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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Pediatric Demyelinating Disease Group |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No ADT | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Core Stability | 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) | 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) | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 30-Second Sit-to-Stand Test | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tahire Basak Demir, PhD (c) | Contact | +90 5394848542 | tahirebasakdemir@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Başakşehir Çam and Sakura City Hospital, Istanbul, Türkiye | Istanbul | Basaksehir | 34480 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28445083 | Background | 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. | |
| 27572866 |
| Label | URL |
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| Article | View source |
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No, individual participant data (IPD) will not be shared. All study records will be destroyed 2 years after study completion.
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| ID | Term |
|---|---|
| D003711 | Demyelinating Diseases |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Fatigue Severity Scale (FSS) | 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) | 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) |
| 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. |
| 26538849 | Background | 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. |
| Background | 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. |
| 31958274 | Background | 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. |
| 31516624 | Background | 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. |
| 32077065 | Background | 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. |
| Background | Al-Hameed, A. A. K. (2022). Spearman's correlation coefficient in statistical analysis. International Journal of Nonlinear Analysis and Applications, 13(1), 3249-3255. |
| 15034861 | Background | 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. |
| 21798048 | Background | 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. |
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| Article | View source |