Impact Study on Users of Upper Limb Assistive Devices

Official title

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

Overview

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.

Interventions

• 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.

Primary outcome measures

• 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). [Time frame: Enrollment phase : Day 0]

Secondary outcome measures (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) [Time frame: 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) [Time frame: 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). [Time frame: 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. [Time frame: 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. [Time frame: 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). [Time frame: 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. [Time frame: Clinical evaluation phase between Day 0 and Day 60.]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

France · 2 centers

• Centre Bouffard Vercelli — Perpignan
• Centre de Kerpape — Ploemeur

Identifiers

NCT: NCT07429188 · 2025-A01577-42

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗