Feasibility Study of a Digital Toolkit for Cerebral Palsy

  • Research type

    Research Study

  • Full title

    Feasibility Study to Evaluate a Digital Toolkit as a Means of Assessing the Effectiveness of Mobility Devices in Children with Cerebral Palsy

  • IRAS ID

    271491

  • Contact name

    Ian Cleland

  • Contact email

    i.cleland@ulster.ac.uk

  • Sponsor organisation

    Ulster University

  • Duration of Study in the UK

    1 years, 0 months, 30 days

  • Research summary

    Our research team are developing a Digital Toolkit to look at the effects of using different mobility devices for children with cerebral palsy. The Toolkit is made up of commercially available sensors which are able to detect body functions such as heart rate, breathing, how hard the muscles are working and how much the joints are moving. These are all useful measurements to know when deciding which mobility device is most suitable for a child. Usually, these measurements can only be made in a formal laboratory environment. However, because the sensors in the Toolkit can be used anywhere, they avoid the necessity of the laboratory.
    In this study, we take a look at how the Digital Toolkit performs when used with children with cerebral palsy. In particular, we want to know if our testing procedures work well and are safe, and what do the children and parents think of the testing procedures.
    Ten children with cerebral palsy, aged 6 to 16, will be recruited to the study. They will be identified by their physiotherapists. Those who agree to take part will attend Ulster University on two occasions over the course of a week and receive a follow-up phone call. Visit 1 will involve competing the informed consent, collecting some basic information, filling in some questionnaires and having a practice using the mobility devices and wearing the sensors. Visit 2 will involve the completion of different movement tasks while wearing the sensors, followed by a conversation with the child and carer regarding their perceptions of the testing procedures. The follow-up phone call with the parent/guardian will be used to ask if the child experienced any delayed effects of the testing procedures after Visit 2.

    Summary of Results

    The impact of COVID made recruitment and engagement of Children impossible.

    Emerging post COVID, challenges with continuity of funding and barriers to recruitment given continued disruption to Schools, led to the decision to abandon the project. Recruitment sites in NHS/HSC were notified at that time.

    Has the registry been updated to include summary results?: No
    If yes - please enter the URL to summary results:
    If no – why not?: The impact of COVID made recruitment and engagement of Children impossible.

    Emerging post COVID, challenges with continuity of funding and barriers to recruitment given continued disruption to Schools, led to the decision to abandon the project. Recruitment sites in NHS/HSC were notified at that time.

    There are no results to publish
    Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: No
    If yes, describe or provide URLs to disseminated materials:
    If pending, date when dissemination is expected:
    If no, explain why you didn't follow it: Due to COVID, participant where not recruited and therefore there are no further results to publish. A review about the technoilogy within the tool kit was published in Frontiers in Digital Health: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbTz8cxsQF9Zcn5jbmwy3NZcQvOgFUj8lxEQs89BqqqzoHJ5qQzDYfq9z91XeTGwfMLQBVsxehlJPufsb9nenHDfJ2R1Q522Z-2BHmsnb9-2B6-2BAAWZFPgq-2Fp2S94iiT9CwNgfA-3D-3DoJJP_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YIWp8mU2rInax0hepNJ2gyy0UcdtxYrITqeI5uOqqIKvoFg6KeuVqTLLfotBMTexqyxoWCEnAaq9aOrj3FoaC60BWieJ3HqdWLZWdOdRU5hykhOkFFEyGU-2B8lv-2FGFBBMiBtdx7E3K25oQNFanr0zRa-2BVjXSVZO-2FJISFCA-2BWl7adZA-3D-3D&data=05%7C02%7Cstanmore.rec%40hra.nhs.uk%7C82315221ced540b7891608dc273dd6ac%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638428393745995808%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=8luQI6Bzjzb6kj%2B%2FVQpn906HFMkpZ8nINoaJapMtnTg%3D&reserved=0
    Have participants been informed of the results of the study?: No
    If yes, describe and/or provide URLs to materials shared and how they were shared:
    If pending, date when feedback is expected:
    If no, explain why they haven't: No participants where recruited
    Have you enabled sharing of study data with others?: No
    If yes, describe or provide URLs to how it has been shared:
    If no, explain why sharing hasn't been enabled: No particpants where recruited therefore there is no data to share.
    Have you enabled sharing of tissue samples and associated data with others?: No
    If yes, describe or provide a URL:
    If no, explain why: No particpants whererecruited therefore there is no data to share.

  • REC name

    London - Stanmore Research Ethics Committee

  • REC reference

    20/HRA/2270

  • Date of REC Opinion

    1 Jun 2020

  • REC opinion

    Further Information Favourable Opinion