Early Mobilization and Equinus Correction in Spastic Cerebral Palsy
Impact of Early Postoperative Mobilization on Equinus Correction in Spastic Cerebral Palsy
The aim of this study is to investigate the effect of early postoperative mobilization on the correction of equinus deformity and the improvement of motor functions following gastrotenotomy in children with spastic-type Cerebral Palsy (CP).
H1: Early postoperative mobilization combined with AFO use after gastrotenotomy in children with spastic CP has a significant effect on equinus correction and motor function improvement.
H0: Early postoperative mobilization combined with AFO use after gastrotenotomy in children with spastic CP has no significant effect on equinus correction or motor function improvement.
The study is designed as a prospective, comparative clinical investigation. Children aged 4-14 years with spastic-type CP and Gross Motor Function Classification System (GMFCS) levels I-II will be included. Participants will be randomly assigned into two groups:
Group 1: A cast will be applied for 3 weeks postoperatively, followed by 24-hour AFO use for 3 weeks, and thereafter night-time use only. A rehabilitation program will be initiated for 12 weeks postoperatively, twice per week.
Group 2: AFO will be used 24 hours a day for 6 weeks postoperatively, followed by night-time use only. Early postoperative rehabilitation will be provided twice per week for 12 weeks.
Assessments will be conducted preoperatively and at postoperative months 3, 6, and 12. The Gross Motor Function Measure-88 (GMFM-88) and the Edinburgh Visual Gait Score will be used as measurement tools.
Gastrotenotomy is a commonly preferred surgical technique in children with spastic CP; however, there is no consensus regarding the optimal duration of postoperative immobilization or the appropriate timing of mobilization. Early mobilization has been reported to have beneficial effects on muscle-tendon flexibility, joint range of motion, and gait pattern.
The findings of this study are expected to contribute to the evidence-based standardization of rehabilitation protocols following gastrotenotomy, and to provide scientific insight into the safety and effectiveness of early mobilization. The results may support clinicians in developing more functional and time-efficient postoperative rehabilitation programs.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Cerebral Palsy (CP) is a condition characterized by a permanent motor function impairment resulting from brain injury occurring before, during, or after birth. Spastic CP accounts for approximately 70-80% of all cases, and equinus deformity is the most common deformity in the lower extremities due to increased muscle tone. Equinus deformity leads to limited ankle dorsiflexion and gait abnormalities, thereby negatively affecting functional independence. Gastrotenotomy is frequently performed in the surgical management of this deformity; however, there is no consensus in the literature regarding the duration of postoperative immobilization, AFO-use protocols, or the optimal timing of mobilization.
Early postoperative mobilization is suggested to support the remodeling of the muscle-tendon unit, increase joint range of motion, and prevent muscle shortening and contracture development. Nevertheless, controlled studies investigating the effect of early mobilization on equinus correction following gastrotenotomy in children with CP are highly limited. Therefore, the aim of this study is to evaluate the effects of early postoperative mobilization on equinus deformity correction and gross motor function improvement in children with spastic-type CP. The results are expected to contribute to the standardization of postoperative rehabilitation protocols and to support evidence-based decision-making in clinical practice.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria
- Diagnosis: Children diagnosed with spastic-type Cerebral Palsy (CP).
- Age Range: Participants aged between 4 and 14 years.
- Functional Level: Children with Gross Motor Function Classification System (GMFCS) levels I-II (able to walk independently or with minimal assistance).
- Surgical Indication: Scheduled for orthopedic surgery (gastrotenotomy) due to equinus deformity.
- Cognitive Status: Sufficient cognitive capacity to understand verbal instructions.
- Parental Consent: Written informed consent obtained from parents or legal guardians.
Exclusion Criteria
- Other CP Types: Children diagnosed with dyskinetic, ataxic, or mixed-type CP.
- Functional Level: Participants with GMFCS levels III, IV, or V (unable to walk independently or dependent on a wheelchair).
- Concomitant Orthopedic Problems: Presence of hip dysplasia, scoliosis, or severe lower extremity contractures that may affect gait patterns.
- Neuromuscular or Other Diseases: Presence of non-CP neuromuscular disorders (e.g., muscular dystrophy, peripheral neuropathy).
- Previous Surgery: History of tendon lengthening or muscle release surgery in the same lower extremity.
- Postoperative Complications: Development of surgical site infection, excessive pain, or conditions requiring reoperation.
- Noncompliance with Rehabilitation: Inability to attend prescribed physical therapy and rehabilitation sessions regularly or poor adherence to the treatment program.
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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Aktivní komparátor: Group 1 (Cast Group)
Group 1 (Cast Group): A cast will be applied for 3 weeks postoperatively, followed by 24-hour AFO use for 3 weeks, and thereafter only night-time use will be maintained.
A physiotherapist-supervised physical therapy and rehabilitation program will be initiated twice weekly for 12 weeks postoperatively.
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All participants meeting the inclusion criteria will undergo gastrotenotomy performed by a pediatric orthopedic surgeon.
Both groups will begin a physiotherapist-supervised physical therapy and rehabilitation program twice weekly for 12 weeks postoperatively.
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Aktivní komparátor: Group 2 (AFO Group)
AFO will be used 24 hours a day for 6 weeks postoperatively, followed by night-time use only.
A physiotherapist-supervised physical therapy and rehabilitation program will be initiated twice weekly for 12 weeks postoperatively.
|
All participants meeting the inclusion criteria will undergo gastrotenotomy performed by a pediatric orthopedic surgeon.
Both groups will begin a physiotherapist-supervised physical therapy and rehabilitation program twice weekly for 12 weeks postoperatively.
Group 1 (Cast Group): A cast will be applied for 3 weeks postoperatively, followed by Group 2 (AFO Group): AFO will be used 24 hours a day for 6 weeks postoperatively, followed by night-time use only.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Gross Motor Function Measure-88 (GMFM-88)
Časové okno: 4 TIMES: preoperative; postoperative 3. month; 6. month; 12. month
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The Gross Motor Function Measure-88 (GMFM-88) is a standardized, criterion-referenced observational assessment tool designed to evaluate changes in gross motor function in children with motor impairments, particularly those with Cerebral Palsy. The instrument consists of 88 items distributed across five dimensions: (A) lying and rolling, (B) sitting, (C) crawling and kneeling, (D) standing, and (E) walking, running, and jumping. Each item is scored on a 4-point ordinal scale based on the child's ability to initiate, partially perform, or fully complete the task. The GMFM-88 is widely recognized for its sensitivity to clinically meaningful changes in motor performance and is frequently used in both research and clinical settings to monitor functional progress, evaluate treatment outcomes, and compare motor capacities across time. |
4 TIMES: preoperative; postoperative 3. month; 6. month; 12. month
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Edinburgh Visual Gait Score (EVGS)
Časové okno: 4 TIMES: preoperative; postoperative 3. month; 6. month; 12. month
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The Edinburgh Visual Gait Score (EVGS) is a clinical tool used to assess gait abnormalities in children with cerebral palsy.
It provides a quantitative evaluation of 17 kinematic parameters of both lower limbs, scored based on video recordings of the child walking.
Each parameter is rated on an ordinal scale, allowing clinicians and researchers to objectively monitor gait deviations, evaluate treatment outcomes, and track changes over time.
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4 TIMES: preoperative; postoperative 3. month; 6. month; 12. month
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
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
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