- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07692087
Effect of Intensive Segmental Trunk Training on Upper Extremity Function and Seated Postural Stability in Children With Spastic Diplegic Cerebral Palsy
Effect of Intensive Segmental Trunk Training on Upper Extremity Function and Seated Postural Stability in Children With Spastic Diplegic Cerebral Palsy: A Randomized Controlled Trial
The goal of this randomized controlled trial is to evaluate whether intensive segmental trunk training (ISTT) can improve upper extremity function and seated postural stability in children aged 4-12 years with spastic diplegic cerebral palsy and moderate trunk control impairments. The main questions it aims to answer are:
Does intensive segmental trunk training lead to greater improvements in seated postural stability compared to standard physical therapy? Does intensive segmental trunk training lead to greater improvements in upper extremity function compared to standard physical therapy? Researchers compared the ISTT group to the control group (standard physical therapy) to see if the targeted trunk training produces significantly better outcomes in trunk control, upper extremity skills, and gross motor function.
Participants underwent their assigned training regimen five times per week for eight weeks and complete pre- and post-intervention assessments measuring trunk control (SATCo, TCT), upper extremity function (QUEST, Box and Block Test), and gross motor function (GMFM).
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
This single-blind randomized controlled trial investigated the efficacy of intensive segmental trunk training (ISTT) as a targeted intervention for improving seated postural control and upper limb function in children with spastic diplegic cerebral palsy (CP). Trunk control deficits are a hallmark impairment in this population, contributing to compromised upper extremity function, reduced seated stability, and limitations in activities of daily living. While conventional physical therapy often addresses trunk control indirectly, this study evaluated whether a structured, segment-specific approach yields superior outcomes.
Thirty children aged 4-12 years with spastic diplegic CP and Gross Motor Function Classification System (GMFCS) levels I-III were recruited from outpatient neurorehabilitation center. Inclusion required moderate trunk control impairment, defined as a score of ≤ 3 on the Trunk Control Test (TCT) item assessing sitting without arm support. Children with uncontrolled seizures, Botulinum toxin injections within the preceding six months, orthopedic surgery within the past year, or cognitive impairment that would preclude task comprehension were excluded.
Participants were randomly assigned to either the ISTT group (n = 15) or the control group (n = 15) using a sealed envelope method with concealed allocation. The ISTT group received specialized training targeting segmental trunk control at the thoracic, lumbar, and pelvic levels. Training sessions, conducted five times weekly for eight weeks (40 sessions total, 45 minutes each), incorporated graded exercises progressing from static to dynamic sitting balance. Key ISTT components included pelvic tilt facilitation, isolated thoracic and lumbar segmental mobilization during weight shifting, trunk rotation with reaching tasks, and perturbation-based reactive balance training using a tilt board. Exercises were progressively advanced based on individual tolerance and performance.
The control group received standard physical therapy of equal duration and frequency, emphasizing neurodevelopmental treatment (NDT) principles, passive stretching of lower extremity muscles, strengthening of the lower limbs, and gait training.
Outcome measures were assessed at baseline, immediately post-intervention (week 8), and at a four-week follow-up. The primary outcomes were seated postural stability, measured by the Segmental Assessment of Trunk Control (SATCo) and the Trunk Control Test (TCT). Secondary outcomes included upper extremity function, assessed via the Quality of Upper Extremity Skills Test (QUEST) and the Box and Block Test (BBT), and gross motor function, measured by the Gross Motor Function Measure (GMFM-88). All assessments were performed by a blinded pediatric physical therapist.
A priori sample size calculation was performed based on pilot data with an effect size of 0.6, alpha of 0.05, and power of 0.80, yielding a minimum of 13 participants per group. Between-group differences were analyzed using repeated measures ANOVA, with post-hoc Bonferroni corrections. Within-group pre-post comparisons used paired t-tests. Effect sizes were calculated using Cohen's d.
The study was approved by the institutional ethics committee. Written informed consent was obtained from parents or legal guardians.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Punjab Province
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Lahore, Punjab Province, Pákistán
- Pediatric Physical Therapy and Neurorehabilitation Department at the University of Lahore Teaching Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
Participants included were aged 4-12 years, classified under Gross Motor Function Classification System (GMFCS) Levels II-IV, with ability to sit independently for at least 10 seconds and follow simple verbal instructions. Children with trunk control scores within a moderate impairment range on the Trunk Control Test (TCT) and Segmental Assessment of Trunk Control (SATCo) were included. Parental consent was obtained prior to participation.
Exclusion Criteria:
Children with cognitive impairments severe enough to limit task comprehension, uncontrolled seizures, history of surgical interventions or Botulinum toxin injections in the preceding 6 months, and those receiving other therapeutic interventions targeting trunk control or upper limb function concurrently were excluded.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Intensive Segmental Trunk Training (ISTT) Group
Participants received specialized segmental trunk training targeting the thoracic, lumbar, and pelvic levels, five times per week for eight weeks (40 sessions, 45 minutes each).
Exercises progressed from static to dynamic seated balance and included pelvic tilt facilitation, isolated segmental mobilization during weight shifting, trunk rotation with reaching tasks, and perturbation-based reactive balance training using a tilt board.
|
A structured, progressive training program targeting segmental trunk control at the thoracic, lumbar, and pelvic levels.
Conducted five times per week for eight weeks (40 sessions, 45 minutes each).
Exercises progress from static to dynamic seated balance and include pelvic tilt facilitation, isolated segmental mobilization during weight shifting, trunk rotation with reaching tasks, and perturbation-based reactive balance training using a tilt board.
Difficulty is advanced based on individual tolerance and performance.
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Aktivní komparátor: Control Group (Standard Physical Therapy)
Participants received standard physical therapy of equal duration and frequency (five times per week for eight weeks, 45 minutes per session), emphasizing neurodevelopmental treatment (NDT) principles, passive stretching of lower extremity muscles, lower limb strengthening, and gait training.
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Conventional physical therapy based on neurodevelopmental treatment (NDT) principles, involving passive stretching of lower extremity muscles, lower limb strengthening, and gait training.
Delivered at the same frequency and duration as the experimental intervention (five times per week, 45 minutes per session, for eight weeks).
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Segmental Assessment of Trunk Control (SATCo) - change in seated postural stability
Časové okno: Baseline, immediately post-intervention (Week 8)
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A reliable and valid measure that assesses segmental trunk control at cervical, thoracic, and lumbar levels in sitting.
Scores range from 0 (no trunk control) to 20 (full segmental trunk control), with higher scores indicating better seated postural stability.
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Baseline, immediately post-intervention (Week 8)
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Trunk Control Test (TCT) - change in trunk control
Časové okno: Baseline, immediately post-intervention (Week 8)
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A standardized test evaluating trunk control ability.
Higher scores indicate better trunk control function.
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Baseline, immediately post-intervention (Week 8)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Quality of Upper Extremity Skills Test (QUEST) - Change in upper extremity function
Časové okno: Baseline, immediately post-intervention (Week 8)
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Assesses dissociated movements, grasp, protective extension, and weight bearing in the upper extremities.
Scores are expressed as a percentage (0-100%), with higher scores indicating better upper extremity function.
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Baseline, immediately post-intervention (Week 8)
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Box and Block Test (BBT) - Change in manual dexterity
Časové okno: Baseline, immediately post-intervention (Week 8)
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Measures unilateral manual dexterity by counting the number of blocks transferred from one compartment to another within 60 seconds.
Higher scores indicate better manual dexterity.
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Baseline, immediately post-intervention (Week 8)
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Gross Motor Function Measure (GMFM-88) - Change in gross motor function
Časové okno: Baseline, immediately post-intervention (Week 8)
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A standardized observational measure assessing gross motor function across five dimensions (lying/rolling, sitting, crawling/kneeling, standing, walking/running/jumping).
Scores range from 0 to 100%, with higher scores indicating better gross motor function.
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Baseline, immediately post-intervention (Week 8)
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
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- PROTOKOL STUDY
- ICF
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