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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: 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.
|
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.
|
|
Comparador Ativo: 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.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Gross Motor Function Measure-88 (GMFM-88)
Prazo: 4 TIMES: preoperative; postoperative 3. month; 6. month; 12. month
|
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
|
|
Edinburgh Visual Gait Score (EVGS)
Prazo: 4 TIMES: preoperative; postoperative 3. month; 6. month; 12. month
|
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.
|
4 TIMES: preoperative; postoperative 3. month; 6. month; 12. month
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- AkyurekE5
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Paralisia cerebral
-
Ankara City Hospital BilkentRecrutamentoParalisia Cerebral (PC) | Paralisia Cerebral, Espástica, Diplégica | Paralisia Cerebral Diplégica com Espasticidade | Estimulação Magnética TranscranianaTurquia (Türkiye)
-
Suleyman Demirel UniversityConcluídoParalisia cerebral | Paralisia Cerebral Hemiplégica | Paralisia Cerebral Diplegia EspásticaTurquia (Türkiye)
-
Holland Bloorview Kids Rehabilitation HospitalCanadian Institutes of Health Research (CIHR)RecrutamentoParalisia Cerebral (PC) | Paralisia Cerebral HemiplégicaCanadá
-
University of Colorado, DenverConcluídoFluxo Sanguíneo Cerebral | Função cerebralEstados Unidos
-
Cairo UniversityConcluídoParalisia Cerebral (PC) | Paralisia Cerebral UnilateralEgito
-
UMC UtrechtConcluídoCirculação extracorpórea | Perfusão Cerebral | Oxigenação CerebralHolanda
-
University of California, San FranciscoAinda não está recrutandoParalisia cerebral | Paralisia Cerebral (PC) | Infantil | Paralisia Cerebral InfantilEstados Unidos
-
Ankara Ataturk Sanatorium Training and Research...Ainda não está recrutandoOximetria Cerebral Intraoperatória | Monitorização da Oxigenação CerebralTurquia (Türkiye)
-
Lahore University of Biological and Applied SciencesAinda não está recrutandoParalisia Cerebral Diplegia EspásticaPaquistão
-
Maastricht University Medical CenterNational Dairy CouncilAinda não está recrutandoFluxo Sanguíneo Cerebral | Performance cognitiva | Microbiota Intestinal | Controle de apetite | Função Vascular Cerebral | Sensibilidade cerebral à insulinaHolanda
Ensaios clínicos em Gastro Tenotomy
-
Huazhong University of Science and TechnologyRecrutamentoCâncer Gástrico Inicial | Neoplasia Intraepitelial de Baixo Grau | Neoplasia Intraepitelial de Alto Grau | Neoplasia Intraepitelial GástricaChina