Core Stability, Functional Capacity, Balance, Strength, and Fatigue in Pediatric Demyelinating Diseases (PEDI-CORE)
2026年9月4日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
観察的
入学 (推定)
32
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Tahire Basak Demir, PhD (c)
- 電話番号：203 +90 (212) 213 64 86
- メール：tahirebasakdemir@gmail.com
研究場所
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Basaksehir
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Istanbul、Basaksehir、トルコ（Türkiye）、34480
- Başakşehir Çam and Sakura City Hospital, Istanbul, Türkiye
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コンタクト：
- Tahire Basak Demir, PhD (c)
- 電話番号：203 +90 (212) 213 64 86
- メール：tahirebasakdemir@gmail.com
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
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.
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Core Stability
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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30-Second Sit-to-Stand Test
時間枠：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)
時間枠：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)
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年8月31日
一次修了 (推定)
2027年7月30日
研究の完了 (推定)
2028年1月30日
試験登録日
最初に提出
2026年6月12日
QC基準を満たした最初の提出物
2026年6月12日
最初の投稿 (実際)
2026年6月17日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月8日
QC基準を満たした最後の更新が送信されました
2026年9月4日
最終確認日
2026年9月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2025/451
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
No, individual participant data (IPD) will not be shared.
All study records will be destroyed 2 years after study completion.
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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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