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Parental Perspectives of Using Toy Cars on Social Interactions of Preschool Children With Mobility Impairments

8 de noviembre de 2016 actualizado por: University of Ulster

Parental Perspectives of Using Modified Toy Cars on the Social Interactions of Preschool Children With Mobility Impairments.

The purpose of this study is to investigate parental attitudes towards their child who has a mobility impairment, to using a modified electric toy car, and to evaluate from their perspective, if it facilitated social interaction for their child with mobility impairment.

Descripción general del estudio

Estado

Terminado

Intervención / Tratamiento

Descripción detallada

Project Aims:

The overall aim of the project is to investigate parental perspectives on the impact of using a modified electric toy car on social interactions of pre-school children with mobility impairments, over an 8 week period.

A secondary aim is to understand from the parent's perspective, features of the toy car they valued and features they feel could be changed to improve the experience for their child.

Methods:

Participants will be recruited via a charity in Northern Ireland who supports parents of children with Spina Bifida who have mobility impairments (SHINE). Once participants are confirmed, they will attend clinic appointments at Musgrave Park Hospital, Belfast. At clinic, the principle investigator will complete an assessment of the child to determine what modifications are required to support the child in the toy car as well as modifications to access drive functions.

The participants will be shown 3 possible toy car options and the child will have the opportunity to try driving the cars. Parents will then select the toy car they wish to use allowing them to consider aesthetic features. Giving the parents the option of selecting the car enhances patient and public involvement in the study.

Following this, the car will be ordered and modifications completed. The rehabilitation engineer will complete a medical device risk assessment on each car to ensure safety. A second appointment will then evaluate modifications, complete final adjustments and a safety handover.

Parents will be asked to use the toy car during social interactions with the child over an 8 week period. They will be asked to keep a log of their experiences over this time. Following this, the principle investigator will complete semi-structured interviews with the parents to determine their experiences of using the toy car.

Sample size: 5 child participants aged between 12 months and 47 months.

Outcome measures: Semi structured interviews will be completed with parents after 8 week trial intervention. In addition the PIADS will be completed before and after the trial to see if this can predict the likelihood for the parents to use the modified toy car, and what impact it has on their quality of life.

Tipo de estudio

Intervencionista

Inscripción (Actual)

5

Fase

  • No aplica

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

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Children aged between 12 months and 3 years, 11 months.
  • Parents or Guardians aged 18 years and over, fluent English language speakers.
  • Children who are unable to walk independently.
  • Children who have no experience of using powered wheelchairs.
  • Children who do not have a diagnosed severe learning disability.
  • Children, who are medically stable, do not require ventilation or suction and can maintain upright head positioning when seated on a flat surface.

Exclusion Criteria:

  • Children with a diagnosis of severe learning disability.
  • Children, who are currently medically unwell, require ventilation, suction and can't maintain an upright head position when seated on a flat surface.

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

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

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Toy car
The intervention is the provision of an electric toy car. This toy car will be modified to meet the postural and hand control preference of each child participant.

The intervention is the provision of an electric toy car. This toy car will be modified to meet the postural and hand control preference of each child participant.

The child will have the toy car for an 8 week trial period. Parents and child will be instructed in the safe use of the toy car, given written guidelines, and encouraged to use frequently.

Parents will keep a log of what days they use the toy car, where and for how long.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Parent Interview
Periodo de tiempo: on completion of 8 week trial
Semi-structured interview investigating impact on child's play and social experiences, reactions of child and others; barriers to using car; parent response and emotions to child using car; ideas to improve the experience; would they/child continue to use the toy car.
on completion of 8 week trial

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Psychosocial Impact of Assistive Devices Scale (PIADS) - Jutai & Day 2002
Periodo de tiempo: Baseline and on completion of 8 week trial
Standardised Questionnaire used to determine if the assistive device improves the perceived quality of life of users; and can predict the retention or abandonment of the device.
Baseline and on completion of 8 week trial

Colaboradores e Investigadores

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

Patrocinador

Investigadores

  • Silla de estudio: Jackie Casey, MSc, University of Ulster
  • Silla de estudio: Laura McKeown, PhD, University of Ulster

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

1 de febrero de 2016

Finalización primaria (Actual)

1 de junio de 2016

Finalización del estudio (Actual)

1 de septiembre de 2016

Fechas de registro del estudio

Enviado por primera vez

26 de enero de 2016

Primero enviado que cumplió con los criterios de control de calidad

9 de febrero de 2016

Publicado por primera vez (Estimar)

15 de febrero de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

9 de noviembre de 2016

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

8 de noviembre de 2016

Última verificación

1 de septiembre de 2016

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

On completion of study - data will be analyzed and disseminated through paper/ conference presentations. All data will be anonymized.

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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