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NCT Number: NCT03413787

The Türkish Version of the Freezing of Gait Questionnaire

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Gait Disorders, Neurologic Mental Disorders Motor Disorder Motor Disorders Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies

Sex eligibility

All sexes

Study type

Observational

Primary location

Sevim ACARÖZ CANDAN

Ordu, Altinordu, 52100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Ordu University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 29, 2018
Registry last updated
Mar 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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