Impact Evaluation of Breizh Fabribus Intervention for Personalized Assistive Technology Creation or Adaptation

NCT ID: NCT07314099

Last Updated: 2026-01-02

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2026-11-30

Brief Summary

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.

Detailed Description

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.

Conditions

Amputation; Functional Limitation; Autonomy of Older People; Handicaps Physical; Autonomy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Any person who has received assistance from BFB for the creation or adaptation of assistive technology

Exclusion Criteria

• objection to the use of their data
• Sollicitation but no delivery of technical assistance by BFB

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fondation Ildys

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fondation ILDYS

Brest, Finistère, France

Site Status: RECRUITING

Countries

France

Central Contacts

Matthieu PICHELIN

Role: CONTACT

rcpromotion@ildys.org

02 98 02 11 36

Facility Contacts

VALLEE

Role: primary

0298293939

Other Identifiers

RI2025_004

Identifier Type: -

Identifier Source: org_study_id