User Experience of a Gait Training Treadmill for Home Rehabilitation of Children With Chronic Conditions

NCT06552819 | Not Yet Recruiting

• 1 other identifier: 49RC24_0261
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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 children's 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)."

Conditions

Chronic Diseases in Children

Keywords

User experience, home program, treadmill, virtual reality

Outcome Measures

Primary Outcomes (1)

• Focus group outputs

  List of topics addressed during the focus groups by patients, parents, and therapists. The topics will include: the needs and expectations of an at-home rehabilitation tool including virtual reality, perceived barriers and facilitators, and acceptability related to certain features of the solution.

  Between the second and third week

Secondary Outcomes (6)

• User Experience Questionnaire (UEQ-S)

  Day 1 and 6 months

• Usability Metric for User Experience (UMUX)

  Day 1 and 6 months

• Ease with technology

  Day 1 and 6 months

• Cybersickness

  Day 1 and 6 months

• Children's perception of the games

  Day 1 and 6 months

Study Arms (1)

Children with cerebral palsy, obesity and neuromuscular disease, parents and therapists

Other: No intervention

Interventions

No intervention OTHER

No intervention

Children with cerebral palsy, obesity and neuromuscular disease, parents and therapists

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients and parents from the active lists of medical doctors of the structures involved in the project. Therapists of the structures involved in the project.

You may qualify if:

• aged between 8 and 18 years old
• capable of walking during 5 minutes on a treadmill with or without walking aid, and with or without body weight support
• diagnosis of one the following pathology: bilateral cerebral palsy, obesity, spinal muscular amiotrophy type 3, Duchenne, congenital myopathy, Charcot Marie Tooth
• Gross Motor Function Classification System (GMFCS) I to III for the children with cerebral palsy
• IMC superior to the centile IOTF-30 for the children with obesity
• Functionnal level of 2 to 6 on the Walton scale, or 3 to 7 on the Vignos scale for the children with neuromuscular disease
• \- parent of an eligible child
• \- Therapist of at least one eligible child
• Able to express oneself and respond to a questionnaire in French
• Formulate their non-opposition to participate in the research

You may not qualify if:

• Deprived of liberty by judicial or administrative decision
• Subject to a legal protection measure"

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

CHU Angers

Angers, Maine Et Loire, 49100, France

Location

Central Study Contacts

Lena CARCREFF

CONTACT

+ 33 2 41 35 50 30; lena.carcreff@chu-angers.fr

Baptiste CHUPIN

CONTACT

+ 33 6 62 80 56 40; baptiste.chupin@chu-angers.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 14, 2024
• Study Start: September 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: May 1, 2025
• Last Updated: August 14, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)