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Respiratory Functions in Pediatric-Onset Multiple Sclerosis

NCT ID: NCT05123924

Last Updated: 2021-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-29

Study Completion Date

2022-07-31

Brief Summary

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Pediatric-onset multiple sclerosis (POMS) is a chronic, autoimmune and inflammatory disease of the central nervous system that begins before the age of 18 years. POMS patients are affected in terms of physical capacity, cognitive status and fatigue compared with their healthy peers that has been reported. It has been reported that although individuals with MS with low disability levels do not have respiratory complaints, respiratory parameters may be affected. Therefore, it is necessary to evaluate respiratory capacity, respiratory muscle strength and fatigue levels of POMS patients. Evaluations will help prevent future complications by detecting any existing problems early.

Detailed Description

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People with pediatric onset multiple sclerosis (POMS) may experience sensory, motor, cerebellar and cognitive dysfunctions due to the destruction of the central nervous system. These disorders can cause decrease in physical capacity, increase in cognitive symptoms and fatigue level in patients with POMS. There is no study in the literature examining the relationship between respiratory capacity and respiratory muscle strength with fatigue in POMS patients. The aim of this study is to compare POMS patients and healthy controls in terms of respiratory capacity, respiratory muscle strength and fatigue. All participants's respiratory function will be evaluated with "Minispir Light Spirometer", respiratory muscle strength with "MD Diagnostics RP Check" and fatigue with Pediatric Quality of Life Inventory (PedsQL)-Multidimensional Fatigue Scale. Evaluations will not be repeated after a certain interval.As a result of the comparison of both groups, it will be determined whether POMS patients have difficulties or not.

Conditions

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Pediatric-onset Multiple Sclerosis

Keywords

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Pediatric-onset multiple sclerosis Physiotherapy Respiratory capacity Fatigue

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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POMS Group

Individuals in the POMS group will be evaluated in terms of respiratory capacity, respiratory muscle strength and fatigue.

Evaluation of respiratory capacity, respiratory muscle strength and fatigue

Intervention Type OTHER

The demographic information of the participants will be taken with the form prepared for the people in this group. Then, respiratory function with "Minispir Light Spirometer", respiratory muscle strength with "MD Diagnostics RP Check" and fatigue with Pediatric Quality of Life Inventory (PedsQL)-Multidimensional Fatigue Scale will be evaluated. All assessments will be completed on the same day and will not be repeated after a certain period of time.

Control Group

Individuals in the control group will be evaluated in terms of respiratory capacity, respiratory muscle strength and fatigue.

Evaluation of respiratory capacity, respiratory muscle strength and fatigue

Intervention Type OTHER

The demographic information of the participants will be taken with the form prepared for the people in this group. Then, respiratory function with "Minispir Light Spirometer", respiratory muscle strength with "MD Diagnostics RP Check" and fatigue with Pediatric Quality of Life Inventory (PedsQL)-Multidimensional Fatigue Scale will be evaluated. All assessments will be completed on the same day and will not be repeated after a certain period of time.

Interventions

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Evaluation of respiratory capacity, respiratory muscle strength and fatigue

The demographic information of the participants will be taken with the form prepared for the people in this group. Then, respiratory function with "Minispir Light Spirometer", respiratory muscle strength with "MD Diagnostics RP Check" and fatigue with Pediatric Quality of Life Inventory (PedsQL)-Multidimensional Fatigue Scale will be evaluated. All assessments will be completed on the same day and will not be repeated after a certain period of time.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Volunteer to participate
* Being diagnosed with pediatric onset multiple sclerosis
* Being between the ages of 15-22
* EDSS \<6

Exclusion Criteria

* Having another diagnosis in addition to the diagnosis of pediatric-onset multiple sclerosis
* Having a blurred vision problem
* Having had an attack or received corticosteroid treatment 3 months before participating in the study
Minimum Eligible Age

15 Years

Maximum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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Yonca Zenginler Yazgan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Buket Akıncı, Assoc. Prof.

Role: STUDY_CHAIR

Biruni University

Pelin Vural, MSc.

Role: STUDY_CHAIR

Istanbul University-Cerrahpasa, Graduate Education Institute

Serhat Güler, MD

Role: STUDY_CHAIR

Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine, Department of Pediatric Neurology

Locations

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Istanbul University-Cerrahpasa

Istanbul, Bakırköy, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Yonca Zenginler Yazgan, PhD

Role: CONTACT

Email: [email protected]

Pelin Vural, MSc.

Role: CONTACT

Phone: +905344245350

Email: [email protected]

Facility Contacts

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Yonca Zenginler Yazgan, PhD

Role: primary

References

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Vural P, Akinci B, Guler S, Saltik S, Yazgan YZ. Respiratory functions, respiratory muscle strength and fatigue in patients with pediatric-onset multiple sclerosis: a comparative cross-sectional study. Acta Neurol Belg. 2025 Feb;125(1):69-75. doi: 10.1007/s13760-024-02628-4. Epub 2024 Aug 21.

Reference Type DERIVED
PMID: 39168946 (View on PubMed)

Other Identifiers

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IUC-2021-68

Identifier Type: -

Identifier Source: org_study_id