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

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ClinicalTrials.gov Identifier: NCT02682043
Recruitment Status : Completed
First Posted : February 15, 2016
Last Update Posted : November 9, 2016
Sponsor:
Collaborator:
Belfast Health and Social Care Trust
Information provided by (Responsible Party):
University of Ulster

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Children Mobility Limitation Spina Bifida Attitude to Health Device: Toy car Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Parental Perspectives of Using Modified Toy Cars on the Social Interactions of Preschool Children With Mobility Impairments.
Study Start Date : February 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Toddler Health

Arm Intervention/treatment
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.
Device: 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 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.





Primary Outcome Measures :
  1. Parent Interview [ Time Frame: 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.


Secondary Outcome Measures :
  1. Psychosocial Impact of Assistive Devices Scale (PIADS) - Jutai & Day 2002 [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Months to 47 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02682043


Sponsors and Collaborators
University of Ulster
Belfast Health and Social Care Trust
Investigators
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Study Chair: Jackie Casey, MSc University of Ulster
Study Chair: Laura McKeown, PhD University of Ulster
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Responsible Party: University of Ulster
ClinicalTrials.gov Identifier: NCT02682043    
Other Study ID Numbers: 15/0131
First Posted: February 15, 2016    Key Record Dates
Last Update Posted: November 9, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: On completion of study - data will be analyzed and disseminated through paper/ conference presentations. All data will be anonymized.
Additional relevant MeSH terms:
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Spinal Dysraphism
Mobility Limitation
Neural Tube Defects
Nervous System Malformations
Nervous System Diseases
Congenital Abnormalities