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- Ensaio Clínico NCT07785011
Effect of Sensory Integration on Gross and Balance on Children With Down Syndrome
Effect of Sensory Integration on Gross Motor Function and Balance in Children With Down Syndrome
To investigate the effect of sensory integration on gross motor function in children with Down syndrome.
To investigate the effect of sensory integration on balance in children with Down syndrome.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This study will be delimited to:
- sixety children with Down syndrome, ranging in age from3 to 5 years.
- Children will be divided randomly into two groups of equal number: Control group (Group A) will receive designed physical therapy program and study group (Group B) will receive the same designed physical therapy exercises in addition to sensory integration program.
- All children will be assessed by Gross Motor Function Measure Scale (GMFM-88) and HUMAC balance system before and after the intervention.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: raheel sanad, doctoral
- Número de telefone: 01018263304
- E-mail: raheelsanad90@gmail.com
Locais de estudo
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Cairo, Egito, 02
- Recrutamento
- Abo EL resh hospital
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Contato:
- raheel sanad, master
- Número de telefone: 01018263304
- E-mail: raheelsanad90@gmail.com
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- All children diagnosed as Down syndrome, according to genetic lab reports.
- Their age ranges from 3to 5 years.
- Both genders will be included.
- They are able to stand alone.
- They are able to follow instructions. Their IQ ranges from 65 to 80, according to Stanford Binet Intelligence Scale).
- They had been referred by sensory integration problems (low registration and seeking behavior).
Exclusion Criteria:
Patients will be excluded from the study if they have any of the following:
- Persistent heart disease.
- Severe cognitive impairments.
- Recent surgical interference in the lower limbs.
- Obese children (BMI > 95).
- Patients with hip subluxation.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: CONTROLLED GROUP
Children in this group will receive designed physical therapy program for 60 minutes, 3 times per week for 3 months
|
Participants in the controlled group will receive a designed physical therapy program for 60 minutes,three times per week ,for 3 months. Participants in the study group will receive a designed physical therapy program for 30 minutes followed by a sensory integration program for 30 minutes,three times per week for 3 months. the designed physical therapy will include balance and strengthening exercises on the other hand sensory integration program will include different textured surfaces, vistebular stimulation |
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Experimental: STUDY GROUP
Children in this group will receive the same designed physical therapy exercises for 30 minutes and sensory program for other 30 minutes three times per week for 3 months.
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Participants in the controlled group will receive a designed physical therapy program for 60 minutes,three times per week ,for 3 months. Participants in the study group will receive a designed physical therapy program for 30 minutes followed by a sensory integration program for 30 minutes,three times per week for 3 months. the designed physical therapy will include balance and strengthening exercises on the other hand sensory integration program will include different textured surfaces, vistebular stimulation |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
balance measured by Stability Score of the Clinical Test of Sensory Interaction on Balance(CTSIB) using HUMAC Balance system
Prazo: 3 monthes
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balance will be assessed by the results of stability score of the Clinical Test of Sensory Interaction on Balance (CTSIB ) using HUMAC Balance system the stability score will be recorded at four conditions 1_child stand on stable surface with open eye 2_child stand on stable surface with closed eye 3_ child stand on foam surface with open eye 4_ child stand on foam surface with closed eye
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3 monthes
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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gross motor function will be assessed by Gross motor function measurement-88 scale
Prazo: 3 monthes
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The motor function skills of all children in the study will be measured by Gross Motor Function Measurement-88 scale which is a criterion based observational measure.
Standing and walking dimensions only will be selected to be tested
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3 monthes
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Raheel _SI_2025
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Participations who meet the eligibility criteria will be allocated by simple randomization via sealed opaque envelopes into two matched groups by an independent person:
• Group A (control group): Children in this group will receive designed physical therapy program for 60 minutes, 3 times per week for 3 months Group B (study group): Children in this group will receive the same designed physical therapy exercises for 30 minutes and sensory program for other 30 minutes three times per week for 3 months
Prazo de Compartilhamento de IPD
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
- ANALYTIC_CODE
- CSR
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