Impact Study on Users of Upper Limb Assistive Devices (AMUSE)

Impact Study on Users of Upper Limb Assistive Devices (AMUSE)

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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injury; Post-stroke; Arthrogryposis; Neuromuscular Disorders; Motor Impairment; User Experience; User of an Upper Limb Assistance Device
• Intervention / Treatment: Other: interviews and questionnaires

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Charlotte LE GOFF, PhD Student; Phone Number: +33 02.97.82.61.74; Email: association.approche56@gmail.com
• Study Contact Backup: Name: Charline LONGUET, CRA; Phone Number: +33 02.97.82.61.74; Email: charline.longuet@vyv3.fr

Study Locations

• France
  • Perpignan, France, 66962
    • Recruiting
    • Centre Bouffard Vercelli
  • Ploemeur, France, 56270
    • Recruiting
    • Centre de Kerpape

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
electric arm supports	Other: interviews and questionnaires; 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.
robotic arms	Other: interviews and questionnaires; 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.
grasping gloves	Other: interviews and questionnaires; 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.
mealtime aids	Other: interviews and questionnaires; 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.
mechanical arm supports	Other: interviews and questionnaires; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	12-item questionnaire. Eight items assess the degree of satisfaction with the technology (weight, durability, fit, ease of use, dimensions, effectiveness, safety). Four items assess the degree of satisfaction with the related services (provision procedure, professional services, follow-up, repair and maintenance). Sources of dissatisfaction are also identified. Items are rated on a 5-level ordinal scale ranging from "not satisfied at all" to "very satisfied." Total scores are obtained by calculating the mean of the item scores. Sources of dissatisfaction are reported qualitatively.	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)	Assessment at T1 only The assessment is conducted in five steps: Identification of occupational performance problems (interview).; Rating by the individual, on a 10-point ordinal scale, of the importance of the identified problems. 3 & 4. Selection by the client of the five most important problems to address, followed by self-evaluation, for each selected problem, of their current performance and their satisfaction with that performance, using 10-point ordinal scales. 5. Re-evaluation by the individual, after the intervention, of their levels of performance and satisfaction related to the problems identified in Step 1 (rating). The assessment results are recorded on a form provided in the kit. Part of the value of this measure lies in the difference between the scores obtained before the intervention and at the time of re-evaluation (Step 5).	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).	The EuroQoL 5D (EQ-5D) is a standardized instrument used to measure health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.	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.	The participant will be asked about the following aspects : the method of acquiring the device, the impact of this acquisition on their expenses, the financial assistance received for the acquisition, and the household income.	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.	A first quantitative component will measure the level of acceptance of the device. For this purpose, we will use the following questionnaire : Usefulness, Satisfaction and Ease of Use (USE) questionnaire in its short version, composed of 17 items.; 9 items from the extended Unified Theory of Acceptance and Use of Technology (UTAUT2). This two questionnaires use a 5-point Likert scale: A respondent who checks "1" is in complete disagreement with the statement and "7" fully agrees with the statement. Their questions are formulated as first-person statements. A second qualitative component will allow us to explore the implicit dimensions of device use. Its aim is to complement, illustrate, and characterize the acceptance data obtained quantitatively by accessing users' subjectivity and their lived experience with the device. This component consists of a semi-structured interview lasting approximately 60 minutes.	Clinical evaluation phase between Day 0 and Day 60."
Evaluate the effect of using an upper-limb movement assistance device on the mental and physical burden perceived by the caregiver (relative or professional) in daily life: Caregiver Burden Scale (ZARIT Scale).	The following questionnaire presents a list of statements describing the usual condition of people who have the daily responsibility of caring for someone else. The scale allows an assessment of this caregiving burden, ranging from mild to moderate to severe. After each statement, the caregiver indicates whether they experience this condition: 0 = never; = rarely; = sometimes; = quite often; = almost all the time	Clinical evaluation phase between Day 0 and Day 60.
Evaluate the degree of acceptance, by caregiver-users (relatives and/or professionals), of the use of an upper-limb movement assistance device by their relative/patient, and the effect of this use on the way they support their relative/patient.	A short version of the Usefulness, Satisfaction and Ease of Use (USE) questionnaire was adapted to be administered to caregiver-users. T 6 itemsfrom the extended Unified Theory of Acceptance and Use of Technology (UTAUT2). 5 items focusing on the patient-user's autonomy in relation to the use of the assistive device (installation, uninstallation, maintenance...). Then, a semi-structured interview (lasting approximately 60 minutes) will be conducted to evaluate the effect of the patient-user's use of the device on the caregiver-user's support. Its objective is to understand the use of the upper-limb assistance device within a systemic perspective, taking into account its social impact on individual and collective dynamics.	Clinical evaluation phase between Day 0 and Day 60.

Collaborators and Investigators

• Sponsor: Association APPROCHE
• Collaborators: Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape; Centre Bouffard Vercelli - USSAP; LP3C, University of Rennes 2; Université Lyon 2; ERPHAN; Ecole Nationale Supérieure Mines - Télécom Atlantique Bretagne Pays de la Loire. (IMT Atlantique - Bretagne - Pays de la Loire); Alternative Energies and Atomic Energy Commission (CEA); Université d'Artois
• Investigators: Principal Investigator: Charles FATTAL, Physician, Centre Bouffard Vercelli; Principal Investigator: Pauline COIGNARD, Physician, Centre de Kerpape

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2026
• Primary Completion (Actual): February 12, 2026
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: February 10, 2026
• First Submitted That Met QC Criteria: February 17, 2026
• First Posted (Actual): February 24, 2026

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Family caregiver; upper limb assistance device; user; professional caregiver; CE-marked assistive device; mechanical arm supports; electric arm supports; robotic arms; grasping gloves; mealtime aids
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Wounds and Injuries; Joint Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Trauma, Nervous System; Spinal Cord Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Spinal Cord Injuries; Arthrogryposis; Neuromuscular Diseases; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Interviews as Topic; Surveys and Questionnaires
• Other Study ID Numbers: 2025-A01577-42

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No