User of an Upper Limb Assistance DeviceAMUSENCT07429188
Impact Study on Users of Upper Limb Assistive Devices
An observational study of User of an Upper Limb Assistance Device and User Experience, run by Association APPROCHE at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- User of an Upper Limb Assistance Device, User Experience, Post-stroke
- What is being tested?
- interviews and questionnaires
- How many people
- 150 participants
- Where
- 2 sitesFrance
- Study dates
- 12 Feb 2026to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Centre Bouffard Vercelli
Perpignan, 66962
- Recruiting
Centre de Kerpape
Ploemeur, 56270
About this study
Official title: 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.
Read more
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.
- Conditions
- User of an Upper Limb Assistance Device, User Experience, Post-stroke, Spinal Cord Injury, Neuromuscular Disorders, Arthrogryposis
- Being tested
- interviews and questionnaires
- 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
- Medical subject headings
- Spinal Cord Injuries, Neuromuscular Diseases, Arthrogryposis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interviews and questionnairesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| electric arm supports | Not described Receives: Other: interviews and questionnaires | |
| robotic arms | Not described Receives: Other: interviews and questionnaires | |
| grasping gloves | Not described Receives: Other: interviews and questionnaires | |
| mealtime aids | Not described Receives: Other: interviews and questionnaires | |
| mechanical arm supports | Not described Receives: Other: interviews and questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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.
- 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Clinical evaluation phase between Day 0 and Day 60.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start12 Feb 2026
- Primary completion12 Feb 2026
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for User of an Upper Limb Assistance DeviceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association APPROCHE
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape, 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, University of Artois
- Responsible party
- Sponsor
- Investigators
- Charles FATTAL, Physician, Principal investigator, Centre Bouffard VercelliPauline COIGNARD, Physician, Principal investigator, Centre de Kerpape
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07429188
- Sponsor's protocol ID
- 2025-A01577-42
- Acronym
- AMUSE
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Study on Users of Upper Limb Assistive Devices (AMUSE)
- ClinicalTrials.gov ID
- NCT07429188
- Acronym / sponsor ID
- AMUSE / 2025-A01577-42
- Conditions
- User of an Upper Limb Assistance Device, User Experience, Post-stroke, Spinal Cord Injury, Neuromuscular Disorders, Arthrogryposis
- Keywords
- Family caregiver, upper limb assistance device, user, professional caregiver, CE-marked assistive device, mechanical arm supports, electric arm supports, robotic arms
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Association APPROCHEUniversity, hospital or other
- Collaborators
- Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape, 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, University of Artois
- Study start
- 12 Feb 2026 (actual)
- Primary completion
- 12 Feb 2026 (actual)
- Study completion
- May 2027 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| electric arm supports | – | Other: interviews and questionnaires |
| robotic arms | – | Other: interviews and questionnaires |
| grasping gloves | – | Other: interviews and questionnaires |
| mealtime aids | – | Other: interviews and questionnaires |
| mechanical arm supports | – | Other: interviews and questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interviews and questionnairesThrough 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. | Other | electric arm supports, grasping gloves, mealtime aids, mechanical arm supports, robotic arms |
Primary outcome
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
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.
7 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)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charles FATTAL, Physician principal investigator
Centre Bouffard Vercelli
Pauline COIGNARD, Physician principal investigator
Centre de Kerpape
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of User of an Upper Limb Assistance Device and User Experience, run by Association APPROCHE at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charlotte LE GOFF, PhD Student (02.97.82.61.74 ext. +33, association.approche56@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.