ChildrenNCT02682043
Parental Perspectives of Using Toy Cars on Social Interactions of Preschool Children With Mobility Impairments
A study testing Toy car in people with Children and Mobility Limitation, run by University of Ulster.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 47 monthsHealthy volunteers can take part
- Conditions the study is for
- Children, Mobility Limitation, Spina Bifida
- What is being tested?
- Toy car
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 47 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
Read the 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.
- Conditions
- Children, Mobility Limitation, Spina Bifida, Attitude to Health
- Being tested
- Toy car
- Medical subject headings
- Mobility Limitation, Spinal Dysraphism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toy carDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Toy car | Experimental | 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. Receives: Device: Toy car |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent Interview
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.
Measured: on completion of 8 week trial
Secondary outcomes (1)
Psychosocial Impact of Assistive Devices Scale (PIADS) - Jutai & Day 2002
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.
Measured: Baseline and on completion of 8 week trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionJun 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- Belfast Health and Social Care Trust
- Responsible party
- Sponsor
- Investigators
- Jackie Casey, MSc, Study chair, University of UlsterLaura McKeown, PhD, Study chair, University of Ulster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02682043
- Sponsor's protocol ID
- 15/0131
- Status last verified
- Sep 2016
- First submitted
- 26 Jan 2016
- Last updated
- 9 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: On completion of study - data will be analyzed and disseminated through paper/ conference presentations. All data will be anonymized.
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parental Perspectives of Using Modified Toy Cars on the Social Interactions of Preschool Children With Mobility Impairments.
- ClinicalTrials.gov ID
- NCT02682043
- Acronym / sponsor ID
- 15/0131
- Conditions
- Children, Mobility Limitation, Spina Bifida, Attitude to Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- Belfast Health and Social Care Trust
- Study start
- Feb 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 15 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Toy car | Experimental | Device: Toy carThe 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. |
Who may qualify
- Ages
- 12 to 47 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toy carThe 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. | Device | Toy car |
Primary outcome
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.
1 secondary outcome
Psychosocial Impact of Assistive Devices Scale (PIADS) - Jutai & Day 2002
Time frame: Baseline and on completion of 8 week trial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2016.
- Individual participant dataSharing planned: Yes. On completion of study - data will be analyzed and disseminated through paper/ conference presentations. All data will be anonymized.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jackie Casey, MSc study chair
University of Ulster
Laura McKeown, PhD study chair
University of Ulster
Questions about this trial
What is this clinical trial studying?
A study testing Toy car in people with Children and Mobility Limitation, run by University of Ulster.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent Interview (time frame: on completion of 8 week trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2016.