigator
Ordu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fall and Fear, run by Ordu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fear of Falling Avoidance Behavior Questionnaire (FFABQ) (time frame: 7 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2019.