How upper-limb assistive devices affect users' daily life
Impact Study on Users of Upper Limb Assistive Devices (AMUSE)
Association APPROCHE · NCT07429188
This project will see if using a CE-marked upper-limb assistive device helps adults with stroke, spinal cord injury, or neuromuscular disorders improve independence, satisfaction, and social participation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Association APPROCHE (other) |
| Locations | 2 sites (Perpignan and 1 other locations) |
| Trial ID | NCT07429188 on ClinicalTrials.gov |
What this trial studies
This observational study combines interviews and standardized questionnaires with adult users of CE-marked upper-limb assistive devices and their caregivers to document clinical and psychosocial impacts in daily life. Participants must have used their device for at least 60 days, be medically stable, and be able to complete remote videoconference interviews and online questionnaires. Data collected will cover independence in activities of daily living, device satisfaction, quality of life, social participation, and social perceptions related to device use. The project is embedded in a wider engineering and human/social sciences program developing exoskeletons and aims to provide real-world user-centered evidence to guide design and deployment.
Who should consider this trial
Good fit: Adults (≥18) who are medically stable, cognitively able to complete interviews and questionnaires, have used a CE-marked upper-limb assistance device for at least 60 days, and can participate in videoconference sessions.
Not a fit: People with acute medical events, severe cognitive impairment, insufficient device experience (<60 days), or currently enrolled in another technical-aid protocol are unlikely to benefit from the study's findings.
Why it matters
Potential benefit: If successful, the findings could guide device design, clinical guidance, and support services to increase users' independence, satisfaction, and social participation.
How similar studies have performed: Prior small observational and pilot studies have reported improvements in function and user satisfaction with some upper-limb assistive devices, but large real-world evidence on daily-life psychosocial impact remains limited and mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: FOR PATIENT-USER : * Age ≥ 18 years * Effective use of a CE-marked upper-limb assistance device for at least 60 days * Access to a computer with an internet connection and ability to participate in a videoconference * Having provided free and informed non-opposition, or, where applicable, their legal representative * Cognitive abilities compatible with completing the questionnaires and interviews * Medically stable (no ongoing medical event likely to affect the proper conduct of the study) FOR CAREGIVER-USERS (RELATIVES AND/OR PROFESSIONALS) : * Age ≥ 18 years * Relatives or professionals living with or regularly interacting with the patient-user of an upper-limb assistance device * Access to a computer with an internet connection and ability to participate in a videoconference * Having provided free and informed non-opposition Exclusion Criteria: FOR PATIENT-USER : * Participant enrolled in another protocol evaluating a technical aid * Insufficient mastery of the French language FOR CAREGIVER-USERS (RELATIVES AND/OR PROFESSIONALS) * Insufficient mastery of the French language * Cognitive impairments preventing understanding of the questions
Where this trial is running
Perpignan and 1 other locations
- Centre Bouffard Vercelli — Perpignan, France (RECRUITING)
- Centre de Kerpape — Ploemeur, France (RECRUITING)
Study contacts
- Principal investigator: Charles FATTAL, Physician — Centre Bouffard Vercelli
- Study coordinator: Charlotte LE GOFF, PhD Student
- Email: association.approche56@gmail.com
- Phone: 02.97.82.61.74
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: User of an Upper Limb Assistance Device, User Experience, Post-stroke, Spinal Cord Injury, Neuromuscular Disorders, Arthrogryposis, Motor Impairment, Family caregiver