Impact Evaluation of Breizh Fabribus Intervention for Personalized Assistive Technology Creation or Adaptation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorFondation Ildys
About this trial
In France, more than 14 million individuals report severe functional limitations, and nearly 5 million struggle with essential daily activities. Traditional barriers to assistive technology-high costs, lengthy funding delays, lack of information, and poorly fitting off-the-shelf solutions-frequently lead to underuse, dissatisfaction, and environmental waste The BFB-IMPACT study evaluates the real-world effectiveness of Breizh Fabribus, a mobile workshop equipped with 3D printing and laser-cutting that produces and customizes assistive devices on site for people with disabilities in Finistère, France region. This retrospective, single-center investigation includes all service recipients from January 2024 to December 2025 and measures changes in users' ability to perform targeted activities at three months post-intervention. Secondary outcomes include user satisfaction and device utilization. Data collection occurs from October 2025 to May 2026, with analysis anticipated in June 2026 and results published in the second half of 2026.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Any person who has received assistance from BFB for the creation or adaptation of assistive technology
Disqualifiers
objection to the use of their data
Sollicitation but no delivery of technical assistance by BFB
Trial population
Participants are Finistère's habitants, and have received help and creation from BFB.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Change in frequency of exposure to the index activity limitation at three months post-intervention
Change in the frequency with which participants encounter their initial activity limitation, measured via a standardized 5-point ordinal scale at baseline and at three months post-intervention. On this scale, 1 represents "never exposed to the activity limitation" and 5 indicates "exposed every day." Lower scores correspond to less frequent difficulty, while higher scores reflect more frequent difficulty with the targeted activity. This outcome assesses the impact of the personalized assistive device provided by Breizh Fabribus.
Time frame
Three months following delivery of the personalized assistive device.Secondary outcomes
1
Satisfaction with the Assistive Device
Participant satisfaction measured by the Client Satisfaction Questionnaire (CSQ-8: range 8-32, higher scores indicate greater satisfaction) at delivery and by the ESAT Satisfaction Scale (range: 0-10, higher scores indicate greater satisfaction) at three months.
Time frame
At device delivery and three months post-intervention.2
Frequency of Device Use
Self-reported frequency of use in the targeted activity, measured using a 5-point Device Use Frequency Scale (1 = never, 5 = every day; higher values indicate more frequent use).
Time frame
Three months post-intervention3
Barriers to Device Utilization
Open-ended responses analyzed for reported barriers to use. Qualitative analysis.
Time frame
Three months post-intervention.4
Influence of Sociodemographic Factors
Analysis of association between demographic characteristics and outcome measures based on CSQ-8, ESAT, and Device Use Frequency Scale.
Time frame
Three months post-intervention.Other outcomes
1
Satisfaction with the Assistive Device (12 Months)
Participant satisfaction assessed using the ESAT Satisfaction Scale (range: 0-10, higher scores indicate greater satisfaction) at twelve months post-intervention.
Time frame
Twelve months post-intervention.2
Frequency of Device Use (12 Months)
Self-reported frequency of use in the targeted activity, measured using the 5-point Device Use Frequency Scale (1 = never, 5 = every day; higher scores indicate more frequent use) at twelve months.
Time frame
Twelve months post-intervention.3
Barriers to Device Utilization (12 Months)
Open-ended responses analyzed for reported barriers to use of the assistive device, assessed at twelve months post-intervention, qualitative data only.
Time frame
Twelve months post-intervention.4
Change in Exposure to Activity Limitation (12 Months)
Change in the frequency with which participants encounter the initial activity limitation, measured via a standardized 5-point ordinal scale (1 = never, 5 = every day) at baseline and twelve months post-intervention.
Time frame
Twelve months post-intervention.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov