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Intensive Home-based Treadmill Training and Walking Attainment in Young Children With Cerebral Palsy

18 de junio de 2020 actualizado por: Katrin Mattern-Baxter, California State University, Sacramento
This study is designed to find the optimal dosage of home-based treadmill training needed to accelerate walking onset and to examine the long-term effects on the child's walking activity.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

The purpose of this study is to determine optimal parameters for dosing home-based treadmill training by comparing high-intensity (5 days/week, twice daily for 10-20 min for 6 weeks) to low-intensity (2 days/week, once daily for 10-20 minutes for 6 weeks) treadmill training; and to compare the effects of high- versus low-intensity treadmill training on walking attainment and overall walking activity in young children with cerebral palsy.

Hypotheses

  • A more intensive protocol of treadmill training will increase walking onset in young children with CP.
  • A more intensive protocol of treadmill training will increase overall walking activity in young children with CP.

Specific Aims

  • To determine optimal parameters for dosing home-based treadmill training by comparing high-intensity to low-intensity home-based treadmill training.
  • To compare the effects of high- versus low-intensity treadmill training on walking onset and overall walking activity.

Study design •Prospective randomized controlled trial

Study population

•Two groups of 12 children with CP under the age of 3 years and are not walking yet will receive either home-based high-intensity treadmill training or low-intensity treadmill training. The children will be assessed before, immediately after, at 1-month and at 4-months following the intervention via standardized outcome measures.

Tipo de estudio

Intervencionista

Inscripción (Actual)

19

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
    • Washington
      • Seattle, Washington, Estados Unidos, 98145
        • Seattle Children's Research Institute
      • Tacoma, Washington, Estados Unidos, 98416
        • University of the Puget Sound

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

1 año a 3 años (Niño)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Signs of walking readiness as demonstrated by the ability to sit for 30 seconds when placed and to take 5 to 7 steps when supported at the trunk or arms.

  • Because young children often are not formally diagnosed with CP until 2 years of age, we will include children

    • who show bilateral impairment (i.e. diplegia and quadriplegia, but not hemiplegia)
    • who demonstrate upper motor neuron signs (i.e. spasticity and/or hyperreflexia)
    • who have been identified as high-risk for a motor disability by a physician

Exclusion Criteria:

  • a history of uncontrolled seizures
  • a diagnosis of a genetic disorder
  • cardiac or orthopedic contraindications for standing and walking
  • orthopedic surgery in the past 6 months
  • use of spasticity-reducing medication or Botox injections in the past 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: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: high-intensity group
Children will engage in home-based treadmill training 5 days/week, twice daily for 10-20 min for 6 weeks
Otro: home-based treadmill training
the child will walk on a pediatric treadmill with the help of the parent/caregiver and with weekly supervision of a physical therapist
Dispositivo: Rueda de andar
Comparador activo: low-intensity group
Children will engage in home-based treadmill training 2 days/week, once daily for 10-20 minutes for 6 weeks
Otro: home-based treadmill training
the child will walk on a pediatric treadmill with the help of the parent/caregiver and with weekly supervision of a physical therapist
Dispositivo: Rueda de andar

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Gross Motor Function Measure Dimension E
Periodo de tiempo: assessed at 6 weeks, 1 month, 4 months from baseline
The Gross Motor Function Measure is a criterion-referenced test of gross motor function for children with cerebral palsy ages 5 months to 15 years. It contains 5 Dimensions (A-E). Dimension E is related to the child's gross motor skills related to walking, running and jumping and is assessed by observation. Dimension E contains 24 gross motor skills. Each of these motor skills is rated either 0 (does not initiate), 1(initiates), 2 (partially completes), 3 (completes) or NT( not tested). The total possible Dimension E score is 72 with a range of 0-72. Scores can be converted into a percent score by dividing the child's achieved points by the number of possible points. Higher scores and a higher percentage indicate better performance in walking, running and jumping. Change from baseline in total points, not in percentage, is reported.
assessed at 6 weeks, 1 month, 4 months from baseline
Walking Activity Measured by StepWatch
Periodo de tiempo: StepWatch data was collected for all awake daytime hours over a 7 day period at study onset before treadmill training commences and at 6 weeks, 1 month, 4 months.
StepWatch data records the child's walking activity in minutes/day. It is collected via an accelerometer attached to the distal leg and worn at all waking hours except during sleep and bath time.Higher numbers of active minutes indicate higher level of activity. Changes from baseline are reported.
StepWatch data was collected for all awake daytime hours over a 7 day period at study onset before treadmill training commences and at 6 weeks, 1 month, 4 months.
Gross Motor Function Measure Dimension D
Periodo de tiempo: assessed at 6 weeks, 1 month, 4 months from baseline
The Gross Motor Function Measure is a criterion-referenced test of gross motor function for children with cerebral palsy ages 5 months to 15 years. It contains 5 Dimensions (A-E).Dimension D is a test of gross motor function related to standing ability. The child's gross motor skills related to standing are assessed by observation. The test contains 13 gross motor skills. Each of these motor skills is rated either 0 (does not initiate), 1(initiates), 2 (partially completes), 3 (completes) or NT( not tested). The total possible Dimension D score is 39 with a range of 0-39. Scores can be converted into a percent score by dividing the child's achieved points by the number of possible points. Higher scores and a higher percentage indicate better performance in standing. Change from baseline in total points, not in percentage, is reported.
assessed at 6 weeks, 1 month, 4 months from baseline

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Pediatric Evaluation of Disability Index-Mobility Subscale
Periodo de tiempo: pre-intervention, at 6 weeks, at 1-month and at 4-months following the intervention
The Pediatric Evaluation of Disability Index is a valid and reliable tool that provides an assessment of a child's functional status and performance via observation and parent report.The Mobility Subscale examines the child's functional skills related to movement. There are a total of 13 motor categories on the Mobility Subscale, with 5 possible motor skills in each category, for a total of 65 distinct motor skills. Skills are marked as 0 (not observed) or 1 (observed) and added.There are a total of 65 possible points with a range of 0-65 points on the Mobility Subscale. Higher scores indicate greater function.Scores are reported as changes from baseline.
pre-intervention, at 6 weeks, at 1-month and at 4-months following the intervention
Timed 10-meter Walk Test
Periodo de tiempo: assessed at 6 weeks, at 1-month and at 4-months following the intervention
The child's walking speed is recorded over 10 meters if the child is able to walk with or without an assistive device. The speed is timed and reported in seconds. Fewer seconds indicate a faster walking speed. Time in seconds is reported as change from baseline.
assessed at 6 weeks, at 1-month and at 4-months following the intervention
Peabody Developmental Motor Scales-2 -Locomotion Subscale
Periodo de tiempo: assessed at 6 weeks, at 1-month and at 4-months
Peabody Developmental Motor Scales-2 is a norm-referenced standardized test of gross and fine motor performance for children from birth through age 5.The Locomotion Subscale examines the ability of the child to move through space. It contains a total of 89 motor skills. The child is rated on each skill on a scale of 0 (unable), 1 (partial) or 2 (complete) and the scores are added for a total possible raw score of 178 and a range of 0-178. Higher raw scores indicate a better outcome.The raw scores can be converted to standard scores, age equivalents and percentiles Raw scores of the Locomotion subscale are reported based on changes from baseline.
assessed at 6 weeks, at 1-month and at 4-months
1-minute Walk Test
Periodo de tiempo: assessed at 6 weeks, 1 month, 4 months
The child's walking distance is measured in meters over 1 minute at their self-selected walking speed if the child is able to walk with or without an assistive device.The walking distance is reported in meters. More meters indicate more distance covered. Values are reported in meters as changes from baseline.
assessed at 6 weeks, 1 month, 4 months

Colaboradores e Investigadores

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

Patrocinador

California State University, Sacramento

Colaboradores

Seattle Children's Hospital
Thrasher Research Fund
University of Puget Sound

Investigadores

  • Director de estudio: David Earwicker, BA,MA, California State University, Sacramento

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

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)

1 de julio de 2015

Finalización primaria (Actual)

1 de septiembre de 2018

Finalización del estudio (Actual)

1 de septiembre de 2018

Fechas de registro del estudio

Enviado por primera vez

16 de abril de 2015

Primero enviado que cumplió con los criterios de control de calidad

22 de abril de 2015

Publicado por primera vez (Estimar)

23 de abril de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de julio de 2020

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

18 de junio de 2020

Última verificación

1 de junio de 2020

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 13-14-156

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

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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