Continuous Passive Motion on Upper Limb Spasticity and Hand Function in Children With Hemiplegic Cerebral Palsy (CPMCP)
Effect of Continuous Passive Movement on Upper Limb Spasticity and Hand Function in Children With Hemiplegia
The goal of this clinical trial is to evaluate the effect of Continuous passive motion (CPM) on upper limb spasticity and hand function in children with hemiplegic cerebral palsy.
The main questions it aims to answer are:
Does continuous passive motion (CPM) have an effect on upper limb spasticity and hand function in children with hemiplegic cerebral palsy?
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
Cerebral palsy (CP) is a common underlying factor contributing to motor impairment in children. CP has frequently changed over the years. The most recent definition of CP is a collection of lasting irregularities in the development of movement and body positioning that result in activity restrictions for the affected person (Sadowska et al.,2020).
Hemiplegia is a neurological disorder that is frequently detected in children with CP. It may provoke altered selective motor control, weakness, and spasticity. While one side is affected by the disorder, the contralateral side appears to maintain complete functionality. The consequent asymmetry has been proven to affect many daily-life tasks, such as walking (DiNardo et al., 2019).
To date, little research examined the effect of Continuous passive motion (CPM) on functional impairment for upper extremity in CP children with hemiplegia. In addition to the economic changes in our society and increase of the cost of physical therapy session push us to investigate the immediate effect of physical therapy techniques and modalities and determine its validity in order to decrease physical therapy period and cost and improve its effectiveness.
Thus, outcomes of this study will be beneficial to determine the effect of CPM may be effective in the treatment of upper extremity in children with hemiplegia.
Statement of the problem:
Does continuous passive motion (CPM) have an effect on upper limb spasticity and hand function in children with hemiplegic cerebral palsy?
Purpose of the study:
The Purpose of the study was:
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To evaluate the effect of Continuous passive motion (CPM) on upper limb spasticity in children with hemiplegic cerebral palsy.
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To evaluate hand function in children with hemiplegic cerebral palsy. The selected subjects will be divided randomly by sealed envelopes into two groups of equal number; thirty children for each group. Participants received 1 hour and 30 minutes per day, 3 days/week for 3 month.
- Study group :
Children of this group will receive specially designed physical therapy program and occupational therapy program in addition to continuous passive movement for the affected upper limb.
-control group : Children of this group will receive only specially designed physical therapy program and occupational therapy program.
Inclusive criteria:
The subjects will be included if:
- Their age will be ranged from 9-12 years.
- They are diagnosed with hemiplegic cerebral palsy.
- The degree of spasticity; grade 2 according to modified Ashworth scale (Bohanon and Smith, 1987). (Appendix I)
- Manual ability to handle objects in daily activities will be at level III according to Manual Ability Classification System (MACS) (Eliasson et al., 2006). (Appendix II)
- They will be able to understand orders given to them.
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: Eman Fathy Mohamed, Doctoral Degree
- Número de teléfono: +201124424650
- Correo electrónico: doctoreman.fathy123@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Gehan Hassan El-Meniawy, Professor
- Número de teléfono: +201111801114
- Correo electrónico: ggelmeniawy@Gmail.com
Ubicaciones de estudio
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Giza, Egipto
- Faculty of physical therapy Dokki,Giza Egypt
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- The subjects will be included if:
- Their age will be ranged from 9 -12 years.
- They are diagnosed with hemiplegic cerebral palsy.
- The degree of spasticity; grade 2 according to modified Ashworth scale (Bohanon and Smith, 1987). (Appendix I)
- Manual ability to handle objects in daily activities will be at level III according to Manual Ability Classification System (MACS) (Eliasson et al., 2006). (Appendix II)
- They will be able to understand orders given to them.
Exclusion Criteria:
- The subjects will be excluded if they:
- fixed deformities in the spine and/or upper extremities or suffering from Seizures.
- visual nor auditory problems.
- perceptual or cognitive problems.
- injected by BOTOX in deltoid or biceps brachii muscles at the last 6 months
- have surgical interference in upper limbs and/or spine at the last year.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
|
Experimental: study group
-Study group: Children will receive specially designed physical therapy program + occupational therapy program in addition to continuous passive movement (CPM) for the affected upper limb. 1.5 hours/day, 3 days/week for 3 months. |
|
|
Comparador activo: Control group
Children will receive only the specially designed physical therapy program + occupational therapy program 1.5 hours/day, 3 days/week for 3 months. |
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Hand functions
Periodo de tiempo: 45-60 minutes
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Hand functions as manual dexterity, fine motor precision and fine motor integration will be assessed using Bruininks- Oseretsky Test of Motor Proficiency 2nd Edition |
45-60 minutes
|
Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Spasticity of upper limb
Periodo de tiempo: 10 minutes
|
Spasticity will be assessed using electromyographic apparatus (H/M ratio ) |
10 minutes
|
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strength of biceps and deltoid
Periodo de tiempo: 15 minutes
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Lafayette (hand held dynamometer) |
15 minutes
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Investigador principal: Eman Fathy Mohamed, dectoral degree, El salam university
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
Otros números de identificación del estudio
- P.T.REC/012/005697
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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