Impact Study on Users of Upper Limb Assistive Devices

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssociation APPROCHE

About this trial

This impact study of upper limb (UL) assistance devices is part of the Exploratory PEPR O2R "Robotic assistance for human movements." The integrated project PI3 "ASSISTMOV," composed of a multidisciplinary team in engineering and Human and Social Sciences (HSS), targets the use case of employing robotic assistance for the movement of persons with disabilities (PWD). Through the development of a range of exoskeletons (lower and upper limbs), this project aims for a breakthrough technology enabling fluid and robust interaction with a variety of environments and uses (from rehabilitation to daily life).

The proposed study contributes to this objective by exploring the clinical and psychosocial dimensions of the daily use of UL assistance devices. Through interviews and questionnaires, it aims to collect data on their impact in terms of independence in activities of daily living (ADL), satisfaction, quality of life, social participation, as well as social perceptions related to the use of these technical aids. It will make it possible to document the benefits and limitations of existing devices from the users' point of view (patients and informal and/or professional caregivers), by identifying the factors that facilitate or hinder their adoption and by exploring the care pathway, from prescription to daily use. The questionnaires will also allow examination of economic dimensions.

The participants included in this study will be recruited among users already using, in their daily life, an UL movement assistance device. All will be regular users of their device, functionally integrated into their usual environment for at least two months. Only devices benefiting from CE marking, guaranteeing their compliance with European regulations, will be eligible. No equipment will be specifically provided within the framework of this research: each participant will share their experience with their own device, as it is integrated into their ADL. A preliminary literature review helped identify the main categories of UL movement assistance devices, grouped according to the following typologies: grasping gloves, mealtime aids, robotic manipulation arms, and arm supports (electric or mechanical).

The purpose of the approach is both diagnostic and forward-looking. It is diagnostic in that it makes it possible to analyze current practices, real activity, and users' viewpoints, in order to identify elements likely to be improved in the recommendation and use of the devices. It is also forward-looking, since it aims to identify new opportunities, needs, or potential developments, in order to support the thinking of roboticists based on field observations.

Eligibility criteria

Qualifiers

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

Disqualifiers

Participant enrolled in another protocol evaluating a technical aid

Insufficient mastery of the French language

Insufficient mastery of the French language

Cognitive impairments preventing understanding of the questions

Trial design

Treatments tested in this trial

  • interviews and questionnaires

Treatment groups

150 Participants
are divided into 5 treatment groups

Sponsors and collaborators

Association APPROCHE

Lead sponsor

Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape

Collaborator

University of Rennes 2

Collaborator

ERPHAN

Collaborator

Ecole Nationale Supérieure Mines - Télécom Atlantique Bretagne Pays de la Loire. (IMT Atlantique - Bretagne - Pays de la Loire)

Collaborator

Alternative Energies and Atomic Energy Commission (CEA)

Collaborator

Centre Bouffard Vercelli - USSAP

Collaborator

Université Lyon 2

Collaborator

University of Artois

Collaborator