- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07568808
Core Stabilization and Kinesthetic Training in Diplegic CP
Comparative Effects of Core Stabilization Exercises and Kinesthetic Training in Diplegic Cerebral Palsy
This randomized controlled trial aimed to compare the effects of core stabilization exercises (CSE) and kinesthetic training (KT) on postural control in children with spastic diplegic cerebral palsy (GMFCS Level III), aged 4-8 years. Cerebral palsy was recognized as a non-progressive neurological disorder that affects movement, posture, and motor function, often leading to impaired balance, reduced trunk control, and decreased functional independence. Postural instability was identified as a key concern in diplegic CP, and effective rehabilitation strategies were considered essential to improve mobility and daily functioning. Core stabilization exercises focused on strengthening deep trunk muscles to enhance stability and alignment, whereas kinesthetic training emphasized proprioceptive awareness and neuromuscular coordination to improve movement accuracy and balance. Although both interventions had shown benefits individually, their comparative effectiveness remained unclear.
A total of 32 participants were recruited using purposive sampling and were randomly assigned into two groups: CSE (n=16) and KT (n=16). Both groups received conventional physiotherapy for 15 minutes followed by 30 minutes of their respective interventions, three times per week for 12 weeks. Outcome assessment was conducted at baseline, mid-intervention (6 weeks), and post-intervention (12 weeks) using the Pediatric Berg Balance Scale (PBBS) to evaluate static and dynamic balance. Data were analyzed using SPSS, applying paired t-tests for within-group comparisons and independent t-tests for between-group analysis, with significance set at p < 0.05. This study aimed to determine the more effective intervention for improving balance and functional outcomes, thereby supporting evidence-based clinical practice in pediatric rehabilitation.
A total of 32 participants will be recruited using purposive sampling and randomly assigned into two groups: CSE (n=16) and KT (n=16). Both groups will receive conventional physiotherapy for 15 minutes followed by 30 minutes of their respective interventions, three times per week for 12 weeks. Outcome assessment will be conducted at baseline, mid-intervention (6 weeks), and post-intervention (12 weeks) using the Pediatric Berg Balance Scale (PBBS) to evaluate static and dynamic balance. Data will be analyzed using SPSS, applying paired t-tests for within-group comparisons and independent t-tests for between-group analysis, with significance set at p < 0.05. This study aims to determine the more effective intervention for improving balance and functional outcomes, thereby supporting evidence-based clinical practice in pediatric rehabilitation.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
This randomized controlled trial was conducted to compare the effects of core stabilization exercises (CSE) and kinesthetic training (KT) on postural control in children diagnosed with spastic diplegic cerebral palsy classified at Gross Motor Function Classification System (GMFCS) Level III, aged between 4 and 8 years. Children within this classification typically demonstrated limitations in independent mobility and required assistive devices for ambulation, with notable impairments in trunk control and balance.
Postural instability in this population was identified as a major contributor to functional limitations, affecting activities such as sitting, standing, and transitional movements. Impaired trunk stability and reduced proprioceptive input were considered key factors influencing balance deficits. Therefore, targeted interventions focusing on trunk control and sensory-motor integration were explored to enhance postural regulation and functional independence.
Core stabilization exercises were implemented with the aim of improving activation, strength, and endurance of deep trunk musculature, including the transversus abdominis, multifidus, and pelvic stabilizers. These exercises emphasized controlled movements, alignment, and postural symmetry in various positions such as supine, sitting, and supported standing. Progression was based on the child's ability to maintain stability with reduced external support.
Kinesthetic training was designed to enhance proprioceptive awareness, joint position sense, and neuromuscular coordination. Activities included weight-shifting, balance challenges on stable and unstable surfaces, guided movement tasks, and functional reaching exercises. The intervention focused on improving the child's ability to perceive and adjust body position in space, thereby facilitating better motor control and balance responses.
Participants were recruited through purposive sampling from pediatric rehabilitation settings and were randomly allocated into two intervention groups using a simple randomization method. Each group consisted of 16 participants. Both groups received a standardized conventional physiotherapy program to ensure consistency in baseline care. This included stretching of spastic muscle groups, range-of-motion exercises, and facilitation of functional movements.
Following conventional therapy, participants underwent their assigned intervention (CSE or KT) for 30 minutes per session. The intervention was delivered three times per week over a period of 12 weeks. Sessions were supervised by trained physiotherapists to ensure adherence, safety, and appropriate progression of exercises.
Outcome measures were recorded at three time points: baseline (prior to intervention), mid-intervention (6 weeks), and post-intervention (12 weeks). Postural control and balance were assessed using the Pediatric Berg Balance Scale (PBBS), a validated tool for measuring both static and dynamic balance in pediatric populations. The scale included functional tasks such as sitting, standing, reaching, turning, and transferring, with scores reflecting the child's level of independence and stability.
Data were analyzed using statistical software. Within-group comparisons were performed to assess changes over time, while between-group comparisons were conducted to determine differences in effectiveness between the two interventions. Statistical significance was set at p < 0.05.
The findings of this study were intended to provide evidence regarding the relative effectiveness of core stabilization versus kinesthetic training in improving balance in children with spastic diplegic cerebral palsy. The results were expected to contribute to clinical decision-making and support the development of targeted rehabilitation protocols aimed at enhancing functional outcomes and quality of life in this population.
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, 42000
- Sehat Medical Complex, Pediatric Rehabilitation Department, ULTH.
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Spastic diplegic CP
- GMFCS Level III
- Age range: 4 to 8 years
- Must have verbal communication
- Ability to follow verbal commands
Exclusion Criteria:
- Severe cognitive impairment
- History of epilepsy or seizures in the past 3 months.
- Children with progressive neurological or genetic disorders (e.g., muscular dystrophy).
- Any acute respiratory infection or chronic pulmonary disease
- Any visual or auditory impairments
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: Core Stabilization Group
Participants in this group received a core stabilization exercise program focusing on deep abdominal and back muscles.
The protocol included the plank, bird-dog, and dead bug exercises, which were performed three times per week for four weeks.
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A 4-week exercise program focusing on deep abdominal and back muscles.
Sessions are 45 minutes each, 3 times per week.
Exercises include The Plank (front and side), Bird-Dog, and Dead Bug.
Progression will be managed by increasing hold times and repetitions as the patient's stability improves.
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Experimentální: Kinesthetic Training Group
Participants in this group underwent kinesthetic training aimed at improving proprioception and joint position sense.
This included weight-shifting and balance activities on stable and unstable surfaces, which were performed three times per week for four weeks.
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A 4-week sensory-motor training program designed to improve proprioception and balance.
Sessions are 45 minutes each, 3 times per week.
Activities include single-limb standing, weight shifting on stable and unstable surfaces (like foam pads), and coordinated limb movements to enhance joint position sense and postural control.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Balance Control is measured using the PBBS to evaluate both static and dynamic postural stability.
Časové okno: 6 months
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The Pediatric Berg Balance Scale (PBBS) is a standardized clinical assessment used to measure functional balance and postural control in children with motor challenges.
It consists of 14 distinct tasks that mimic activities of daily living, including the ability to sit and stand without support, transfer between chairs, reach forward, and pick up objects from the floor.
Each task is evaluated on a 5-point scale ranging from 0 to 4, where a higher score reflects a greater level of independence and stability.
With a maximum total score of 56, the PBBS serves as a reliable tool for tracking a child's progress over time and determining the effectiveness of therapeutic interventions.
In this clinical trial, the scale is utilized at baseline, week 6, and week 12 to provide a clear quantitative record of the participant's balance improvements.
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6 months
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Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- Eliasson, A. C., Krumlinde-Sundholm, L., Rösblad, B., Beckung, E., Arner, M., Ohrvall, A. M., & Rosenbaum, P. (2006). The Manual Ability Classification System (MACS) for children with cerebral palsy: scale development and evidence of validity and reliability. Dev Med Child Neurol, 48(7), 549-554.
- Akay, T., & Murray, A. J. (2021). Relative contribution of proprioceptive and vestibular sensory systems to locomotion: opportunities for discovery in the age of molecular science. International Journal of Molecular Sciences, 22(3), 1467.
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
- UOL/IREB/25/12/0035.
Plán pro data jednotlivých účastníků (IPD)
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Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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