Core Stability, Functional Capacity, Balance, Strength, and Fatigue in Pediatric Demyelinating Diseases (PEDI-CORE)
4 septembre 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Estimé)
32
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Tahire Basak Demir, PhD (c)
- Numéro de téléphone: 203 +90 (212) 213 64 86
- E-mail: tahirebasakdemir@gmail.com
Lieux d'étude
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Basaksehir
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Istanbul, Basaksehir, Turquie (Türkiye), 34480
- Başakşehir Çam and Sakura City Hospital, Istanbul, Türkiye
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Contact:
- Tahire Basak Demir, PhD (c)
- Numéro de téléphone: 203 +90 (212) 213 64 86
- E-mail: tahirebasakdemir@gmail.com
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
Accepte les volontaires sains
Non
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
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.
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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Group 1: Pediatric Demyelinating Disease Group
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Core Stability
Délai: 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.
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Baseline (single assessment)
|
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6-Minute Walk Test (6MWT)
Délai: Baseline (single assessment)
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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.
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Baseline (single assessment)
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Modified Star Excursion Balance Test (mSEBT)
Délai: Baseline (single assessment)
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The Modified Star Excursion Balance Test (mSEBT) will be used to assess dynamic postural control.
The test consists of three reach directions: anterior, posteromedial, and posterolateral, with the posterior directions positioned at 90° to each other and each forming a 135° angle with the anterior direction.
Participants will stand barefoot on the tested limb at the intersection of the three lines and reach as far as possible along each direction with the contralateral limb while maintaining balance and without transferring body weight onto the reaching limb.
Before testing, standardized practice trials will be provided to minimize learning effects.
Three recorded trials will be performed in each direction for each limb, and the maximum reach distance will be recorded.
Reach distances will be normalized to limb length and expressed as a percentage using the formula: (maximum reach distance / limb length) × 100.
A composite reach score will also be calculated by averaging the normalized
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Baseline (single assessment)
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Timed Up and Go Test (TUG)
Délai: Baseline (Single Assessment)
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For TUG, the person gets up from the chair, walks 3 m, turns back and sits down again.
The test will be conducted using the same chair for every child, and the time will be recorded in seconds.
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Baseline (Single Assessment)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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30-Second Sit-to-Stand Test
Délai: Baseline (single assessment)
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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.
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Baseline (single assessment)
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Fatigue Severity Scale (FSS)
Délai: Baseline (single assessment)
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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.
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Baseline (single assessment)
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Fatigue Numeric Rating Scale (NRS-Fatigue)
Délai: Past 24 hours and past 1 week (single assessment)
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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.
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Past 24 hours and past 1 week (single assessment)
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Erden A, Acar Arslan E, Dundar B, Topbas M, Cavlak U. Reliability and validity of Turkish version of pediatric balance scale. Acta Neurol Belg. 2021 Jun;121(3):669-675. doi: 10.1007/s13760-020-01302-9. Epub 2020 Feb 19.
- Gladman D, Nash P, Goto H, Birt JA, Lin CY, Orbai AM, Kvien TK. Fatigue numeric rating scale validity, discrimination and responder definition in patients with psoriatic arthritis. RMD Open. 2020 Jan;6(1):e000928. doi: 10.1136/rmdopen-2019-000928.
- Akuthota V, Nadler SF. Core strengthening. Arch Phys Med Rehabil. 2004 Mar;85(3 Suppl 1):S86-92. doi: 10.1053/j.apmr.2003.12.005.
- Toussaint-Duyster LC, Wong YYM, Van der Cammen-van Zijp MH, Van Pelt-Gravesteijn D, Catsman-Berrevoets CE, Hintzen RQ, Neuteboom RF. Fatigue and physical functioning in children with multiple sclerosis and acute disseminated encephalomyelitis. Mult Scler. 2018 Jun;24(7):982-990. doi: 10.1177/1352458517706038. Epub 2017 Apr 26.
- Tardieu M, Banwell B, Wolinsky JS, Pohl D, Krupp LB. Consensus definitions for pediatric MS and other demyelinating disorders in childhood. Neurology. 2016 Aug 30;87(9 Suppl 2):S8-S11. doi: 10.1212/WNL.0000000000002877.
- Gulati S, Chakrabarty B, Kumar A, Jain P, Patel H, Saini L. Acquired demyelinating disorders of central nervous system: A pediatric cohort. Ann Indian Acad Neurol. 2015 Sep;18(Suppl 1):S48-55. doi: 10.4103/0972-2327.164829.
- Hertel. J., Miller. S. J., Denegar. C. R. (2000). Intratester and intertester reliability during the star excursion balance tests. Journal of sport rehabilitation, 9-(2), 104-116.
- Gowda VK, Shetty D, Madivala BV, Benakappa N, Benakappa A. Clinical and Radiological Profiles, Treatment, and Outcome of Pediatric Acquired Demyelinating Disorders of Central Nervous System. J Pediatr Neurosci. 2019 Apr-Jun;14(2):76-81. doi: 10.4103/jpn.JPN_62_18.
- Al-Hameed, A. A. K. (2022). Spearman's correlation coefficient in statistical analysis. International Journal of Nonlinear Analysis and Applications, 13(1), 3249-3255.
- Absoud M, Cummins C, Chong WK, De Goede C, Foster K, Gunny R, Hemingway C, Jardine P, Kneen R, Likeman M, Lim MJ, Pike M, Sibtain N, Whitehouse WP, Wassmer E. Paediatric UK demyelinating disease longitudinal study (PUDDLS). BMC Pediatr. 2011 Jul 28;11:68. doi: 10.1186/1471-2431-11-68.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
31 août 2026
Achèvement primaire (Estimé)
30 juillet 2027
Achèvement de l'étude (Estimé)
30 janvier 2028
Dates d'inscription aux études
Première soumission
12 juin 2026
Première soumission répondant aux critères de contrôle qualité
12 juin 2026
Première publication (Réel)
17 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
8 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
4 septembre 2026
Dernière vérification
1 septembre 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2025/451
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
No, individual participant data (IPD) will not be shared.
All study records will be destroyed 2 years after study completion.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .