The Türkish Version of the Freezing of Gait Questionnaire

Parkinson Disease Clinical Trial

Official title:

The Türkish Version of the Freezing of Gait Questionnaire in Patients With Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03413787
• Other study ID #: Ordu2
• Status: Completed
• First received: January 22, 2018
• Last updated: March 21, 2018
• Start date: January 29, 2018
• Est. completion date: February 19, 2018

Study information

• Verified date: March 2018
• Source: T.C. ORDU ÜNIVERSITESI
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 19, 2018
• Est. primary completion date: February 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Gait Disorders, Neurologic
• Motor Disorder
• Motor Disorders
• Nervous System Diseases
• Parkinson Disease

Locations

Country	Name	City	State
Turkey	Sevim ACARÖZ CANDAN	Ordu	Altinordu

Sponsors (1)

Lead Sponsor	Collaborator
T.C. ORDU ÜNIVERSITESI

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	5 minutes
Secondary	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.	5 minutes
Secondary	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.	10 minutes
Secondary	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.	2 minutes
Secondary	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.	5 minutes
Secondary	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.	2 minutes