How upper-limb assistive devices affect users' daily life

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.