NCT05590533

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2022

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 21, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

October 21, 2022

Status Verified

October 1, 2022

Enrollment Period

5 months

First QC Date

October 19, 2022

Last Update Submit

October 19, 2022

Conditions

Cultural AdaptationReliabilityValidityMultiple SclerosisFatigue

Outcome Measures

Primary Outcomes (1)

  • F-2-MS Scale

    F-2-MS is a novel scale to assess fatigue and perceived fatigability in patients with MS

    10 minutes

Interventions

Cultural adaptation, reliability and validityOTHER

Cross-cultural Adaptation, Reliability and Validity of the Turkish Version of the F-2-MS

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple SclerosisFatigue

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Ayşe Ünal, Assoc. Prof.

CONTACT

+90(258)2964297pt.aunal@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

October 19, 2022

First Posted

October 21, 2022

Study Start

November 1, 2022

Primary Completion

April 1, 2023

Study Completion

May 1, 2023

Last Updated

October 21, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share