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The Türkish Version of the Freezing of Gait Questionnaire

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03413787
Recruitment Status : Completed
First Posted : January 29, 2018
Last Update Posted : March 23, 2018
Sponsor:
Information provided by (Responsible Party):
Sevim ACARÖZ CANDAN, T.C. ORDU ÜNİVERSİTESİ

Brief 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 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.


Condition or disease
Parkinson Disease Motor Disorder Gait Disorders, Neurologic

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Türkish Version of the Freezing of Gait Questionnaire in Patients With Parkinson's Disease
Actual Study Start Date : January 29, 2018
Actual Primary Completion Date : February 12, 2018
Actual Study Completion Date : February 19, 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


  4. 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. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population will be selected from neurologic clinic.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03413787


Locations
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Turkey
Sevim ACARÖZ CANDAN
Ordu, Altinordu, Turkey, 52100
Sponsors and Collaborators
T.C. ORDU ÜNİVERSİTESİ
Investigators
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Principal Investigator: Sevim ACARÖZ CANDAN, PhD T.C. ORDU ÜNİVERSİTESİ

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Responsible Party: Sevim ACARÖZ CANDAN, Head of the Department of Physiotherapy and Rehabilitation, T.C. ORDU ÜNİVERSİTESİ
ClinicalTrials.gov Identifier: NCT03413787    
Other Study ID Numbers: Ordu2
First Posted: January 29, 2018    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Gait Disorders, Neurologic
Disease
Motor Disorders
Nervous System Diseases
Pathologic Processes
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders