NCT02682043

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2016

Completed
6 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 15, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

November 9, 2016

Status Verified

September 1, 2016

Enrollment Period

4 months

First QC Date

January 26, 2016

Last Update Submit

November 8, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    on completion of 8 week trial

Secondary Outcomes (1)

  • Psychosocial Impact of Assistive Devices Scale (PIADS) - Jutai & Day 2002

    Baseline and on completion of 8 week trial

Study Arms (1)

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.

Device: Toy car

Interventions

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.

Toy car

Eligibility Criteria

Age12 Months - 47 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Mobility LimitationSpinal Dysraphism

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsNeural Tube DefectsNervous System MalformationsNervous System DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Jackie Casey, MSc

    University of Ulster

    STUDY CHAIR
  • Laura McKeown, PhD

    University of Ulster

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2016

First Posted

February 15, 2016

Study Start

February 1, 2016

Primary Completion

June 1, 2016

Study Completion

September 1, 2016

Last Updated

November 9, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will share

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