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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Istanbul、トルコ（Türkiye）
- Tek Metod Special Education and Rehabilitation Center
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参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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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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Balance Performance
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Functional Mobility
時間枠：Baseline and 8 weeks
|
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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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
- OÖA_OAS
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?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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