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Investigating the Effect of Stochastic Resonance Vibration on Gait and Balance and Upper Extremity Function in Children With Cerebral Palsy

11 de enero de 2022 actualizado por: Virginia Commonwealth University
The purpose of this research study is to determine the effects of wearable vibration devices for children with cerebral palsy and impaired arm function.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

Vibration devices have been used by some patients with cerebral palsy during therapy sessions. Researchers believe they have the potential to be even more useful for everyday use, and are doing this study to learn more about what they can do.

Participate in this study will be asked to complete assessments that test arm motion, muscle tone, motor control, and sensory function. They will then be asked to wear a wristband on each wrist and on their shoulder. These wristbands contain vibrators that can vibrate at different levels. The vibrations are caused by a low-level of sound waves that people may barely be able to hear. While wearing the vibration devices on the wrist and shoulder, participants will be asked to perform two tasks. The first task is called the box and blocks test, which consists of transferring wooden blocks from one box to another. The second test is called the Shriners upper extremity evaluation (SHUEE). In this test participants will perform a series of fine motor tasks with their hands. The SHUEE test will be video recorded for scoring by a study therapist at a later time on how much and how well participants use their impaired arm to perform the tasks. Participants will be asked to complete the box and blocks test and the SHUEE test 3 times. Participation in this study will be one single visit and last approximately an hour to an hour and a half.

Tipo de estudio

Intervencionista

Inscripción (Actual)

16

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

    • Virginia
      • Richmond, Virginia, Estados Unidos, 23298
        • Virginia Commonwealth University

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

3 años a 18 años (Niño, Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Diagnosed with cerebral palsy
  • 3 years to 18 years of age
  • Able to reliably express pain, discomfort or fear as reported by the parent/guardian
  • Manual ability classification scale (MACS) levels I, II or III

Exclusion Criteria:

  • Any unstable medical condition. An unstable medical condition is a state of imminent threat to life such as shock, acute asthma, respiratory distress, severe infection and sepsis. Any patient in a clinic or therapy center presenting with signs and symptoms of an unstable medical condition will be directed to emergency medical services
  • Any medical condition preventing active rehabilitation reported by the parent/guardian such as:

    o Thromboembolic disease, acute progressive neurological disorder, cardiovascular or pulmonary contraindications, aggressive behavior, severe cognitive deficits, joint instabilities and compromised bone health, recent or non-consolidated fractures, osteoporosis

  • Subjects with cardiac pacemakers, electronic pumps or any other implanted medical devices
  • Skin lesions affecting the areas where the device straps will be attached to the body

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: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: stochastic resonance (SR) vibration
SR applied sub threshold at 90% of participant's detection threshold
SR wraps will be applied to the one or both wrists depending on whether the impairment is unilateral or bilateral. Two additional actuators will be secured around the shoulder. The threshold for detection of SR will be determined by the examiner prior to initiating the test condition. The intensity of the stimulation is adjustable with a scroll bar on the app and ranges from a 0 - 100. The examiner will gradually increase the stimulus intensity until the participant reports being able to feel it. This will set the participant's detection threshold.
Comparador falso: Sham treatment
SR devices worn but not turned on (0% of participant's detection threshold).
SR wraps will be applied to the one or both wrists depending on whether the impairment is unilateral or bilateral. Two additional actuators will be secured around the shoulder. The threshold for detection of SR will be determined by the examiner prior to initiating the test condition. The intensity of the stimulation is adjustable with a scroll bar on the app and ranges from a 0 - 100. The examiner will gradually increase the stimulus intensity until the participant reports being able to feel it. This will set the participant's detection threshold.
Experimental: Unblinded treatment
SR is applied above participant's detection threshold at a participant selected intensity.
SR wraps will be applied to the one or both wrists depending on whether the impairment is unilateral or bilateral. Two additional actuators will be secured around the shoulder. The threshold for detection of SR will be determined by the examiner prior to initiating the test condition. The intensity of the stimulation is adjustable with a scroll bar on the app and ranges from a 0 - 100. The examiner will gradually increase the stimulus intensity until the participant reports being able to feel it. This will set the participant's detection threshold.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Manual Dexterity
Periodo de tiempo: Baseline to up to 1.5 hours
Manual dexterity is will be assessed using the Box and Block (B&B) test. The B&B test is scored by counting the number of blocks transferred during the 1 minute test. Higher scores indicate better manual dexterity. Change was assessed after each condition and compared to baseline.
Baseline to up to 1.5 hours
Change in Upper Extremity Functionality
Periodo de tiempo: Baseline to up to 1.5 hours
Upper extremity functionality will be assessed using the Shriners Upper Extremity Evaluation (SHUEE). Participants are observed and scored by a trained rater blind to the condition. Scores range from 0 to 45 for spontaneous functional activity and from 0 to 72 for dynamic positional analysis. Higher scores indicate better functionality.
Baseline to up to 1.5 hours

Colaboradores e Investigadores

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

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 julio de 2020

Finalización primaria (Actual)

14 de noviembre de 2020

Finalización del estudio (Actual)

14 de noviembre de 2020

Fechas de registro del estudio

Enviado por primera vez

13 de mayo de 2020

Primero enviado que cumplió con los criterios de control de calidad

13 de mayo de 2020

Publicado por primera vez (Actual)

14 de mayo de 2020

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de enero de 2022

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

11 de enero de 2022

Última verificación

1 de enero de 2022

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • HM20018459

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.

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

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