AmputationBFB-IMPACTNCT07314099
Impact Evaluation of Breizh Fabribus Intervention for Personalized Assistive Technology Creation or Adaptation
An observational study of Amputation and Functional Limitation, run by Fondation Ildys at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Amputation, Functional Limitation, Autonomy of Older People
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2025to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants are Finistère's habitants, and have received help and creation from BFB.
Who may be able to join
- Any person who has received assistance from BFB for the creation or adaptation of assistive technology
Who cannot join
- objection to the use of their data
- Sollicitation but no delivery of technical assistance by BFB
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Fondation ILDYS
Brest, Finistère, 29200
VALLEE, 0298293939
About this study
Official title: Évaluation d'Impact de l'Intervention du Breizh Fabribus Pour la création ou l'Adaptation d'Aide Technique personnalisée (BFB-IMPACT)
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.
Read the 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.
- Keywords
- mobile workshop, 3D printing, laser cutting, personalized devices, user satisfaction, functionnal autonomy, disability
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Three months following delivery of the personalized assistive device.
Secondary outcomes (5)
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.
Measured: 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).
Measured: Three months post-intervention
Barriers to Device Utilization
Open-ended responses analyzed for reported barriers to use. Qualitative analysis.
Measured: 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.
Measured: Three months post-intervention.
Reasons for Requesting the Assistive Device
Qualitative coding of motivations as reported by participants at intake.
Measured: At baseline (device request/intake).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study startDec 2025 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Ildys
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07314099
- Sponsor's protocol ID
- RI2025_004
- Acronym
- BFB-IMPACT
- Status last verified
- Dec 2025
- First submitted
- 17 Dec 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Évaluation d'Impact de l'Intervention du Breizh Fabribus Pour la création ou l'Adaptation d'Aide Technique personnalisée (BFB-IMPACT)
- ClinicalTrials.gov ID
- NCT07314099
- Acronym / sponsor ID
- BFB-IMPACT / RI2025_004
- Keywords
- mobile workshop, 3D printing, laser cutting, personalized devices, user satisfaction, functionnal autonomy, disability
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Fondation IldysUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants are Finistère's habitants, and have received help and creation from BFB.
Key inclusion criteria (1 listed)
- Any person who has received assistance from BFB for the creation or adaptation of assistive technology
Key exclusion criteria (2 listed)
- objection to the use of their data
- Sollicitation but no delivery of technical assistance by BFB
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in frequency of exposure to the index activity limitation at three months post-intervention
Time frame: Three months following delivery of the personalized assistive device.
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.
5 secondary outcomes
Satisfaction with the Assistive Device
Time frame: At device delivery and three months post-intervention.
Frequency of Device Use
Time frame: Three months post-intervention
Barriers to Device Utilization
Time frame: Three months post-intervention.
Influence of Sociodemographic Factors
Time frame: Three months post-intervention.
Reasons for Requesting the Assistive Device
Time frame: At baseline (device request/intake).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amputation and Functional Limitation, run by Fondation Ildys at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthieu PICHELIN (02 98 02 11 36, rcpromotion@ildys.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in frequency of exposure to the index activity limitation at three months post-intervention (time frame: Three months following delivery of the personalized assistive device.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.