- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03413787
The Türkish Version of the Freezing of Gait Questionnaire
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.
Study Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Altinordu
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Ordu, Altinordu, Turkey, 52100
- Sevim ACARÖZ CANDAN
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- a clinical diagnosis of idiopathic PD
- able to walk with or without a walking device
Exclusion Criteria:
- a diagnosis of other neurological disorders
- any other medical conditions
- not able to take commands.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Timed up and go test
Time Frame: 2 minutes
|
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. |
2 minutes
|
Unified Parkinson's Disease Rating Scale-part III
Time Frame: 5 minutes
|
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.
|
5 minutes
|
Berg Balance Scale
Time Frame: 10 minutes
|
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.
|
10 minutes
|
Fall Efficacy Scale
Time Frame: 5 minutes
|
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.
|
5 minutes
|
Hoehn and Yahr Scale
Time Frame: 2 minutes
|
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.
|
2 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sevim ACARÖZ CANDAN, PhD, T.C. ORDU ÜNİVERSİTESİ
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Neurologic Manifestations
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Disease
- Parkinson Disease
- Nervous System Diseases
- Gait Disorders, Neurologic
- Motor Disorders
Other Study ID Numbers
- Ordu2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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