Turkish Version of F-2-MS | NCT05590533

Studies
Turkish Version of F-2-MS

NCT05590533

Sponsor

Pamukkale University

Status

Unknown status

Last Update Posted

Oct 21, 2022Actual

Enrollment

180Estimated

Phase

Not provided

Conditions

Cultural Adaptation
Reliability
Validity
Multiple Sclerosis
Fatigue

Interventions

Cultural adaptation, reliability and validity

Countries

Not provided

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

Oct 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2022Estimated

Primary Completion Date

Apr 2023Estimated

Completion Date

May 2023Estimated

First Submitted Date

Oct 19, 2022

First Submission Date that Met QC Criteria

Oct 19, 2022

First Posted Date

Oct 21, 2022Actual

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

Oct 19, 2022

Last Update Posted Date

Oct 21, 2022Actual

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

The aims of this study were to perform cultural adaptation of the F-2-MS and provide information regarding the factor structure, reliability and validity of the instrument in Turkish speaking patients with Multiple Sclerosis.

Detailed Description

Not provided

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

180Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cultural adaptation, reliability and validity	Other	Cross-cultural Adaptation, Reliability and Validity of the Turkish Version of the F-2-MS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
F-2-MS Scale	F-2-MS is a novel scale to assess fatigue and perceived fatigability in patients with MS	10 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Individuals aged between 20-65 years, with an EDSS score of 0-5, who have not had an attack in the last 2 months, who have no cognitive problems (a score of 6 or more according to the Hodkinson Mental Test), who do not have additional neurological diseases other than MS, and who volunteer to participate in the study will be included.

Exclusion Criteria:

Individuals with an EDSS score greater than 5, who are in the attack period, who have vestibulosupressant or drug or alcohol use habits that cause neuropathy, and who have communication problems will be excluded from the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Adults with multiple sclerosis with an EDSS score of 5 or less

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ayşe Ünal, Assoc. Prof.	Contact	+90(258)2964297		pt.aunal@gmail.com

Overall Officials

Not provided

Locations

Not provided

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
D009103	Multiple Sclerosis
D005221	Fatigue

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Browse Leaves

Not provided

Browse Branches

Not provided