- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05213715
The Effect Of Somatosensory Perceptıon And Proprıoceptıon On Upper Extremıty Functıonal Skılls (CP)
30 de marzo de 2022 actualizado por: Hatice Adiguzel, Kahramanmaras Sutcu Imam University
The Effect Of Somatosensory Perception And Proprioception On Upper Extremity Functional Skills In Children With Hemiparetic And Diparetic Cerebral Palsy
Cerebral Palsy (CP) is a non-progressive neurodevelopmental disorder characterized by posture and movement disorders as a result of damage to the immature brain for any reason before, during or after birth.In addition to tone, postural and neuromuscular control in children with Cerebral Palsy; Problems are also observed in communication skills, perceptual and cognitive systems and sensory systems.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
In neurodevelopmental theory, sensory and motor systems mutually support the development of each other.
In addition to the motor problems observed in SP; Sensory-motor impairment, which occurs with the effects of systems such as proprioception, tactile (touch), and vestibular (balance), emerges as the main problem.
With the involvement of the central nervous system (CNS) in CP, the sensory systems are also affected along with the motor systems.
The involvement of the sensory system is seen in 45% of these children and presents with a white matter lesion.
One of the important factors affecting the activities of daily living (ADL) in children with Cerebral Palsy is the deficiencies in their functions as a result of the affected upper extremity.
Deficiencies in sensory input can cause delays in learning new motor movements.
This can result in disuse of the extremities and sensitivity.
The somatosensory cortex, which is important for sensory integration; It is the area of the brain that is sensitive to tactile sensations from the body.
It is known that the somatosensory system, which carries these tactile stimuli to the somatosensory cortex, is active from the early stage of life.
Sensory and motor interactions experienced in the early stages of life are important for motor development even in the early stages.
The improvement in measurable cortical responses of the tactile system; It starts from the 8th week of intrauterine and continues until the postpartum period.
In the newborn period, the infant's responses to tactile and proprioceptive stimuli play an important role in the development of motor, cognitive, social and communication skills during infancy and early childhood.
The aim of this study is to investigate the effects of somatosensory perception and proprioception on upper extremity functional skills in children with hemiparetic and diparetic CP.
Tipo de estudio
De observación
Inscripción (Actual)
45
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Dulkadiroglu
-
Kahramanmaras, Dulkadiroglu, Pavo, 46100
- Hatice Adıgüzel
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
6 años a 18 años (Niño, Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
children with cerebral palsy and healty peer aged children
Descripción
Inclusion Criteria:
- Diagnosed with Hemiparetic and Diparetic CP with Gross Motor Function Classification System (GMFCS) Level ≤ 3
- Children with ≤ 2 upper extremity muscles according to the Modified Ashworth Scale (MAS)
- Children with Manual Skills Classification System (MACS) ≤ 3
- Not being diagnosed with mental disability by the RAM (Guidance Research Center)
- Children with CP aged 6-18 years
- Not receiving surgery or Botox (Botulinum Toxin) treatment in the last 6 months
- Children with CP with parental approval
Exclusion Criteria:
- Joint contracture in the shoulder, elbow and hand-wrist
- Having any hearing or vision problems
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
---|---|
1/Children with diparetic cerebral palsy
|
assessment of upper extremity functions, somatosensorial functions and proprioseption of upper extremity
|
2/Children with hemiparetic cerebral palsy
|
assessment of upper extremity functions, somatosensorial functions and proprioseption of upper extremity
|
3/healty peer aged children
|
assessment of upper extremity functions, somatosensorial functions and proprioseption of upper extremity
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
upper extremity proprioseption test
Periodo de tiempo: first day of assessment
|
Measurements will be done by a goniometer for bilateral upper extremity shoulder flexion-abduction, elbow flexion-extension, supination-pronation, hand-wrist flexion.
The eyes will be closed or the head turned to the opposite direction of the evaluated area.
The difference between the value for the full range and the value for the half range will be recorded on the test paper as angular.
Higher angular difference indicates worse proprioception.
|
first day of assessment
|
Kinesthesia Test
Periodo de tiempo: first day of assessment
|
The difference in the distance between the point where the child ends the movement and the end point of the real line is measured on the evaluation paper with a ruler.
The total value of the right and left obtained is recorded by subtracting from 50.
The higher the difference, the better the kinesthesia.
The test will be applied bilaterally.
|
first day of assessment
|
somatosensory perception of upper extremity (touch stimulus localization test)
Periodo de tiempo: first day of assesment
|
Touch stimulus localization test is one of the Ayres' Southern California Sensory Integration and Praxis Test (SIPT) somatosensory perception subtests.
Before starting the test, the child is asked to close his eyes.
The hand, wrist and forearm are touched once with a pencil in order, first in the pronation position and then in the supination position, and the child is asked to point to the touched area with his finger.
The distance between the place touched by the pen and the place indicated by the child is measured with a ruler and recorded on the evaluation sheet in cm.
The test is applied bilaterally.
Evaluation; The farther the distance between the real touched place and the child touches, the worse tactile perception is interpreted, the closer the real touched place and the child's touched place, the better it is interpreted to show tactile perception.
|
first day of assesment
|
somatosensory perception of upper extremity (double-touch stimulus localization test)
Periodo de tiempo: first day of assesment
|
Double-touch stimulus localization test is one of the Ayres' Southern California Sensory Integration and Praxis Test (SIPT) somatosensory perception subtests.
Before starting the test, the child is asked to close his eyes.
With 2 separate pens, you can simultaneously use two different points such as left hand-right cheek, right hand-left hand, left cheek-right cheek, left hand-left cheek, right hand-left cheek, right hand-right cheek while eyes are closed.
tactile.
The child is asked to say or show both points touched.
If the child knows both points, 2 points, 1 point if he knows one, 0 points if he does not know, and a total score is obtained.
In scoring, where the best value is measured out of 14, the lower this value is interpreted as the worse tactile perception, the closer it is to this value, the better tactile perception is interpreted.
|
first day of assesment
|
somatosensory perception of upper extremity (finger recognition test)
Periodo de tiempo: first day of assesment
|
Finger recognition test is one of the Ayres' Southern California Sensory Integration and Praxis Test (SIPT) somatosensory perception subtests.
Before starting the test, the child is asked to close his eyes.
He is asked to put his hands on the table and the child's eyes are closed and 16 different points (8 right hand-8 left hand) are touched with a pencil.
They are asked to point to the touched points with their fingers or to express audibly.
For each point touched, scoring is done as 1 for a correct answer and 0 for an incorrect answer.
The test was performed bilaterally.
The patient's total score is obtained by summing the scores for both hands.
In this measurement method, which is evaluated out of 16; The closer the value to 16 indicates good tactile perception, while the farther away it is, the worse it indicates tactile perception.
|
first day of assesment
|
somatosensory perception of upper extremity (right-left discrimination test)
Periodo de tiempo: first day of assesment
|
Right-left discrimination test is one of the Ayres' Southern California Sensory Integration and Praxis Test (SIPT) somatosensory perception subtests.
The child is asked to repeat the same by giving 10 body imitation commands.
With the paper with the test questions in the hands of the physiotherapist, the assessment of the child begins.
The score for the test is 2 points if he answers correctly in the first three seconds, 1 point if he answers in ten seconds, and 0 points if he fails to answer.
The total score is recorded by summing all the sub-scores of the child from the 10 questions in the test.
|
first day of assesment
|
The Jebsen Taylor Hand Function Test (JTHFT)
Periodo de tiempo: first day of assesment
|
The Jebsen Taylor Hand Function Test (JTHFT) will be used to assess upper extremity functional skills.
JTEFT, which is used in the 6-18 age range, consists of serial subtests representing hand function in daily life.
The application of this test, which consists of 6 items, takes 15-45 minutes.
A scaled board is used to provide a standard arrangement of objects in the test.
The time when all activities are done is recorded with a stopwatch.
Higher duration indicates worse hand function.
|
first day of assesment
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
manuel ability classification system (MACS)
Periodo de tiempo: first day of assessment
|
It is a classification system created to classify the hand skills of children with CP between the ages of 4-18, such as grasping and releasing objects in daily life, and how they use their hands while holding objects.
MACS defines five levels.
The higher level indicates worse hand function.
|
first day of assessment
|
Gross Motor Function Classification System(GMFCS)
Periodo de tiempo: first day of assessment
|
Gross motor function classification system (GMFCS) is a classification system developed by Palisano et al. in 1997 and expanded in 2007 to classify the gross motor functions of children with CP.
Gross motor function in children with CP is a standardized method that classifies motor function differences, especially in sitting and walking, at 5 levels.
A higher level indicates worse function.
|
first day of assessment
|
demographic information
Periodo de tiempo: first day of assessment
|
demographic information will be recorded (age, gender, height, weight)
|
first day of assessment
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
10 de enero de 2022
Finalización primaria (Actual)
20 de febrero de 2022
Finalización del estudio (Actual)
28 de febrero de 2022
Fechas de registro del estudio
Enviado por primera vez
15 de enero de 2022
Primero enviado que cumplió con los criterios de control de calidad
15 de enero de 2022
Publicado por primera vez (Actual)
28 de enero de 2022
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de abril de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
30 de marzo de 2022
Última verificación
1 de marzo de 2022
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- KSUU
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Parálisis cerebral
-
Indiana UniversityReclutamientoLesión cerebral traumática | Conmoción cerebral, grave | Conmoción cerebral, intermedia | Conmoción cerebral con pérdida breve de la conciencia | Lesión cerebral traumática con pérdida breve de la conciencia | Lesión cerebral traumática sin pérdida de conciencia | Conmoción cerebral con LOC 31... y otras condicionesEstados Unidos
-
UMC UtrechtTerminadoBypass cardiopulmonar | Perfusión Cerebral | Oxigenación CerebralPaíses Bajos
-
BrainScope Company, Inc.TerminadoLesiones Cerebrales Traumáticas | Conmoción cerebral, leve | Conmoción Cerebral | Conmoción cerebral, grave | Conmoción cerebral, intermediaEstados Unidos
-
BrainScope Company, Inc.United States Department of DefenseTerminadoLesiones Cerebrales Traumáticas | Conmoción cerebral, leve | Conmoción Cerebral | Conmoción cerebral, grave | Conmoción cerebral, intermediaEstados Unidos
-
Wake Forest University Health SciencesTerminadoSalud cerebral | Función del cerebro | Desarrollo cerebralEstados Unidos
-
Children's Hospital of PhiladelphiaNational Institute of Neurological Disorders and Stroke (NINDS)ReclutamientoLesión cerebral traumática leve | Conmoción cerebral, leve | Conmoción cerebral, grave | Conmoción cerebral, intermediaEstados Unidos
-
Oculogica, Inc.TerminadoLesiones Cerebrales | Trauma craneoencefálico | Trauma, Sistema Nervioso | Contusión cerebral | Conmoción cerebral, leve | Conmoción cerebral, grave | Conmoción cerebral, intermedia | Conmoción CerebralEstados Unidos
-
BrainScope Company, Inc.TerminadoLesiones Cerebrales Traumáticas | Conmoción cerebral, leve | Conmoción Cerebral | Conmoción cerebral, grave | Conmoción cerebral, intermediaEstados Unidos
-
Brent MaselThe Moody FoundationTerminadoLesión cerebral traumática crónicaEstados Unidos
-
Yu LiyunDesconocidoEl flujo sanguíneo cerebral | Presión de perfusión cerebral
Ensayos clínicos sobre assessment
-
Bispebjerg HospitalOdense University Hospital; Rigshospitalet, Denmark; Danish Cancer Society; Nordsjaellands... y otros colaboradoresTerminadoCuidados paliativosDinamarca
-
Centre Francois BaclesseTerminado
-
Bispebjerg HospitalDanish Cancer Society; Home care nursing in the Municipality of Gentofte; Home... y otros colaboradoresActivo, no reclutandoCuidados paliativosDinamarca
-
University of CataniaUniversity of Roma La Sapienza; Hospital General Universitario Santa Lucia; Klinik...Aún no reclutandoEsclerosis múltipleItalia
-
University Hospital, CaenDesconocido