Viewing Study NCT06552819



Ignite Creation Date: 2024-10-26 @ 3:37 PM
Last Modification Date: 2024-10-26 @ 3:37 PM
Study NCT ID: NCT06552819
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-08-06

Brief Title: User Experience of a Gait Training Treadmill for Home Rehabilitation of Children With Chronic Conditions
Sponsor: None
Organization: None

Study Overview

Official Title: User Experience of a Gait Training Treadmill for Home Rehabilitation of Children With Chronic Conditions
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: EMMVIES-UX
Brief Summary: In the context of limited accessibility to prolonged and efficient rehabilitation programs based on physical activity this study aims to develop a home program for children with chronic diseases affecting physical health including cerebral palsy obesity and neuromuscular diseases The French company EzyGain has designed a compact treadmill equipped with sensors and a safety system which communicates with a tablet application and a virtual reality headset to support at-home rehabilitation This study seeks to advance the development of this solution into a prolonged and progressive training program tailored to positively impact childrens health Future users including children their parents and therapists will be at the heart of the development process A qualitative methodology will be employed incorporating focus groups and a series of user experience UX questionnaires The research hypothesis is that user feedbacks will enable the development of an appropriate solution that meets their specific needs and ensures high adoption rates of the device

This study is the first step before assessing the impact of the solution in these 3 groups of children with cerebral palsy obesity and neuromuscular disease
Detailed Description: Visit 1 Children accompanied by one of their parents will test the treadmill and the associated rehabilitation games on a tablet and in immersive virtual reality in its current version and UX questionnaires will be administered

Visit 2 Children parents and therapists in groups of 6 to 8 will participate in focus groups during which they will express their opinions regarding the solution they tested in Visit 1 and discuss areas for improvement

several monthsare dedicated to the developpement of the solution by the society based on the children parents and therapists feedbacks

Visit 3 Children accompanied by one of their parents will test the treadmill and the associated rehabilitation games on a tablet and in immersive virtual reality in its new version and UX questionnaires will be administered

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None