Core Stability, Functional Capacity, Balance, Strength, and Fatigue in Pediatric Demyelinating Diseases

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Core Stability [Срок оценки: Baseline (single assessment)]
• Star Excursion Balance Test (SEBT) [Срок оценки: Baseline (single assessment)]
• 6-Minute Walk Test (6MWT) [Срок оценки: Baseline (single assessment)]

Вторичные конечные точки (3)

• 30-Second Sit-to-Stand Test [Срок оценки: Baseline (single assessment)]
• Fatigue Severity Scale (FSS) [Срок оценки: Baseline (single assessment)]
• Fatigue Numeric Rating Scale (NRS-Fatigue) [Срок оценки: Past 24 hours and past 1 week (single assessment)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Turkey (Türkiye) · 1 центр

• Başakşehir Çam and Sakura City Hospital, Istanbul, Türkiye — Istanbul

Публикации

• 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. PMID 28445083
• 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. PMID 27572866
• 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. PMID 26538849
• 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.
• 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. PMID 31958274
• 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. PMID 31516624
• 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. PMID 32077065
• Al-Hameed, A. A. K. (2022). Spearman's correlation coefficient in statistical analysis. International Journal of Nonlinear Analysis and Applications, 13(1), 3249-3255.

Идентификаторы

NCT: NCT07654738 · 2025/451

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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