Neurodevelopmental Treatment for Balance and Mobility in Children With Down Syndrome
Effects of Neurodevelopmental Treatment on Balance, Mobility, Walking Capacity, and Functional Independence in Children With Down Syndrome: A Pilot Pre-Post Intervention Study
The goal of this clinical trial is to evaluate whether Neurodevelopmental Treatment (NDT) can improve balance, mobility, walking capacity, and functional independence in preschool children with Down syndrome.
The main questions it aims to answer are:
- Does an 8-week Neurodevelopmental Treatment program improve balance performance in children with Down syndrome?
- Does Neurodevelopmental Treatment improve mobility, walking capacity, functional independence, and gross motor function in children with Down syndrome?
- Are baseline balance performance and age of independent standing associated with treatment-related balance improvements?
All participants will receive individualized Neurodevelopmental Treatment based on the Bobath concept twice weekly for 8 weeks.
Participants will:
- Undergo baseline assessments of balance, mobility, walking capacity, functional independence, and gross motor function
- Participate in individualized Neurodevelopmental Treatment sessions twice weekly for 8 weeks
- Complete the same outcome assessments following the intervention period
The findings may help improve understanding of rehabilitation outcomes and factors associated with treatment responsiveness in children with Down syndrome.
研究概览
详细说明
Down syndrome (DS) is one of the most common genetic conditions associated with intellectual disability and is frequently accompanied by motor impairments, including hypotonia, ligamentous laxity, delayed motor development, impaired balance, and reduced functional mobility. These impairments may negatively affect participation in daily activities and functional independence during childhood.
Neurodevelopmental Treatment (NDT), also known as the Bobath concept, is widely used in pediatric rehabilitation to facilitate postural control, movement quality, sensory-motor integration, and functional performance. Although NDT is commonly applied in clinical practice, evidence regarding its effects on balance, mobility, walking capacity, and functional independence in children with Down syndrome remains limited.
This pilot study was designed to investigate changes in motor and functional outcomes following an individualized 8-week NDT program in preschool children with Down syndrome. In addition to evaluating intervention-related changes, the study explored whether baseline balance performance and age of independent standing were associated with treatment responsiveness. Understanding factors that may influence rehabilitation outcomes could support more individualized treatment planning and improve clinical decision-making in pediatric rehabilitation.
The findings of this study are expected to provide preliminary evidence regarding the potential role of NDT in improving functional outcomes in children with Down syndrome and to inform the design of future controlled rehabilitation trials.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Istanbul、土耳其（türkiye）
- Tek Metod Special Education and Rehabilitation Center
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参与标准
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
描述
Inclusion Criteria:
Diagnosis of Down syndrome Age between 3 and 6 years Gross Motor Function Classification System (GMFCS) Level I or II Ability to walk independently without assistive devices Ability to cooperate with assessment and treatment procedures Parent or legal guardian willing to provide informed consent
Exclusion Criteria:
Severe visual impairment Diagnosis of autism spectrum disorder Significant cooperation difficulties preventing participation in assessments or treatment Failure to regularly attend the physiotherapy program Lower-extremity surgery within the previous 6 months Any medical condition that would prevent safe participation in the intervention program
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Neurodevelopmental Treatment
Participants received individualized Neurodevelopmental Treatment (NDT) based on the Bobath concept twice weekly for 8 weeks.
Each treatment session lasted approximately 55-60 minutes and included balance training, postural control exercises, weight-shifting activities, gait training, trunk control exercises, functional reaching activities, stair negotiation practice, and task-oriented functional activities tailored to each child's abilities and needs.
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Neurodevelopmental Treatment (NDT) based on the Bobath concept was delivered individually twice weekly for 8 weeks.
Treatment sessions focused on improving postural control, balance, mobility, motor performance, and functional independence through task-oriented activities, therapist facilitation techniques, and sensory-motor stimulation.
Intervention content was individualized according to each participant's motor abilities and functional needs.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Balance Performance
大体时间：Baseline and 8 weeks
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Balance performance assessed using the Pediatric Balance Scale (PBS).
The PBS consists of 14 items scored from 0 to 4, with a total score ranging from 0 to 56.
Higher scores indicate better balance performance.
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Baseline and 8 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Functional Mobility
大体时间：Baseline and 8 weeks
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Functional mobility assessed using the Modified Timed Up and Go Test (mTUG).
The time required to complete the test is recorded in seconds.
Lower completion times indicate better functional mobility.
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Baseline and 8 weeks
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Walking Capacity
大体时间：Baseline and 8 weeks
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Walking capacity assessed using the One-Minute Walk Test (1MWT).
Total walking distance covered in one minute is recorded in meters.
Greater walking distance indicates better walking capacity.
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Baseline and 8 weeks
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Functional Independence
大体时间：Baseline and 8 weeks
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Functional independence assessed using the Pediatric Functional Independence Measure (WeeFIM).
The WeeFIM contains 18 items scored on a 7-point scale, yielding a total score ranging from 18 to 126.
Higher scores indicate greater functional independence.
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Baseline and 8 weeks
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Gross Motor Function Level
大体时间：Baseline and 8 weeks
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Gross motor function level assessed using the Gross Motor Function Classification System (GMFCS).
The GMFCS classifies motor function into five levels (Level I-V), with Level I representing the highest level of motor function and Level V representing the lowest level of motor function.
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Baseline and 8 weeks
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合作者和调查者
出版物和有用的链接
一般刊物
- Zago M, Duarte NAC, Grecco LAC, Condoluci C, Oliveira CS, Galli M. Gait and postural control patterns and rehabilitation in Down syndrome: a systematic review. J Phys Ther Sci. 2020 Apr;32(4):303-314. doi: 10.1589/jpts.32.303. Epub 2020 Apr 2.
- Jain PD, Nayak A, Karnad SD, Doctor KN. Gross motor dysfunction and balance impairments in children and adolescents with Down syndrome: a systematic review. Clin Exp Pediatr. 2022 Mar;65(3):142-149. doi: 10.3345/cep.2021.00479. Epub 2021 Jun 11.
- Tekin F, Kavlak E, Cavlak U, Altug F. Effectiveness of Neuro-Developmental Treatment (Bobath Concept) on postural control and balance in Cerebral Palsied children. J Back Musculoskelet Rehabil. 2018;31(2):397-403. doi: 10.3233/BMR-170813.
- Demir-Er Ş, Alkan H, Topuz S, et al. Gait and static balance analysis of children with Down syndrome and comparison with typically developing children. Int J Dev Disabil. Epub ahead of print 2025. DOI: 10.1080/20473869.2025.2496723.
- Rodriguez-Grande EI, Buitrago-Lopez A, Torres-Narvaez MR, Serrano-Villar Y, Verdugo-Paiva F, Avila C. Therapeutic exercise to improve motor function among children with Down Syndrome aged 0 to 3 years: a systematic literature review and meta-analysis. Sci Rep. 2022 Jul 29;12(1):13051. doi: 10.1038/s41598-022-16332-x.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- OÖA_OAS
计划个人参与者数据 (IPD)
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IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
- 树液
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