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

NCT07314099 | Recruiting

• 1 other identifier: RI2025_004
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

mobile workshop; 3D printing; laser cutting; personalized devices; user satisfaction; functionnal autonomy; disability

Outcome Measures

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.

  Three months following delivery of the personalized assistive device.

Secondary Outcomes (5)

• Satisfaction with the Assistive Device

  At device delivery and three months post-intervention.

• Frequency of Device Use

  Three months post-intervention

• Barriers to Device Utilization

  Three months post-intervention.

• Influence of Sociodemographic Factors

  Three months post-intervention.

• Reasons for Requesting the Assistive Device

  At baseline (device request/intake).

Other Outcomes (4)

• Satisfaction with the Assistive Device (12 Months)

  Twelve months post-intervention.

• Frequency of Device Use (12 Months)

  Twelve months post-intervention.

• Barriers to Device Utilization (12 Months)

  Twelve months post-intervention.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants are Finistère's habitants, and have received help and creation from BFB.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fondation Ildys: lead

Study Sites (1)

Fondation ILDYS

Brest, Finistère, 29200, France

RECRUITING

Central Study Contacts

Matthieu PICHELIN

CONTACT

02 98 02 11 36; rcpromotion@ildys.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: January 2, 2026
• Study Start: December 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

FR (1)