- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07764952
Effects of Core Stability Program on Abdominal Endurance in Wheelchair Bound Cerebral Palsy
Effects of Core Stability Program on Abdominal Endurance and Constipation in Wheelchair Bound Children With Cerebral Palsy
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Although core stability training has been extensively explored in children with cerebral palsy (CP), particularly for improving trunk control, balance, and overall gross motor function, there remains a notable gap in the literature regarding its effects on abdominal endurance and gastrointestinal outcomes such as constipation. Most of the available research has primarily focused on ambulatory children with CP, often overlooking those who are wheelchair-bound and typically present with more severe functional limitations. This creates an important gap, as non-ambulatory children may have different rehabilitation needs and may respond differently to therapeutic interventions.
While the positive influence of core stability exercises on postural control and functional mobility is well established, their potential role in enhancing abdominal muscle endurance has not been thoroughly investigated. Abdominal endurance is particularly important in this population, as weak core musculature can contribute not only to poor posture but also to reduced intra-abdominal pressure, which may adversely affect bowel function. Constipation is a common and often chronic issue among children with CP, especially those who are wheelchair-dependent, due to factors such as limited mobility, reduced muscle tone, and impaired neuromuscular coordination.
Existing research addressing constipation in children with CP has largely concentrated on pharmacological treatments and dietary modifications, with comparatively little emphasis on physiotherapy-based interventions. This highlights a missed opportunity to explore non-invasive, exercise-based strategies that could potentially address both musculoskeletal and gastrointestinal concerns simultaneously. To date, very few comprehensive studies have examined the combined effects of core stability training on both abdominal endurance and constipation severity in non-ambulatory children with CP. Therefore, this study aims to address this critical gap by investigating whether a structured core stability program can improve abdominal muscle endurance while also reducing constipation severity, ultimately contributing to better functional health 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, 54000
- CLC
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Diagnosis of cerebral palsy - particularly spastic or hemiplegic types
- Regardless the cause of CP
- Age range typically 6-12 years old
- A motor function level IV as per the Gross Motor Function Classification System
- Grade 1 / 1+ (mild spasticity) according to Modified Ashworth Scale (MAS)
- Non-ambulatory or inability to ambulate
- CP children with constipation ; Fewer than 3 defecations per week, History of hard stools or painful defecation
- Defecation frequency measured less than three times a week is considered constipation using Rome IV
- Parental/guardian permission (informed consent) and child assent of a minor if the patient was able to assent (35).
- The ability to understand and follow instructions
Exclusion Criteria:
- Had visual impairments, extreme spasticity, uncontrolled convulsions, any other neuromuscular diseases, ataxia-telangiectasia, spinocerebellar ataxia, and/or Joubert syndrome
- Children who received botulinum toxin injection within the last six months, had fixed contractures or deformities of the spine or the extremities, and had previous surgeries of the spine or the lower extremities within one year or visual, auditary or respiratory disorders
- Children with any other systemic co morbidities, physical deformity in GIT, intellectual disability and recent traumatic brain injury
- Participation in other intensive physical therapy programs simultaneously
- Severe musculoskeletal deformities that limit participation in the training
- Children with congenital anatomic abnormalities of the urogenital area, including Hirschsprung's disease, spina bifida, anorectal malformations, urethral strictures, down syndrome or hypothyroidism, gastrointestinal bleeding, intestinal perforation, ileus obstruction, inflammatory bowel disease, toxic megacolon, metal implants or pacemakers in the abdominal area, open wounds in the abdominal and thoracic region, history of surgery on the stomach, malignancy .
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Core Stability Program
Participants in this arm will receive a structured core stability training program designed to improve abdominal muscle strength and endurance.
The program will include supervised therapeutic exercises focusing on trunk control, core activation, and postural stability, administered over a specified period in addition to routine care or standard management.
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The intervention consists of a structured core stability program designed to improve trunk control and abdominal muscle function in wheelchair-bound children with cerebral palsy.
The program includes targeted exercises focusing on strengthening deep abdominal and trunk muscles through progressive, age-appropriate, and functional activities performed under physiotherapist supervision over a defined period.
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Experimentální: traditional Physiotherapy
Participants in this arm will receive conventional physiotherapy focusing on improving abdominal endurance.
The intervention will include exercises such as static and dynamic trunk strengthening, pelvic tilts, assisted sit-ups, breathing exercises, and postural control activities.
Sessions will be conducted under the supervision of a trained physiotherapist, typically 3-5 times per week for a specified duration.
The program aims to enhance core muscle strength, improve trunk stability, and support functional activities in wheelchair-bound children with cerebral palsy.
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Participants in this arm will receive conventional physiotherapy focusing on improving abdominal endurance.
The intervention will include exercises such as static and dynamic trunk strengthening, pelvic tilts, assisted sit-ups, breathing exercises, and postural control activities.
Sessions will be conducted under the supervision of a trained physiotherapist, typically 3-5 times per week for a specified duration.
The program aims to enhance core muscle strength, improve trunk stability, and support functional activities in wheelchair-bound children with cerebral palsy.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Abdominal Muscle Endurance
Časové okno: 3 months
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Abdominal muscle endurance will be assessed to evaluate the effect of a core stability program in wheelchair-bound children with cerebral palsy. The Modified Curl-Up Test will be used. Participants perform as many correct curl-ups as possible in 1 minute with standardized form and positioning. Time Frame: Baseline and 3 months Measurement: Number of correctly performed curl-ups in 1 minute. Higher number indicates better outcome. |
3 months
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Change in Constipation Severity
Časové okno: 3 months
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Constipation severity will be assessed to evaluate the effect of a core stability program on bowel function in wheelchair-bound children with cerebral palsy. The Modified Bristol Stool Form Scale for Children [mBSFS-C] will be used. Parents/caregivers record stool type daily for 7 days. An average weekly score will be calculated. Time Frame: Baseline and 3 months Measurement: mBSFS-C score ranging from 1 to 7. Scores of 1-2 indicate constipation. Scores of 3-4 indicate normal stool form. Improvement toward scores of 3-4 indicates better outcome. |
3 months
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Javeria Azeem, MS PPT, Riphah International University
Publikace a užitečné odkazy
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
- RCR/RCR&AHS/25/0747
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