Impact Study on Users of Upper Limb Assistive Devices

Association APPROCHE150 enrolled

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.

Study Type

OBSERVATIONAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Enrollment phase : Day 0

Secondary Outcomes

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.

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)

Assessment at T1 only The assessment is conducted in five steps: 1. Identification of occupational performance problems (interview). 2. 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).