- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07613515
Core Strength for Head Control and Quality of Life in Cerebral Palsy
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.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Jeddah, 사우디 아라비아
- Faculty of Medical Rehabilitation Sciences
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Head Control Scale (HCS)
기간: 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)
기간: 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)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Gross Motor Function Measure-66
기간: 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
기간: 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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공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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