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Core Strength for Head Control and Quality of Life in Cerebral Palsy

24. maj 2026 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

38

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Saudi Arabien
      • Jeddah, Saudi Arabien
        • Faculty of Medical Rehabilitation Sciences

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: Core Strength Training
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Head Control Scale (HCS)
Tidsramme: Baseline, 4-week and 8-week
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.
Baseline, 4-week and 8-week
Segmental Assessment of Trunk Control (SATCo)
Tidsramme: Baseline, 4-week and 8-week
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).
Baseline, 4-week and 8-week
Functional Strength Assessment (FSA)
Tidsramme: Baseline, 4-week and 8-week
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.
Baseline, 4-week and 8-week

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Gross Motor Function Measure-66
Tidsramme: Baseline, 4-week and 8-week
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.
Baseline, 4-week and 8-week
Caregiver Priorities and Child Health Index of Life with Disabilities
Tidsramme: Baseline, 4-week and 8-week
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.
Baseline, 4-week and 8-week

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Cairo University

Samarbejdspartnere

King Abdulaziz University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. maj 2025

Primær færdiggørelse (Faktiske)

31. december 2025

Studieafslutning (Faktiske)

1. maj 2026

Datoer for studieregistrering

Først indsendt

18. maj 2026

Først indsendt, der opfyldte QC-kriterier

24. maj 2026

Først opslået (Faktiske)

29. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HA-02-J-008

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