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Human-Animal Interaction to Promote Recovery Following Pediatric Brain Injury (AAT)

9 de julio de 2019 actualizado por: Children's Hospital Medical Center, Cincinnati

Huma-Animal Interaction to Promote Recovery Following Pediatric Brain Injury

This study evaluates the addition of therapy dogs in inpatient physical and occupational therapy. Data will be collected across 10 PT and 10 OT sessions, half of which will incorporate a therapy dog.

Descripción general del estudio

Estado

Desconocido

Condiciones

Intervención / Tratamiento

Descripción detallada

Children with acquired brain injuries (ABI) treated on an inpatient rehabilitation unit are at significant risk for long term functional impairment, highlighting the importance of maximizing the effectiveness and utilization of inpatient rehabilitation therapies. The proposed study seeks to explore the value of animal-assisted therapy (AAT) during inpatient rehabilitation following pediatric ABI. Investigators will employ a within subjects cross-over trial; all participants will have a volunteer dog involved in 50% of their physical therapy (PT) and occupational therapy (OT) sessions over a 2-week study period. AAT will consist of integration of a dog from the hospital volunteer dog program in PT and OT sessions, while the non-AAT condition will be treatment as usual (TAU) as identified by the patients' treatment team. Information regarding patient engagement/participation in therapy, affect, and physiological variables will be collected during each session. Session notes will also be coded for additional qualitative information. Qualitative feedback from patients and families, therapists, medical teams, and dog handlers will also be collected throughout the project to examine feasibility and satisfaction with the intervention as well as potential barriers and areas for improvement. Investigators will 1) examine the effect of AAT on level of patient participation and patient affect during PT and OT sessions, 2) Explore the effect of AAT on functional outcomes using a historic cohort comparison group, and 3) explore the physiological response of patients, and examine a number of variables (injury type/severity, child sex and anthropomorphism, therapist factors, and dog handler factors) to begin to determine which patients are most likely to benefit from AAT during inpatient rehabilitation for ABI.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

40

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.

Estudio Contacto

Ubicaciones de estudio

  • Estados Unidos
    • Ohio
      • Cincinnati, Ohio, Estados Unidos, 45229
        • Cincinnati Children's Hospital Medical Center
        • Contacto:

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 y mayores (Niño, Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Diagnosis: Participants must be on the inpatient rehabilitation unit for treatment of an acquired brain injury (TBI, brain tumor, infection, stroke, etc)
  • Consent: The family must provide informed consent by parents or legal guardians
  • Assent: The adolescent must provide a signature indicating assent to participate in the study.
  • Age at time of screening: 6 years old and older with no upper limit
  • Responsiveness: Rancho score greater than 2 (or equivalent) at the time of enrollment (as noted in medical chart)

Exclusion Criteria:

  • Animals: Participant has a significant allergy to dogs or have a significant fear of dogs.
  • Disease: Participant has a communicable disease that may pose a risk to dog or dog handler or a compromised immune system where interacting with dog and/or handler would be of significant risk to patient.
  • Responsiveness: Rancho score of 2 (or equivalent) or less
  • Cognitive issues: Participants with pre-injury/pre-diagnosis of developmental delay, autism, and/or patients who are non-verbal will be excluded.

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 cruzada
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Animal Assisted Therapy - Dog Session
Therapy dog added to PT and OT session
Otro: AAT - Dog
therapy dog added to inpatient PT and OT session
Comparador activo: Treatment as usual - No Dog session
No dog added to PT and OT session - PT and OT session as usual standard of care
Otro: TAU - No Dog
PT and OT as usual without the addition of therapy dog

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Patient Participation - AAT
Periodo de tiempo: Throughout study completion, an average of 2 weeks
Patient participation during AAT sessions will be assessed using the Pittsburgh Rehabilitation Participation Scale (PRPS)The PRPS is a 6-item Likert-type, clinician-rated measure that quantifies observed patient participation in their therapy session. Therapists report their observations regarding patient's completion of exercises, effort applied to exercises, and level of support needed to complete activities. Scores range from 1 (None) to 6 (excellent). Therapists will complete this measure at the end of each AAT session. Ratings across the 5 (on average) AAT sessions will be used to create an patient participation - AAT score.
Throughout study completion, an average of 2 weeks
Patient Participation - TAU
Periodo de tiempo: Throughout study completion, an average of 2 weeks
Patient participation during TAU sessions will be assessed using the Pittsburgh Rehabilitation Participation Scale (PRPS)The PRPS is a 6-item Likert-type, clinician-rated measure that quantifies observed patient participation in their therapy session. Therapists report their observations regarding patient's completion of exercises, effort applied to exercises, and level of support needed to complete activities. Scores range from 1 (None) to 6 (excellent). Therapists will complete this measure at the end of each TAU session. Scores across the 5 (on average) TAU sessions will be used to create a single patient participation - TAU score.
Throughout study completion, an average of 2 weeks
Objective session participation - AAT
Periodo de tiempo: Throughout study completion, an average of 2 weeks
Objective session participation will be assessed via videotaped sessions for at least 2 AAT sessions. Coders will provide an objective measure of participation by rating patient in session participation using the Pittsburgh Rehabilitation Participation Scale (PRPS). Coders will score participation using the PRPS and rate the participants level of participation from 1 (None) to 6 (Excellent). These coder ratings will be used to create an overall objective session participation AAT score.
Throughout study completion, an average of 2 weeks
Objective session participation - TAU
Periodo de tiempo: Throughout study completion, an average of 2 weeks
Objective session participation will be assessed via videotaped sessions for at least 2 TAU sessions. Coders will provide an objective measure of participation by rating patient in session participation using the Pittsburgh Rehabilitation Participation Scale (PRPS). Coders will score participation using the PRPS and rate the participants level of participation from 1 (None) to 6 (Excellent). These coder ratings will be used to create an overall objective session participation TAU score.
Throughout study completion, an average of 2 weeks
Patient Affect - AAT
Periodo de tiempo: Throughout study completion, an average of 2 weeks
Patient affect will be assessed via the Symptom Inventory Scale - Short.This measure is a 4-item measure, where the patient reports the degree (from 0-10) they are experiencing each feeling/condition presented (Happy, fatigue, distraction, irritability). The patient will be asked to complete this measure at the beginning and end of each AAT session. These ratings will be used to create happy, fatigue, distracted, and irritable - AAT scores. Greater scores are reflective of greater levels of that emotion.
Throughout study completion, an average of 2 weeks
Patient Affect - TAU
Periodo de tiempo: Throughout study completion, an average of 2 weeks
Patient affect will be assessed via the Symptom Inventory Scale - Short.This measure is a 4-item measure, where the patient reports the degree (from 0-10) they are experiencing each feeling/condition presented (Happy, fatigue, distraction, irritability). The patient will be asked to complete this measure at the beginning and end of each TAU session. These ratings will be used to create happy, fatigue, distracted, and irritable - TAU scores. Greater scores are indicative of greater levels of that emotion.
Throughout study completion, an average of 2 weeks
Objective mood assessment - AAT
Periodo de tiempo: Throughout study completion, an average of 2 weeks
Objective mood assessment will be completed for at least 2 AAT sessions via coding of video taped sessions. Coders naïve to hypotheses will assess the percentage of time the patient displays positive and negative affect. Greater scores. Greater scores are indicative of greater levels of positive and negative affect. Scores across all coded AAT sessions will be used to create a positive affect-AAT score and negative affect-AAT score.
Throughout study completion, an average of 2 weeks
Objective mood assessment - TAU
Periodo de tiempo: Throughout study completion, an average of 2 weeks
Objective mood assessment will be completed for at least 2 TAU sessions via coding of video taped sessions. Coders naïve to hypotheses will assess the percentage of time the patient displays positive and negative affect. Greater scores. Greater scores are indicative of greater levels of positive and negative affect. Scores across all coded TAU sessions will be used to create a positive affect-TAU score and negative affect-TAU score.
Throughout study completion, an average of 2 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Heart rate- AAT
Periodo de tiempo: Throughout study completion, an average of 2 weeks
Heart rate will be collected using an Empatica E4 wristband during each of the AAT sessions. The patient will wear the wrist band during all sessions, and data collected during AAT sessions will be summarized as heart rate - AAT,
Throughout study completion, an average of 2 weeks
Temperature - AAT
Periodo de tiempo: Throughout study completion, an average of 2 weeks
Temperature will be collected using an Empatica E4 wristband during each of the AAT sessions. The patient will wear the wrist band during all sessions, and data collected during AAT sessions will be summarized as temperature-AAT.
Throughout study completion, an average of 2 weeks
Galvanic Skin Response - AAT
Periodo de tiempo: Throughout study completion, an average of 2 weeks
Galvanic skin response (GSR) will be collected using an Empatica E4 wristband during each of the AAT sessions. The patient will wear the wrist band during all sessions, and data collected during AAT sessions will be summarized as GSR-AAT.
Throughout study completion, an average of 2 weeks
Heart Rate - Tau
Periodo de tiempo: Throughout study completion, an average of 2 weeks
Heart rate will be collected using an Empatica E4 wristband during each of the TAU sessions. The patient will wear the wrist band during all sessions, and data collected during TAU sessions will be summarized as heart rate - TAU.
Throughout study completion, an average of 2 weeks
Temperature - Tau
Periodo de tiempo: Throughout study completion, an average of 2 weeks
Temperature, and galvanic skin response will be collected using an Empatica E4 wristband during each of the TAU sessions. The patient will wear the wrist band during all sessions, and data collected during TAU sessions will be summarized as temperature-TAU.
Throughout study completion, an average of 2 weeks
Galvanic skin response - Tau
Periodo de tiempo: Throughout study completion, an average of 2 weeks
Galvanic skin response (GSR) will be collected using an Empatica E4 wristband during each of the TAU sessions. The patient will wear the wrist band during all sessions, and data collected during TAU sessions will be summarized as GSR-TAU.
Throughout study completion, an average of 2 weeks

Colaboradores e Investigadores

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

Patrocinador

Children's Hospital Medical Center, Cincinnati

Colaboradores

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigadores

  • Investigador principal: Megan Narad, PhD, Children's Hospital Medical Center, Cincinnati

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 (Anticipado)

1 de julio de 2019

Finalización primaria (Anticipado)

31 de julio de 2020

Finalización del estudio (Anticipado)

31 de julio de 2020

Fechas de registro del estudio

Enviado por primera vez

3 de mayo de 2019

Primero enviado que cumplió con los criterios de control de calidad

9 de julio de 2019

Publicado por primera vez (Actual)

12 de julio de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

12 de julio de 2019

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

9 de julio de 2019

Última verificación

1 de julio de 2019

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CIN001-AAT
  • 1R21HD095132-01 (Subvención/contrato del NIH de EE. UU.)

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. .

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