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The Effect of Telerehabilitation on the Children With Cerebral Palsy and Their Caregivers

6 de junho de 2021 atualizado por: Marmara University

The Effect of Telerehabilitation on the Quality of Life, Anxiety and Depression Levels of Children With Cerebral Palsy and Their Caregivers

Cerebral palsy develops due to brain damage before, during and after birth. Motor control is impaired in individuals with cerebral palsy. Disturbances occur in muscle tone, mobility and body posture. There is no definitive treatment for cerebral palsy, but improvement in functions can be achieved with physiotherapy.

Because of the covid-19 pandemic precautions, activity level has been decreasing in children with cerebral palsy, as in adults.

Children experience physical, social and psychological problems caused by physical inactivity.

Exercises and games that can be done comfortably in the house will positively affect the physical development of children and enable them to spend productive time by getting away from excessive technology, internet and smart phone usage, excessive screen time.

The aim of this project; To ensure that children with cerebral palsy who need intense exercise and activity and who experience physical inactivity due to COVID-19 can exercise with telerehabilitation and to determine the effect of telerehabilitation on the quality of life, anxiety and depression levels of children with cerebral palsy and their caregivers.

It will be compared to a control group that did not accept telerehabilitation but was recommended to exercise at home.

Visão geral do estudo

Status

Inscrevendo-se por convite

Condições

Descrição detalhada

Cerebral palsy (SP); It is a group of permanent neuromotor disorders affecting movement, muscle tone and posture development as a result of non-progressive damage to the brain in the prenatal and neonatal period. In children with CP, it is observed that primitive reflexes continue, correction reactions occur late, muscle weakness, spasticity, loss of coordination and normal motor control cannot develop. Clinically SP; Spastic, dyskinetic, ataxic and mixed types are divided into four groups as SP.

Although there is no definitive treatment for CP, physiotherapy applications are of great importance in the treatment of problems. With physical therapy exercises, it is known that children with CP progress in factors such as postural control, muscle strength, flexibility, balance, physical activity capacity, mental well-being, participation in social life.

The COVID-19 (coronavirus) pandemic, which has recently surrounded the whole world, has caused serious measures to be taken in all areas in our country. Serious warnings are made that everyone should stay at home. During this period, physical activity levels of children as well as adults decreased significantly. Children experience physical, social and psychological problems caused by physical inactivity.

Exercises and games that can be done easily in the house will positively affect the physical development of children and enable them to spend productive time by getting away from excessive technology, internet and smart phone usage, excessive screen time. (aerobic) and stretching activities. Physical activity programs that are age-appropriate, fun and diverse should be created for children.

In addition, games for physical activity in the family; It is also thought that it will increase socialization within the family, that individuals will listen to each other more, understand, share more, and prevent some anxiety and stress caused by coronavirus.

The aim of this project; To ensure that children with cerebral palsy who need intense exercise and activity and who experience physical inactivity due to COVID-19 can exercise with telerehabilitation and to determine the effect of telerehabilitation on the quality of life, anxiety and depression levels of children with cerebral palsy and their caregivers. It will be compared to a control group that did not accept telerehabilitation but was recommended to exercise at home.

Tipo de estudo

Intervencional

Inscrição (Antecipado)

34

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

      • Istanbul, Peru, 34890
        • Marmara University School of Medicine Department of Physical Medicine and Rehabilitation

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

6 anos a 18 anos (Filho, Adulto)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

Diagnosis of Spastic Hemiplegic and Diplegic Cerebral Palsy in participating children confirmed by pediatric neurologists

Being GMFCS I and II

Spasticity value of 1, 2 or maximum 3 in the evaluation made with Modified Ashworth Scale (MAS) on lower extremity muscles

Being able to stand and walk without using any auxiliary equipment

Being mentally capable of reading the commands of the assessment.

Agree to participate in the study

Exclusion Criteria:

Not having ambulation

Having a cognitive disorder

Having undergone any orthopedic surgery or spasticity replacement procedure in the past 12 months

Having vision problems except refraction

Having any known systemic problems

Having an uncontrolled epileptic seizure

Having lower extremity contracture that affects the evaluation

The occurrence of any health problems that could affect the work

Refusing to participate in the study

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Cuidados de suporte
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: telerehabilitation
The exercises will be applied twice a week for a total of 12 weeks, and each program will last roughly 30 minutes.
The exercise program will begin with a warm-up, followed by a stretching exercise and an alphabetical exercise game called what's your name, and will end with a cool-down. The exercises will be performed 2 times a week for a total of 12 weeks, and each program will last for roughly 30 minutes. it will last. In what is your name game, 10 5-letter words containing the whole alphabet were produced and children will work out the exercises corresponding to each letter with a word they choose for each day.
Comparador Ativo: control
The same exercise program will be prepared and given as a printout and they will be asked to do their exercises at home. This group will also be included in the study as a control group.
The same exercise program will be prepared and given to the patients who are offered and not accepted telerehabilitation, and they will be asked to do their own exercises at home. This group will also be included in the study as a control group.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
CP-QOL-Child ve Teen
Prazo: Day 0 - Day 90
Evaluates the quality of life in Cerebral Palsy.
Day 0 - Day 90
Revised Child Anxiety and Depression Scale
Prazo: Day 0 - Day 90
It was developed to screen for anxiety disorders and depression.
Day 0 - Day 90
STAI-State Trait Anxiety Inventory
Prazo: Day 0 - Day 90
It is a self-evaluation questionnaire consisting of short statements.
Day 0 - Day 90
BECK Depression Inventory
Prazo: Day 0 - Day 90
It will be applied in determining depression levels.
Day 0 - Day 90

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

  • Cadeira de estudo: Evrim Karadag-Saygi, Prof. Dr., Physical Medicine and Rehabilitation Department, School of Medicine, Marmara University, Istanbul
  • Investigador principal: Ayca Evkaya Acar, Lecturer, Physiotherapy and Rehabilitation, Faculty of Health Sciences, Istanbul Medeniyet University
  • Investigador principal: Nurahsen Demir, Res. Asst., Physical Medicine and Rehabilitation Department, School of Medicine, Marmara University, Istanbul

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

16 de fevereiro de 2021

Conclusão Primária (Antecipado)

12 de junho de 2021

Conclusão do estudo (Antecipado)

26 de junho de 2021

Datas de inscrição no estudo

Enviado pela primeira vez

6 de junho de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

6 de junho de 2021

Primeira postagem (Real)

11 de junho de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

11 de junho de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

6 de junho de 2021

Última verificação

1 de junho de 2021

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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 .

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