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Sensitivity of an Upper Limb Motion Analysis Protocol to Changes in Kinematics and Muscle Activity After Constraint Induced Therapy in Children With Hemiplegia (MouvsupTCIHemi)

7 de junio de 2019 actualizado por: Nantes University Hospital

Quantified Analysis of the Movements of the Upper Limb of Children With Hemiparesis Participating in the Stress Induced Therapy Program

In France, Cerebral Palsy (CP) affects 1 in 450 births. It results from lesions of the brain, before, during, or shortly after birth. These non-progressive lesions cause muscle impairments, responsible for activity limitations. These muscle impairments include muscle stiffness, and muscle weakness. Children with Unilateral CP (UCP) have these impairments on only one side of the body. To compensate for activity limitations with their impaired arm, these children over-use their non-impaired arm. The objective of constraint-induced therapy (CIT) is to minimize this asymmetry which deteriorates mobility on the impaired side, by forcing the child to only use its impaired arm several hours a day during several weeks of therapy. It is known using clinical tests that this therapy improves the overall motor function of the impaired arm. However, the underlying mechanisms are yet unknown. An understanding of these mechanisms would suggest ways to maximize the effectiveness of this therapy, which requires a significant commitment from the child and its family. The investigaors propose in this project a quantitative and objective evaluation of the effect of CIT on the movements of the impaired arm of children with UCP. The investogators focus their analysis on muscle activation, to assess which aspect of muscle impairments is modified by CIT. To this end, the investigators will use sensors identical to those already used in clinics for the Quantified Gait Analysis of children with CP, recognized since 2006 by the Haute Autorité de Santé as providing key supplementary data in the evaluation of complex gait disorders. Results from this study will provide leads to optimize CIT. Some children could for example benefit from CIT paired with treatments to reduce muscle stiffness or to strengthen muscles

Descripción general del estudio

Descripción detallada

Quantitative and objective evaluation of upper limb movements will take place in a motion analysis laboratory and will take place as follow:

  • A clinical exam of the participant will be performed by the physician to collect maximal passive joint amplitudes with a goniometer and anatomical measures (length, circumference) of the upper limb.
  • The participant will be equipped with surface electromyographic electrodes to measure the activation of his superficial muscles, and with retroreflective markers placed on anatomical landmarks of his thorax, shoulder, and arm, to measure upper limb kinematics with a 3D motion capture system composed of 8 VICON cameras.
  • Maximal forces of elbow pronosupination and flexion-extension will be measured with a portable dynamometer.
  • The participant will be placed on a height adjustable bench, in the center of the laboratory. He will be asked to perform upper limb movements:

    • A few movements not measured, to familiarize with the equipment;
    • Recorded movements: a trial is composed of a few consecutive cycles of a movement such as elbow flexion-extension. A trial usually last about 10seconds. A few seconds-time of rest is imposed between each trial. The required movements are the following: elbow flexion-extension, elbow pronosupination, and "hand to mouth".
  • Finally, the participant will be asked to lie down on an exam table and to rest relax, in order to measure the electromyographic signal of his muscles at rest.

Duration of the protocol is about 1h30, with less than 30seconds of effort, and a few minutes of performing simple upper limb movements.

Tipo de estudio

Intervencionista

Inscripción (Actual)

28

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

      • Nantes, Francia, 46208
        • CHU de Nantes

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 17 años (Niño)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Participants (excluding healthy volunteers) must have hemiparesis.
  • Children must be between 6 and 17 years of age. The protocol requires a minimum concentration difficult to obtain for children under 6 years.
  • Participants must be enrolled in a health insurance plan.

Exclusion Criteria:

  • Inability to understand or follow instructions during 1h30.
  • Physical incapacity to carry out the requested movements

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: Otro
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Otro: A: Healthy volunteers
Maximal forces of elbow pronosupination and flexion-extension will be measured with a portable dynamometer.
Otro: B: Patient with heamiplegia
Maximal forces of elbow pronosupination and flexion-extension will be measured with a portable dynamometer.
Otro: C: Patient with heamiplegia and constraint induced therapy
arm with constraint induced therapy (done before the protocol)
Maximal forces of elbow pronosupination and flexion-extension will be measured with a portable dynamometer.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Upper limb muscle activation envelopes
Periodo de tiempo: 5 weeks
Muscle activation envelopes come from electromyographic signals of upper limb muscles.
5 weeks
kinematics during active movements
Periodo de tiempo: 5 weeks
Kinematics: angles, velocities, accelerations of the thorax, shoulder, elbow and wrist in the three anatomical plans (sagittal, frontal, transverse).
5 weeks

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)

28 de marzo de 2017

Finalización primaria (Actual)

17 de abril de 2019

Finalización del estudio (Actual)

17 de abril de 2019

Fechas de registro del estudio

Enviado por primera vez

20 de marzo de 2017

Primero enviado que cumplió con los criterios de control de calidad

28 de marzo de 2017

Publicado por primera vez (Actual)

4 de abril de 2017

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de junio de 2019

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

7 de junio de 2019

Última verificación

1 de junio de 2019

Más información

Términos relacionados con este estudio

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 Unilateral

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