Impact Study on Users of Upper Limb Assistive Devices
AMUSE
1 other identifier
observational
150
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2026
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2026
CompletedStudy Start
First participant enrolled
February 12, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 12, 2026
CompletedFirst Posted
Study publicly available on registry
February 24, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
ExpectedFebruary 24, 2026
February 1, 2026
Same day
February 10, 2026
February 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate the psychosocial impact of using an upper-limb movement assistance device in daily life, as perceived by the patient-user: French-Quebec version of the Psychosocial Impact of Assistive Devices Scale (F-PIADS).
This scale consists of 26 items, each rated from -3 to 3. Each item is a word or phrase attempting to describe how the use of an assistive device may influence the user. A score of -3 indicates that the assistive device decreases the aspect described by the item, whereas a score of 3 indicates that it increases it.
Enrollment phase : Day 0
Secondary Outcomes (7)
Evaluate the satisfaction regarding the use of the upper-limb assistance device in daily life, as perceived by the patient-user : Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)
Enrollment phase : Day 0
Explore the priorities of use of the upper-limb movement assistance device reported by the patient-user in daily life: Canadian Occupational Performance Measure (COPM)
Clinical evaluation phase between Day 0 and Day 60.
Measure the quality of life in users of upper-limb movement assistance devices: EuroQoL 5D (EQ-5D-5L).
Clinical evaluation phase between Day 0 and Day 60.
Evaluate the impact of the integration of an upper-limb movement assistance device on resources and associated costs through medico-economic items specifically developed for the study.
Clinical evaluation phase between Day 0 and Day 60.
Evaluate the acceptance of an upper-limb movement assistance device and its facilitating effect on activities of daily living through semi-structured interviews.
Clinical evaluation phase between Day 0 and Day 60."
- +2 more secondary outcomes
Study Arms (5)
electric arm supports
robotic arms
grasping gloves
mealtime aids
mechanical arm supports
Interventions
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 on the social perceptions related to the use of these assistive devices.
Eligibility Criteria
Patient-users: persons with motor disabilities (post-stroke, spinal cord injury, neuromuscular disorders, arthrogryposis, etc.), users of upper-limb movement assistance devices. Caregiver-users: persons living with or regularly interacting with the patient-user (relatives and/or professionals).
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Association APPROCHElead
- Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpapecollaborator
- LP3C, University of Rennes 2collaborator
- ERPHANcollaborator
- 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 - USSAPcollaborator
- Université Lyon 2collaborator
- Université d'Artoiscollaborator
Study Sites (2)
Centre Bouffard Vercelli
Perpignan, 66962, France
Centre de Kerpape
Ploemeur, 56270, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charles FATTAL, Physician
Centre Bouffard Vercelli
- PRINCIPAL INVESTIGATOR
Pauline COIGNARD, Physician
Centre de Kerpape
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2026
First Posted
February 24, 2026
Study Start
February 12, 2026
Primary Completion
February 12, 2026
Study Completion (Estimated)
May 1, 2027
Last Updated
February 24, 2026
Record last verified: 2026-02