NCT03413787

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 29, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

January 29, 2018

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2018

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2018

Completed
Last Updated

March 23, 2018

Status Verified

March 1, 2018

Enrollment Period

14 days

First QC Date

January 22, 2018

Last Update Submit

March 21, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Unified Parkinson's Disease Rating Scale-part III

    5 minutes

  • Berg Balance Scale

    10 minutes

  • Timed up and go test

    2 minutes

  • Fall Efficacy Scale

    5 minutes

  • Hoehn and Yahr Scale

    2 minutes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population will be selected from neurologic clinic.

You may qualify if:

  • a clinical diagnosis of idiopathic PD
  • able to walk with or without a walking device

You may not qualify if:

  • a diagnosis of other neurological disorders
  • any other medical conditions
  • not able to take commands.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sevim ACARÖZ CANDAN

Ordu, Altinordu, 52100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parkinson DiseaseMotor DisordersGait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sevim ACARÖZ CANDAN, PhD

    Ordu University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Department of Physiotherapy and Rehabilitation

Study Record Dates

First Submitted

January 22, 2018

First Posted

January 29, 2018

Study Start

January 29, 2018

Primary Completion

February 12, 2018

Study Completion

February 19, 2018

Last Updated

March 23, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations