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Proof-of-concept Study of 'JIA Toolbox' for Children and Young People (CYP) With Juvenile Idiopathic Arthritis (JIA)

NCT05563194 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-06-08

No results posted yet for this study

Summary

This project aims to further develop and conduct a 'real-world' proof-of-concept assessment of a suite of three products, known as the 'JIA Toolbox', that collectively aim to improve CYP's independence and functional ability

'JIA Toolbox' targets key unmet needs identified by stakeholders during our previous work. Each prototype (Appendix1) addresses a specific unmet need:

1. Prototype-1: Pain which stops CYP doing the things they love;
2. Prototype-2: Difficulty for healthcare professionals (HCPs) to motivate CYP to do stretches;
3. Prototype-3: Communication difficulties between teachers and CYP

The project is at a stage where the prototypes need their potential value assessed through a proof-of-concept study. A co-design approach, involving CYP with JIA, their parents, their teachers and HCPs, will be maintained throughout to ensure the outcomes are meaningful. This study will begin with co-design workshops to develop the current prototypes further, followed by a qualitative study assessing the real-world usability, acceptability and potential impacts of these prototypes; testing them with real users in their homes. The project aims to make a positive contribution to CYP with JIA by improving their independence and functional ability through co-designed therapeutic interventions.

Conditions

  • Rheumatologic Disease

Interventions

DEVICE

Heating prototype (Prototype 1)

A wearable that heats and vibrates to help distract from pain. It can be wrapped around any joint with temperature and vibration settings allowing CYP to set the device to their needs.

DEVICE

Physio tool (Prototype 2)

A motivational physiotherapy tool that incrementally lights up as the CYP do their prescribed stretches, emphasising a sense of progression and making it a more engaging activity.

DEVICE

Communication tool (Prototype 3)

A wearable to help communication in the classroom between the teacher and pupil. The child can alert the teacher if they need help, through vibration, without attracting the attention of their classmates, reducing embarrassment.

Sponsors & Collaborators

  • Sheffield Children's NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Ursula Ankeny · Sheffiled Hallam University

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-15
Primary Completion
2023-02-15
Completion
2023-03-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05563194 on ClinicalTrials.gov