Arthrogryposis, Motor Impairment, Neuromuscular Disorders, Post-stroke, Spinal Cord Injury, User Experience, User of an Upper Limb Assistance Device
Conditions
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
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.
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.
Sponsors
Association APPROCHE
Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape
LP3C, University of Rennes 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)
Centre Bouffard Vercelli - USSAP
Université Lyon 2
Université d'Artois
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | Enrollment phase : Day 0 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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. | 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). |
| 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. | 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. |
| 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. | 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. |
| 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." | 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. |
| 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). | Clinical evaluation phase between Day 0 and Day 60. | 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 1. = rarely 2. = sometimes 3. = quite often 4. = almost all the time |
| 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. | Clinical evaluation phase between Day 0 and Day 60. | 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. |
Countries
France
Contacts
CONTACTCharlotte LE GOFF, PhD Student
CONTACTCharline LONGUET, CRA
PRINCIPAL_INVESTIGATORCharles FATTAL, Physician
Centre Bouffard Vercelli
PRINCIPAL_INVESTIGATORPauline COIGNARD, Physician
Centre de Kerpape
Outcome results
None listed