Core Stability, Functional Capacity, Balance, Strength, and Fatigue in Pediatric Demyelinating Diseases (PEDI-CORE)
4 de septiembre de 2026 actualizado 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
De observación
Inscripción (Estimado)
32
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Tahire Basak Demir, PhD (c)
- Número de teléfono: 203 +90 (212) 213 64 86
- Correo electrónico: tahirebasakdemir@gmail.com
Ubicaciones de estudio
-
-
Basaksehir
-
Istanbul, Basaksehir, Turquía (Türkiye), 34480
- Başakşehir Çam and Sakura City Hospital, Istanbul, Türkiye
-
Contacto:
- Tahire Basak Demir, PhD (c)
- Número de teléfono: 203 +90 (212) 213 64 86
- Correo electrónico: tahirebasakdemir@gmail.com
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Group 1: Pediatric Demyelinating Disease Group
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Core Stability
Periodo de tiempo: 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)
|
|
6-Minute Walk Test (6MWT)
Periodo de tiempo: 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)
|
|
Modified Star Excursion Balance Test (mSEBT)
Periodo de tiempo: Baseline (single assessment)
|
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
|
Baseline (single assessment)
|
|
Timed Up and Go Test (TUG)
Periodo de tiempo: Baseline (Single Assessment)
|
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.
|
Baseline (Single Assessment)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
30-Second Sit-to-Stand Test
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
31 de agosto de 2026
Finalización primaria (Estimado)
30 de julio de 2027
Finalización del estudio (Estimado)
30 de enero de 2028
Fechas de registro del estudio
Enviado por primera vez
12 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
12 de junio de 2026
Publicado por primera vez (Actual)
17 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
8 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
4 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2025/451
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
No, individual participant data (IPD) will not be shared.
All study records will be destroyed 2 years after study completion.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .