Core Stability, Functional Capacity, Balance, Strength, and Fatigue in Pediatric Demyelinating Diseases (PEDI-CORE)
4 de setembro de 2026 atualizado por: 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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Observacional
Inscrição (Estimado)
32
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Tahire Basak Demir, PhD (c)
- Número de telefone: 203 +90 (212) 213 64 86
- E-mail: tahirebasakdemir@gmail.com
Locais de estudo
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Basaksehir
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Istanbul, Basaksehir, Turquia (Türkiye), 34480
- Başakşehir Çam and Sakura City Hospital, Istanbul, Türkiye
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Contato:
- Tahire Basak Demir, PhD (c)
- Número de telefone: 203 +90 (212) 213 64 86
- E-mail: tahirebasakdemir@gmail.com
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
Aceita Voluntários Saudáveis
Não
Método de amostragem
Amostra Não Probabilística
População do estudo
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.
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Core Stability
Prazo: Baseline (single assessment)
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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)
Prazo: 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)
Prazo: 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)
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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30-Second Sit-to-Stand Test
Prazo: 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)
Prazo: 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)
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
31 de agosto de 2026
Conclusão Primária (Estimado)
30 de julho de 2027
Conclusão do estudo (Estimado)
30 de janeiro de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
12 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
12 de junho de 2026
Primeira postagem (Real)
17 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
8 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
4 de setembro de 2026
Última verificação
1 de setembro de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2025/451
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
No, individual participant data (IPD) will not be shared.
All study records will be destroyed 2 years after study completion.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .