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临床试验/NCT07654738
NCT07654738尚未招募不适用

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

Istanbul University - Cerrahpasa1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2026年8月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
32
试验地点
1
主要终点
Modified Star Excursion Balance Test (mSEBT)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Group 1: Pediatric Demyelinating Disease Group

干预措施: No ADT (Other)

结局指标

主要结局

Modified Star Excursion Balance Test (mSEBT)

时间窗: 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

Timed Up and Go Test (TUG)

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Istanbul University - Cerrahpasa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tahire Basak Demir

PhD (c)

Istanbul University - Cerrahpasa

研究点 (1)

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