Parkinson DiseaseNCT03413787
The Türkish Version of the Freezing of Gait Questionnaire
An observational study of Parkinson Disease and Motor Disorder, run by Ordu University at 1 site in Turkey (Türkiye).
Trial summary
The freezing of gait (FOG) is one of the disabling symptoms in Parkinson's disease. The diagnosis and assessment of the FOG may be diffucult, but it is absolutely necessary. The aim of this study was to develop a Türkish version of the freezing of gait questionnaire (FOG-Q) and assess the validity and reliability of… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease, Motor Disorder, Gait Disorders, Neurologic
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Jan 2018to 19 Feb 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will be selected from neurologic clinic.
Who may be able to join
- a clinical diagnosis of idiopathic PD
- able to walk with or without a walking device
Who cannot join
- a diagnosis of other neurological disorders
- any other medical conditions
- not able to take commands.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Türkish Version of the Freezing of Gait Questionnaire in Patients With Parkinson's Disease
The freezing of gait (FOG) is one of the disabling symptoms in Parkinson's disease. The diagnosis and assessment of the FOG may be diffucult, but it is absolutely necessary. The aim of this study was to develop a Türkish version of the freezing of gait questionnaire (FOG-Q) and assess the validity and reliability of this Türkish version.
The researchers firstly communicated with the developers of the FOG-Q. The permission for Turkish version was received by Giladi. Then, the FOG-Q will be adapted into Türkish using forward-backward translation by three native Türkish-speaking forward translators and one native English-speaking backward translator. The internal reliability of the FOG-Q 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 FOG-Q scores and scores of the UPDRS motor section , Berg Balance Scale, Timed up and go test, Falls Efficacy Scale and Hoehn and Yahr stages.
- Medical subject headings
- Parkinson Disease, Motor Disorders, Gait Disorders, Neurologic
What is being measured
The primary outcome is the main question the study is designed to answer.
Türkish version of the Freezing of Gait Questionnaire
Türkish version of the Freezing of Gait Questionnaire determine the episode of the freezing and the severity of the freezing by six items. Each items with five response categories (scored from 0 to 4) that are summed into a total score (range 0-24; higher scores = more severe FOG).
Measured: 5 minutes
Secondary outcomes (5)
Unified Parkinson's Disease Rating Scale-part III
Türkish version of the Unified Parkinson's Disease Rating Scale (UPDRS) will be used. UPDRS-part III evaluate the motor symptoms observational by neurologist. (UPDRS) scored from 0 (normal) to 4 (maximum disability); the total score change between 0 and 56. High scores mean worse motor function.
Measured: 5 minutes
Berg Balance Scale
The balance will be evaluated observational during 14 different balance activities. Each item will be scored between 1 and 4. The test score change between 0 and 56. The high score indicates better balance ability.
Measured: 10 minutes
Timed up and go test
This test will be used to measure the progress of balance, sit to stand, and walking. The participants stands up upon therapist's command walks 3 meters, turns around, walks back to the chair and sits down.
The time stops when the patient is seated. Time will be recorded.
Measured: 2 minutes
Fall Efficacy Scale
7 item-Fall Efficacy Scale (FES) will be used. FES is a questionnaire that assesses fear of falling. The score of the scale change 0-100 and the score above 70 indicates the fear of falling.
Measured: 5 minutes
Hoehn and Yahr Scale
The Hoehn and Yahr Scale (HYS) will be used to assess the severity in Parkinson's Disease based on clinical findings and functional disability. In HYS is a rating scale measured in an ordinal level. Here higher rates describe an increase severity of the disease.
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 posted29 Jan 2018
- Study start29 Jan 2018
- Primary completion12 Feb 2018
- Study completion19 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 50 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 ACARÖZ CANDAN, PhD, Principal investigator, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03413787
- Sponsor's protocol ID
- Ordu2
- Status last verified
- Mar 2018
- First submitted
- 22 Jan 2018
- Last updated
- 23 Mar 2018
- 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 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Türkish Version of the Freezing of Gait Questionnaire in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03413787
- Acronym / sponsor ID
- Ordu2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 29 Jan 2018 (actual)
- Primary completion
- 12 Feb 2018 (actual)
- Study completion
- 19 Feb 2018 (actual)
- First posted
- 29 Jan 2018 (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.
The freezing of gait (FOG) is one of the disabling symptoms in Parkinson's disease. The diagnosis and assessment of the FOG may be diffucult, but it is absolutely necessary. The aim of this study was to develop a Türkish version of the freezing of gait questionnaire (FOG-Q) and assess the validity and reliability of this Türkish version.
The researchers firstly communicated with the developers of the FOG-Q. The permission for Turkish version was received by Giladi. Then, the FOG-Q will be adapted into Türkish using forward-backward translation by three native Türkish-speaking forward translators and one native English-speaking backward translator. The internal reliability of the FOG-Q 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 FOG-Q scores and scores of the UPDRS motor section , Berg Balance Scale, Timed up and go test, Falls Efficacy Scale and Hoehn and Yahr stages.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will be selected from neurologic clinic.
Key inclusion criteria (2 listed)
- a clinical diagnosis of idiopathic PD
- able to walk with or without a walking device
Key exclusion criteria (3 listed)
- a diagnosis of other neurological disorders
- any other medical conditions
- not able to take commands.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Türkish version of the Freezing of Gait Questionnaire
Time frame: 5 minutes
Türkish version of the Freezing of Gait Questionnaire determine the episode of the freezing and the severity of the freezing by six items. Each items with five response categories (scored from 0 to 4) that are summed into a total score (range 0-24; higher scores = more severe FOG).
5 secondary outcomes
Unified Parkinson's Disease Rating Scale-part III
Time frame: 5 minutes
Berg Balance Scale
Time frame: 10 minutes
Timed up and go test
Time frame: 2 minutes
Fall Efficacy Scale
Time frame: 5 minutes
Hoehn and Yahr Scale
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 23 Mar 2018.
- 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 ACARÖZ 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 Parkinson Disease and Motor Disorder, 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 2 inclusion and 3 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 23 Mar 2018. 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?
Türkish version of the Freezing of Gait Questionnaire (time frame: 5 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 23 Mar 2018.