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Magic Camp for Children With Hemiplegic Cerebral Palsy

20 de febrero de 2020 actualizado por: Hon K. Yuen, PhD, University of Alabama at Birmingham
The proposed study will test the feasibility and effectiveness of a "Magic Camp" in children with spastic hemiplegic cerebral palsy (CP). A single group pretest-posttest design (n=10) will be used to investigate the immediate (2 weeks) and longer-term effect (3 months) of a "Magic Camp" on improving upper limb motor function and health-related quality of life (HRQoL) in children with hemiplegic CP.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

This project will employ a single group pretest-posttest design to investigate the impact of a "Magic Camp" on the improvement in upper limb motor function, health-related quality of life, and emotional stress among children with spastic hemiplegic CP. After the baseline evaluation, eligible participants will complete one-on-one "magic trick" training 3-hours per day for 2 consecutive weeks. The primary outcome measures will be unimanual function as measured by the Jebsen Taylor Test of Hand Function, bimanual coordination as measured by kinematic parameters using motion analysis, and spontaneous use of the more affected limb in real-life activities that demand the use of both hands as measured by the Children's Hand Experience Questionnaire. Secondary outcome measures will include HRQoL as measured by the Cerebral Palsy Quality of Life Questionnaire, in-depth dyad qualitative interviews of the caregivers and children, and emotional stress as measured by the fingernail cortisol levels.

Tipo de estudio

Intervencionista

Inscripción (Actual)

7

Fase

  • No aplica

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

  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35294
        • University of Alabama at Birmingham

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

9 años a 18 años (Niño, Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • spasticity with Modified Ashworth Scale grades between 1 and 3;
  • ability to lift the more affected arm 15 cm above a table surface;
  • impairment of hand function at levels I to III of the Manual Activity Classification System
  • ability to grasp and release light objects with the more affected hand
  • largely nonuse of the more affected hand in daily activities as determined by the Pediatric Motor Activity Log
  • are interested in learning magic tricks
  • have the cognitive and social ability to participate in a camp setting;
  • ability to follow directions in English; and
  • ability to remember simple sequences of actions to perform magic tricks.

Exclusion Criteria:

  • severe muscle spasticity or fixed contracture in the more affected limb that limits functional arm and hand use
  • dystonia
  • severe visual or auditory disorders that prevent learning and carrying out the magic tricks
  • serious or recurring medical complications
  • participation in intensive upper limb intervention and/or musculoskeletal and tone management treatments, dorsal rhizotomy, or surgery on the upper limb in the previous 6 months or anticipated within subsequent 6 months
  • start muscle relaxant within the last 3 months; or
  • plan to move to another state within the next 6 months.

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

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Magic camp intervention
These children are diagnosed with cerebral palsy and we will provide motor control training.
Conductual: Magic camp intervention
Hand-arm bimanual motor skills training

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Unimanual skill as measured by the Jebsen Taylor Test of Hand Function
Periodo de tiempo: baseline
Jebsen Taylor Test of Hand Function (JTTHF) is a standardized timed test administered by occupational therapy (OT) students to assess the efficiency of unimanual grasp and release of items with six tasks. Higher scores (i.e., longer duration the participant takes to complete the task) represent poorer unimanual skills
baseline
Bimanual coordination as measured by 3-D kinematic motion analysis
Periodo de tiempo: baseline
Participants will be asked to perform the task with their preferred hand choice at a self-selected pace following by an auditory go-signal. Each trial ends when the button is pressed. Five trials will be collected after 2 practice trials, and outcome measures will be averaged over the 5 trials. Longer time duration it takes for the participant to complete the task represents poorer bimanual coordination.
baseline
Extent of the more affected hand use in daily bimanual activities as measured by the Children's Hand Experience Questionnaire (CHEQ)
Periodo de tiempo: Baseline
CHEQ is a 29-item (parent and child report) questionnaire that evaluates the experience of children in using the more affected hand in activities where usually two hands are required. Percentage use of the more affected hand will be expressed as percentage of independent activities performed bimanually in which the more affected hand is used to stabilize or grip items. Higher percentage (ranging from 0% to 100%) represents higher extent of using the more affected hand.
Baseline
Health-related quality of life as measured by the Cerebral Palsy Quality of Life (CPQOL) Questionnaire
Periodo de tiempo: Baseline
CPQOL evaluates the well-being of children with CP across several broad domains such as social well-being and acceptance, and emotional well-being. Items are rated on a 9-point scale, and recoded and transformed into scaled scores (transformed to a scale of 1-100) for each domain. An average of the scale scores from all domains (family & friends, school, communication, health, special equipment, pain and bother, and access to services) is conducted. Higher scores represent better health-related quality of life.
Baseline
Emotional stress as measured by the amount of cortisol in participants' and their caregivers' fingernails.
Periodo de tiempo: Baseline
Fingernail samples from every digit will be collected by clipping directly into a Ziploc® bag to avoid losing any parts of the sample. Nail samples will be sent to the Bio-Analytical Redox Biology (BARB) Core Laboratory, University of Alabama at Birmingham (UAB) for analysis.
Baseline

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Unimanual skill as measured by the Jebsen Taylor Test of Hand Function
Periodo de tiempo: from baseline to two weeks
Jebsen Taylor Test of Hand Function (JTTHF) is a standardized timed test administered by OT students to assess the efficiency of unimanual grasp and release of items with six tasks. Higher scores (i.e., longer duration the participant takes to complete the task) represent poorer unimanual skills.
from baseline to two weeks
Bimanual coordination as measured by 3-D kinematic motion analysis
Periodo de tiempo: from baseline to two weeks
Participants will be asked to perform the task with their preferred hand choice at a self-selected pace following by an auditory go-signal. Each trial ends when the button is pressed. Five trials will be collected after 2 practice trials, and outcome measures will be averaged over the 5 trials.Longer time duration it takes for the participant to complete the task represents poorer bimanual coordination.
from baseline to two weeks
Extent of the more affected hand use in daily bimanual activities as measured by the Children's Hand Experience Questionnaire (CHEQ)
Periodo de tiempo: from baseline to two weeks
CHEQ is a 29-item (parent and child report) questionnaire that evaluates the experience of children in using the more affected hand in activities where usually two hands are required. Percentage use of the more affected hand will be expressed as percentage of independent activities performed bimanually in which the more affected hand is used to stabilize or grip items. Higher percentage (ranging from 0% to 100%) represents higher extent of using the more affected hand.
from baseline to two weeks
Health-related quality of life as measured by the Cerebral Palsy Quality of Life (CPQOL) Questionnaire
Periodo de tiempo: from baseline to two weeks
CPQOL evaluates the well-being of children with CP across several broad domains such as social well-being and acceptance, and emotional well-being. Items are rated on a 9-point scale, and recoded and transformed into scaled scores for each domain. An average of the scale scores from all domains (family & friends, school, communication, health, special equipment, pain and bother, and access to services) is conducted. Higher scores represent better health-related quality of life.
from baseline to two weeks
Unimanual skill as measured by the Jebsen Taylor Test of Hand Function
Periodo de tiempo: from two weeks to three months
Jebsen Taylor Test of Hand Function (JTTHF) is a standardized timed test administered by OT students to assess the efficiency of unimanual grasp and release of items with six tasks. Higher scores (i.e., longer duration the participant takes to complete the task) represent poorer unimanual skills.
from two weeks to three months
Bimanual coordination as measured by 3-D kinematic motion analysis
Periodo de tiempo: from two weeks to three months
Participants will be asked to perform the task with their preferred hand choice at a self-selected pace following by an auditory go-signal. Each trial ends when the button is pressed. Five trials will be collected after 2 practice trials, and outcome measures will be averaged over the 5 trials. Longer time duration it takes for the participant to complete the task represents poorer bimanual coordination.
from two weeks to three months
Extent of the more affected hand use in daily bimanual activities as measured by the Children's Hand Experience Questionnaire (CHEQ)
Periodo de tiempo: from two weeks to three months
CHEQ is a 29-item (parent and child report) questionnaire that evaluates the experience of children in using the more affected hand in activities where usually two hands are required. Percentage use of the more affected hand will be expressed as percentage of independent activities performed bimanually in which the more affected hand is used to stabilize or grip items. Higher percentage (ranging from 0% to 100%) represents higher extent of using the more affected hand.
from two weeks to three months
Health-related quality of life as measured by the Cerebral Palsy Quality of Life (CPQOL) Questionnaire
Periodo de tiempo: from two weeks to three months
CPQOL evaluates the well-being of children with CP across several broad domains such as social well-being and acceptance, and emotional well-being. Items are rated on a 9-point scale, and recoded and transformed into scaled scores for each domain. An average of the scale scores from all domains (family & friends, school, communication, health, special equipment, pain and bother, and access to services) is conducted. Higher scores represent better health-related quality of life.
from two weeks to three months
Emotional stress as measured by the amount of cortisol in participants' and their caregivers' fingernails.
Periodo de tiempo: from baseline to three months
Fingernail samples from every digit will be collected by clipping directly into a Ziploc® bag to avoid losing any parts of the sample. Nail samples will be sent to the BARB Core Laboratory, UAB for analysis.
from baseline to three months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of Alabama at Birmingham

Investigadores

  • Investigador principal: Hon K Yuen, PhD, University of Alabama at Birmingham

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)

4 de junio de 2018

Finalización primaria (Actual)

1 de octubre de 2018

Finalización del estudio (Actual)

31 de diciembre de 2018

Fechas de registro del estudio

Enviado por primera vez

2 de agosto de 2018

Primero enviado que cumplió con los criterios de control de calidad

2 de agosto de 2018

Publicado por primera vez (Actual)

8 de agosto de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

24 de febrero de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

20 de febrero de 2020

Última verificación

1 de febrero de 2020

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • IRB-300001044

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

producto fabricado y exportado desde los 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. .

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