Reliability and Validity of the Turkish Version of Caregi... | NCT03130075

Studies
Reliability and Validity of the Turkish Version of Caregiver Functional Use Survey (CFUS)

NCT03130075

Sponsor

Gazi University

Status

Unknown status

Last Update Posted

May 30, 2017Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Cerebral Palsy

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2, 2017Actual

Primary Completion Date

Jul 25, 2017Estimated

Completion Date

Aug 25, 2017Estimated

First Submitted Date

Apr 21, 2017

First Submission Date that Met QC Criteria

Apr 25, 2017

First Posted Date

Apr 26, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 26, 2017

Last Update Posted Date

May 30, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Increasing the number of Turkish version of the questionnaire evaluating hand use, adding the scales that evaluate the selective movements of the upper limb to the evaluations will increase the variety of evaluation methods.

The purpose of this study is to evaluate the validity and reliability of the Turkish version of the Caregiver Functional Use Survey (CFUS)

Detailed Description

CFUS was designed to assess caregivers' perceptions of how much and how well their child used the involved upper extremity.

Children's upper extremity functions will be assessed with a Jebsen Taylor Hand Function Test. Their family will be asked to fill the CFUS.

Compare the relationship between Jebsen-Taylor Hand Function Test and Turkish Version CFUS. Investigate the internal consistency of Turkish-version of CFUS by using Cronbach's alpha coefficient.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Validity of Caregiver Functional Use Survey (CFUS)	Compare the relationship between Jebsen-Taylor Hand Function Test and Turkish Version CFUS	8 week

Secondary Outcomes

Measure	Description	Time Frame
Reliability of CFUS	Investigate the internal consistency of Turkish-version of CFUS by using Cronbach's alpha coefficient.	8 week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ages between 3-15 years
Diagnosed as Cerebral Palsy (Hemiplegia)
Literate in Turkish language and can complete the questionnaire by primer caregiver

Exclusion Criteria:

Cannot understand the questionnaire by themselves.
Participants had a botulinum toxin injection within the last 6 months
Any surgical correction within the last year

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

Children with Hemiplegia Cerebral Palsy

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bülent Elbasan	Study chair	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gazi University		Ankara		06560	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002547	Cerebral Palsy

Ancestor Terms

ID	Term
D001925	Brain Damage, Chronic
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided