Vestibular Stimulation Versus Foot Intrinsic Muscle Exercises in Children With Down Syndrome (VESTIB-FIME)
Effects of Vestibular Stimulation VS Foot Intrinsic Muscles Exercises on Balance and Functional Mobility in Children With Down's Syndrome
調査の概要
状態
詳細な説明
Down syndrome (DS) is a genetic disorder commonly associated with hypotonia, ligamentous laxity, impaired postural control, motor incoordination, and balance difficulties. These impairments can negatively affect functional mobility and participation in activities of daily living. Balance is one of the major functional domains affected in children and adolescents with Down syndrome. Postural instability may result in increased displacement of the center of mass during gait and center of pressure during standing, which can further affect gait performance, transfers, and other functional activities.
Pes planus (flat foot) is also frequently observed in individuals with Down syndrome and may contribute to impaired balance, physical activity, and quality of life. Vestibular stimulation exercises (VSE) provide repetitive sensory information regarding body position, movement, and orientation in space and may improve postural control and balance. Similarly, foot intrinsic muscle exercises (FIMEs) aim to strengthen the muscles responsible for foot stability and may improve foot function, postural control, gait, and functional mobility.
Previous studies have reported beneficial effects of vestibular stimulation and foot intrinsic muscle exercises when used independently in individuals with Down syndrome or balance-related impairments. However, there is limited research directly comparing these two approaches in children with Down syndrome. Therefore, this study will compare the effects of vestibular stimulation exercises and foot intrinsic muscle exercises on balance and functional mobility in children aged 4-15 years with Down syndrome.
Balance will be assessed using the Pediatric Balance Scale (PBS), while functional mobility will be evaluated using the Timed Up and Go (TUG) test. The study aims to determine which intervention provides greater improvement in balance and functional mobility. The findings may help physiotherapists and rehabilitation professionals select an appropriate exercise approach for children with Down syndrome and contribute to the development of more effective pediatric rehabilitation strategies.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：laiba shad, DPT
- 電話番号：03066493073
- メール：laibashad27@gmail.com
研究連絡先のバックアップ
- 名前：arooj hanif, DPT
- 電話番号：03206550216
- メール：aroojhanif6@gmail.com
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:
- • Children with Down syndrome with age range (4-15 years) both male and female children included [12]. • Children who are able to stand and walk/ambulate independently and follow verbal instructions and commands and comply with intervention protocol [13]. • No visual and hearing impairment • Parent/guardian willing to provide consent for participant
Exclusion Criteria:
- Associated congenital heart disease • Hearing impairment, eye problems such as cataract or other visual impairment • Dementia and cognitive decline. • Lower limb trauma or surgical intervention within the previous 6 months affecting comprehension or ability to perform balance/mobility activities [13]
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：ランダム化
- 介入モデル：並列代入
- 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：Vestibular Stimulation Exercise Group
Participants in this group will receive vestibular stimulation exercises 3 times per week for 8 weeks, for a total of 24 sessions.
Each session will last 20 minutes, with a 5-minute rest interval.
The intervention will include spinning while sitting on a Swiss ball, sliding while lying on a large roller pillow, and vertical bouncing while sitting on a roller.
Balance and functional mobility will be assessed at baseline (Week 0), immediately after the intervention (Week 8), and at follow-up (Week 12).
Balance will be measured using the Pediatric Balance Scale (PBS), and functional mobility will be assessed using the Timed Up and Go (TUG) test.
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A structured vestibular stimulation exercise program designed to improve postural control, balance, and functional mobility in children with Down syndrome.
The program includes sensory-motor activities involving controlled rotational, linear, and vertical movements.
他の名前：
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実験的：Foot Intrinsic Muscle Exercises
Participants in this group will receive foot intrinsic muscle exercises 3 times per week for 8 weeks, for a total of 24 sessions.
Each session will last 20 minutes, with a 5-minute rest interval.
The intervention will include toe curls, marble pickups, short foot exercises, ball rolling, heel raises, step-ups, and football kicking.
Seated calf stretching will be performed as a warm-up and cool-down before and after strengthening exercises.
Balance and functional mobility will be assessed at baseline (Week 0), immediately after the intervention (Week 8), and at follow-up (Week 12).
Balance will be measured using the Pediatric Balance Scale (PBS), and functional mobility will be assessed using the Timed Up and Go (TUG) test.
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A structured foot muscle strengthening program designed to improve foot stability, postural control, balance, and functional mobility in children with Down syndrome.
The program targets the intrinsic muscles of the foot through functional strengthening activities.
他の名前：
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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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Change in Balance Measured by the Pediatric Balance Scale (PBS)
時間枠：Baseline (Week 0), immediately post-intervention (Week 8), and follow-up (Week 12)
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Balance will be assessed using the Pediatric Balance Scale (PBS), a 14-item clinical measure of functional balance in children.
The total score ranges from 0 to 56, with higher scores indicating better balance.
The change in PBS score from baseline will be evaluated to determine the effect of the interventions on balance.
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Baseline (Week 0), immediately post-intervention (Week 8), and follow-up (Week 12)
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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 |
|---|---|---|
|
Change in Functional Mobility Measured by the Timed Up and Go (TUG) Test
時間枠：Baseline (Week 0), immediately post-intervention (Week 8), and follow-up (Week 12)
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Functional mobility will be assessed using the Timed Up and Go (TUG) test.
The TUG measures the time, in seconds, required for a participant to stand up from a chair, walk 3 meters, turn around, walk back, and sit down.
A shorter completion time indicates better functional mobility.
The change in TUG completion time from baseline will be evaluated.
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Baseline (Week 0), immediately post-intervention (Week 8), and follow-up (Week 12)
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協力者と研究者
捜査官
- スタディチェア：DR SADAF TABASSAM, PHD、Shalamar Hospital
出版物と役立つリンク
一般刊行物
- Bu Q, Qiang R, Cheng H, et al. Front Pediatr. 2022;10:882722. Khan F, Rahiyab M, Hussain I, et al. Int Health Rev. 2025;5(2):19-44. Giustino V, Messina G, Alesi M, et al. Hum Mov. 2021;22(1):66-71. Nahla IM, El-Sayed SE, Ragaa AE, et al. Afr Health Sci. 2022;22(1):377-383. Tuncer D, Erekdag A, Senaran H, et al. Eur J Pediatr. 2025;184:636. Halwsh SD, Algabbani MF, Alqabbani S, et al. Brain Sci. 2026;16(1):79. Siddiqui M, Farooqui S, Rizvi J, et al. Ann King Edward Med Univ. 2024;30(2):112-118. Ghouri EURK, Memon AG, Ali S, et al. J Liaquat Univ Med Health Sci. 2024;23(2):116-120. Adeeba N, Farooqui SI, Hasan ZM, et al. Dev Neurorehabil. 2024;27(5-6):145-153.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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
- SSAHS-2026-1126
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
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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