NCT07429188

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
11mo left

Started Feb 2026

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress28%
Feb 2026May 2027

First Submitted

Initial submission to the registry

February 10, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

February 12, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 24, 2026

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Expected
Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

Same day

First QC Date

February 10, 2026

Last Update Submit

February 17, 2026

Conditions

Keywords

Family caregiverupper limb assistance deviceuserprofessional caregiverCE-marked assistive devicemechanical arm supportselectric arm supportsrobotic armsgrasping glovesmealtime aids

Outcome Measures

Primary Outcomes (1)

  • 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 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)

    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)

    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).

    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.

    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.

    Clinical evaluation phase between Day 0 and Day 60."

  • +2 more secondary outcomes

Study Arms (5)

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

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.

electric arm supportsgrasping glovesmealtime aidsmechanical arm supportsrobotic arms

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Bouffard Vercelli

Perpignan, 66962, France

RECRUITING

Centre de Kerpape

Ploemeur, 56270, France

RECRUITING

MeSH Terms

Conditions

Spinal Cord InjuriesNeuromuscular DiseasesArthrogryposis

Interventions

Interviews as TopicSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesJoint DiseasesMusculoskeletal DiseasesMuscular DiseasesMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Charles FATTAL, Physician

    Centre Bouffard Vercelli

    PRINCIPAL INVESTIGATOR
  • Pauline COIGNARD, Physician

    Centre de Kerpape

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte LE GOFF, PhD Student

CONTACT

Charline LONGUET, CRA

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2026

First Posted

February 24, 2026

Study Start

February 12, 2026

Primary Completion

February 12, 2026

Study Completion (Estimated)

May 1, 2027

Last Updated

February 24, 2026

Record last verified: 2026-02

Locations