Children Clinical Trial
Official title:
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.
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
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