An observational study in Amputation, Functional Limitation and Autonomy of Older People, sponsored by Fondation Ildys. Recruiting at 1 site in France. Per ClinicalTrials.gov, last updated 2026-01-02.
Sponsored by Fondation Ildys · Observational
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.
The BFB-IMPACT protocol is a retrospective, mixed-methods study designed to assess Breizh Fabribus's impact on daily functioning and satisfaction among people with disabilities. All individuals who received at least one assistive device from Breizh Fabribus between January 1, 2024, and December 31, 2025, are identified via routine service records. Eligible participants and their caregivers are contacted by phone or mail and provided with study information and a consent form. Upon consent, baseline data-including demographics, medical history, and the nature of the activity difficulty-are extracted from initial request forms.
At the time of device delivery, each participant completes the Client Satisfaction Questionnaire (CSQ-8) to capture immediate feedback on device fit, usability, and co-creation experience. Three months later, participants receive a standardized follow-up questionnaire addressing: frequency of device use; changes in exposure to the originally problematic activity, rated on a five-point ordinal scale; satisfaction with device performance; and open-ended comments on barriers or facilitators. Data collection is conducted via secure online surveys or postal forms, with up to two reminders for nonresponders. An optional twelve-month follow-up is offered within the scheduled data-collection window (October 2025-May 2026) to explore longer-term durability of benefits.
The primary endpoint compares baseline and three-month follow-up scores on the activity exposure scale using paired statistical tests. Secondary analyses include trends in satisfaction scores, logistic regression to identify predictors of device adoption, and inductive content analysis of open-text feedback.
Data collection concludes in May 2026. Analysis is planned for June 2026, followed by manuscript preparation and dissemination to stakeholders in the second half of 2026. Continuous monitoring by the study coordinator ensures protocol adherence, timely follow-up, and resolution of any deviations.
Fondation Ildys is the lead sponsor of 15 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants are Finistère's habitants, and have received help and creation from BFB.
Exclusion Criteria:
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.
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.
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-intervention
Barriers to Device Utilization
Open-ended responses analyzed for reported barriers to use. Qualitative analysis.
Time frame: Three months post-intervention.
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.
Reasons for Requesting the Assistive Device
Qualitative coding of motivations as reported by participants at intake.
Time frame: At baseline (device request/intake).
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.
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.
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.
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.
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