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Core Stability, Functional Capacity, Balance, Strength, and Fatigue in Pediatric Demyelinating Diseases (PEDI-CORE)

12. juni 2026 opdateret af: Tahire Basak Demir, Istanbul University - Cerrahpasa

Investigation of the Relationship Between Core Stability, Functional Capacity, Balance, Lower Extremity Strength, and Fatigue in Pediatric Demyelinating Diseases

This study aims to evaluate balance ability, core stability, functional capacity, lower extremity muscle strength, and fatigue levels in children diagnosed with central nervous system demyelinating diseases, in order to contribute to the development of evidence-based and individualized rehabilitation strategies.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Central nervous system demyelinating diseases in childhood, including multiple sclerosis, neuromyelitis optica spectrum disorder, and acute disseminated encephalomyelitis, are rare but may result in significant physical and cognitive impairments. These conditions arise from immune-mediated damage to the white matter of the brain, optic nerve, and spinal cord, leading to disruptions in neuromotor development.

Motor dysfunction, fatigue, and reduced physical activity are commonly observed in affected children and are associated with decreased functional capacity and quality of life. In addition, impaired postural stability due to disrupted integration of proprioceptive, vestibular, and visual systems contributes to balance deficits, increased fall risk, gait abnormalities, and reduced participation in daily activities.

Core stabilization plays a fundamental role in motor development and functional movement by ensuring efficient postural control and force transfer through the kinetic chain. However, central nervous system pathology may impair the timely and coordinated activation of core musculature.

Despite growing literature in adult populations, pediatric evidence remains limited, which restricts the development of individualized rehabilitation approaches. Therefore, this study will assess balance, core stability, functional capacity, lower extremity muscle strength, and fatigue in children with demyelinating diseases to better inform clinical rehabilitation strategies.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

32

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Tyrkiet (Türkiye)
    • Basaksehir
      • Istanbul, Basaksehir, Tyrkiet (Türkiye), 34480
        • Başakşehir Çam and Sakura City Hospital, Istanbul, Türkiye
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

The study will be conducted with pediatric patients diagnosed with demyelinating diseases (Multiple Sclerosis (MS), Acute Disseminated Encephalomyelitis (ADEM), Neuromyelitis Optica Spectrum Disorder (NMOSD), and Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)) who are referred to our center.

Beskrivelse

Inclusion Criteria:

  • Age between 6 and 18 years
  • Diagnosed with a pediatric demyelinating disease
  • No relapse within the last 3 months
  • No botulinum toxin (Botox) injections within the last 3 months
  • No corticosteroid treatment within the last 3 months
  • Ability to read and write

Exclusion Criteria:

  • History of concomitant autoimmune diseases
  • Refusal of the patient and/or caregiver to participate in the study
  • History of another primary neurological disease
  • Cognitive impairment that limits understanding of instructions and participation in assessments
  • Visual and/or hearing impairments that interfere with activities of daily living
  • Presence of additional rheumatological conditions that may interfere with assessments
  • Spasticity grade ≥2 according to the Modified Ashworth Scale in any muscle group

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Group 1: Pediatric Demyelinating Disease Group
Andet: No ADT
No intervention is administered. Participants will undergo a single assessment including balance evaluation, core stability testing, lower extremity muscle strength assessment, functional capacity tests, and fatigue measurement. All assessments are non-invasive and performed in a single session.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Core Stability
Tidsramme: Baseline (single assessment)
Core stability (endurance and strength) will be evaluated using standardized trunk endurance tests. The Trunk Flexor Endurance Test measures the duration participants can maintain a 60° trunk flexion position. The Biering-Sørensen Test evaluates trunk extensor endurance in a prone horizontal position supported at the pelvis and lower limbs, recording the time until loss of horizontal alignment. The Side Bridge Test assesses lateral trunk endurance while maintaining a side plank position. All results will be recorded in seconds.
Baseline (single assessment)
Star Excursion Balance Test (SEBT)
Tidsramme: Baseline (single assessment)
Balance will be assessed using the Star Excursion Balance Test (SEBT), a functional single-leg balance test performed on a grid with eight directional reach lines (anterior, anterolateral, lateral, posterolateral, posterior, posteromedial, medial, and anteromedial). Participants will maintain a single-leg stance while reaching maximally in each direction with the contralateral limb. Each direction will be repeated six times, with the best three trials averaged for analysis. Standardized verbal and visual instructions will be provided.
Baseline (single assessment)
6-Minute Walk Test (6MWT)
Tidsramme: Baseline (single assessment)
Functional capacity will be assessed using the 6-Minute Walk Test (6MWT) following standardized protocols. Participants will walk at their own pace for 6 minutes on a 30-meter indoor walkway marked every 2 meters, with turnaround points marked by cones. The total distance walked in meters will be recorded.
Baseline (single assessment)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
30-Second Sit-to-Stand Test
Tidsramme: Baseline (single assessment)
Lower extremity muscle strength and functional performance will be assessed using the 30-Second Sit-to-Stand Test. Participants will perform repeated sit-to-stand movements from a standardized chair for 30 seconds. The total number of full stands completed within the time period will be recorded.
Baseline (single assessment)
Fatigue Severity Scale (FSS)
Tidsramme: Baseline (single assessment)
Fatigue severity will be assessed using the Fatigue Severity Scale (FSS), a 9-item questionnaire rated on a 7-point Likert scale (1 = strongly disagree, 7 = strongly agree). The final score is calculated as the mean of all items, with higher scores indicating greater fatigue severity.
Baseline (single assessment)
Fatigue Numeric Rating Scale (NRS-Fatigue)
Tidsramme: Past 24 hours and past 1 week (single assessment)
Fatigue intensity will be measured using a 0-10 Numeric Rating Scale, where 0 indicates no fatigue and 10 indicates worst imaginable fatigue. Participants will report fatigue levels during activity, at rest, and over the last 24 hours, as well as perceived fatigue over the past week.
Past 24 hours and past 1 week (single assessment)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Istanbul University - Cerrahpasa

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

30. juli 2026

Primær færdiggørelse (Anslået)

30. juli 2027

Studieafslutning (Anslået)

30. januar 2028

Datoer for studieregistrering

Først indsendt

12. juni 2026

Først indsendt, der opfyldte QC-kriterier

12. juni 2026

Først opslået (Faktiske)

17. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2025/451

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

No, individual participant data (IPD) will not be shared. All study records will be destroyed 2 years after study completion.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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