Core Strength for Head Control and Quality of Life in Cerebral Palsy
2026年5月24日 更新者：Tamer Mohamed El-Saeed、Cairo University
Effect of Core Strength Training on Head and Trunk Control and Quality of Life in Spastic Cerebral Palsy
The goal of this observational study is to examine the effect of an 8-week therapist-assisted core muscle strengthening program on head control, trunk stability, functional core strength, quality of life, and automatic righting reactions in non-ambulatory children with spastic cerebral palsy. The main questions it aims to answer are:
- Does head control improve over time in supine, prone, and supported sitting?
- Does segmental trunk control improve across static, active, and reactive tasks?
- Does functional cervico-trunk strength improve?
- Do automatic righting reactions change after the intervention?
Participants will:
- Take part in 24 therapy sessions over 8 weeks.
- Receive therapist-assisted core activation exercises such as bridging, modified quadruped over a bolster, supported sitting on a therapy ball with multidirectional perturbations, and assisted pull-to-sit.
- Complete assessments at baseline, week 4, and week 8 for head control, trunk control, functional strength, and righting reactions.
Researchers will compare participants' outcomes across baseline, mid-intervention, and post-intervention time points to see whether the program is associated with improvements in motor control and function.
調査の概要
研究の種類
介入
入学 (実際)
38
段階
- 適用できない
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。
研究場所
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Jeddah、サウジアラビア
- Faculty of Medical Rehabilitation Sciences
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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
健康ボランティアの受け入れ
いいえ
説明
Inclusion criteria
- Confirmed medical diagnosis of spastic cerebral palsy.
- Chronological age 4-10 years.
- GMFCS Level IV or V.
- Demonstrated impairment of head control, operationalized as a Head Control Scale score of 1 or 2 in prone, supine, or supported sitting at screening, ensuring measurable baseline deficit with biological capacity for improvement.
- Sufficient receptive cognitive and language capacity to attempt simple, modified therapeutic instructions (e.g., 'look up,' 'hold').
Exclusion criteria
- Fixed structural spinal deformity, defined as Cobb angle > 30° on most recent radiographic assessment.
- Orthopedic surgery within the preceding 12 months.
- Botulinum toxin type-A (BoNT-A) injection to trunk or cervical musculature within the preceding 6 months.
- Uncontrolled seizure disorder posing safety risk during physical exertion.
- Uncorrected severe visual or auditory impairment precluding response to therapeutic stimuli.
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
- 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：Core Strength Training
The group received Physical therapy program in addition to core strength training to investigate the head and trunk control as well as quality of life.
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The intervention comprised 24 sessions (3 × 45-50 min weekly) of warm-up, therapist-assisted core activation (bridging, modified quadruped over bolster, supported sitting on therapy ball with multidirectional perturbations, assisted pull-to-sit), and cool-down.
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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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Head Control Scale (HCS)
時間枠：Baseline, 4-week and 8-week
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The HCS served as the primary outcome measure.
It is a 5-point ordinal scale (0 = no control, 4 = complete head control) developed and validated by Thomas et al. (2019) for children with significant motor delay.
The scale grades the child's capacity to initiate, maintain, and orient the head against gravity in three standardized positions: supine, prone, and supported sitting.
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Baseline, 4-week and 8-week
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Segmental Assessment of Trunk Control (SATCo)
時間枠：Baseline, 4-week and 8-week
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The SATCo was used as the primary measure of hierarchical trunk control.
The instrument evaluates trunk control across seven sequential anatomical segments: head, upper thoracic, mid-thoracic, lower thoracic, upper lumbar, lower lumbar, and full trunk.
At each segment, the examiner provides manual stabilization immediately below the segment under test and grades three control domains: static (maintaining posture without external perturbation), active (maintaining posture during voluntary head or upper-limb movement), and reactive (maintaining posture during external perturbation).
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Baseline, 4-week and 8-week
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Functional Strength Assessment (FSA)
時間枠：Baseline, 4-week and 8-week
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The FSA, used here as a clinically pragmatic alternative, grades functional muscle recruitment during structured transitional maneuvers on a 1-5 ordinal scale.
Cervical and trunk flexor strength was assessed via the pull-to-sit maneuver, examining the child's ability to actively flex the head and trunk against the examiner's slow upward traction.
Cervical and trunk extensor strength was assessed via prone suspension over the therapist's lap, examining the child's ability to extend the head and upper trunk against gravity from a supported prone position.
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Baseline, 4-week and 8-week
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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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Gross Motor Function Measure-66
時間枠：Baseline, 4-week and 8-week
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The Gross Motor Function Measure-66 (GMFM-66) is a criterion-referenced, Rasch-modelled instrument designed to evaluate change in gross motor function in children with cerebral palsy.
For children at GMFCS levels IV and V, the Item Set-1 short form, derived from the full 66-item scale to reduce respondent burden while preserving measurement properties for severe phenotypes, was used in this trial.
Scores are expressed on a 0-100 interval scale, with higher values indicating greater motor capacity.
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Baseline, 4-week and 8-week
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Caregiver Priorities and Child Health Index of Life with Disabilities
時間枠：Baseline, 4-week and 8-week
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The Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD) is a parent-completed, condition-specific, multidimensional measure of health-related quality of life developed and validated specifically for children with severe non-ambulant cerebral palsy.
The instrument covers six domains-activities of daily living/personal care, positioning/transferring/mobility, comfort and emotions, communication and social interaction, health, and overall quality of life-and yields a transformed total score ranging from 0 to 100, with higher scores reflecting better caregiver-reported function and quality of life.
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Baseline, 4-week and 8-week
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出版物と役立つリンク
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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 (実際)
2025年5月1日
一次修了 (実際)
2025年12月31日
研究の完了 (実際)
2026年5月1日
試験登録日
最初に提出
2026年5月18日
QC基準を満たした最初の提出物
2026年5月24日
最初の投稿 (実際)
2026年5月29日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月29日
QC基準を満たした最後の更新が送信されました
2026年5月24日
最終確認日
2026年5月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。