Lower Limb Amputation Above Knee (Injury)INCREMENTNCT06635655
Assessment of the Prosthetic System Impact on Mental Workload in Above-knee Lower Limb Amputees.
An observational study of Lower Limb Amputation Above Knee (Injury), run by Proteor Group at 1 site in France.
Trial summary
New generation of lower limb prosthesis provide improved functionalities. They are usually studied in the scope of biomechanics, sometimes PROMs like quality of life. Following users feedback, it is desirable to better understand why and how mental workload is impacted by new technologies or features. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Lower Limb Amputation Above Knee (Injury)
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 21 Feb 2025to 31 Dec 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 18 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Population usually living or receiving care around investigation centers
Who may be able to join
- above-knee lower limb amputation
- using an above-knee prosthesis with prosthetic knee and foot
- eligible to use Synsys
- able to design therapeutic objectives for the GAS
- having a smartphone
Who cannot join
- protected person
- pregnant or breast-feeding lady
- knee-to-ground height lower than 43cm
- weighting more than 125kg
- using their prosthesis for less than 2 weeks
- not covered by health insurance
- aged less than 18 or more than 84 years old
- bilateral amputee or hip disarticulated
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
Multiple sites
Multiple Locations
Renaud Urbinelli, 0033658687286, rurbinelli@clin-experts.fr
About this study
Official title: Evaluation of Medical Benefit of a New Prosthetic Leg Designed to Decrease Mental Workload in People With Lower Limb Amputation
New generation of lower limb prosthesis provide improved functionalities. They are usually studied in the scope of biomechanics, sometimes PROMs like quality of life. Following users feedback, it is desirable to better understand why and how mental workload is impacted by new technologies or features. This clinical investigation will try to measure a difference between different prosthetic systems, in lab and in daily life.
Read the detailed description
Multicentric, national, observational, prospective study, using AB type SCED.
- Keywords
- microprocessor controlled, lower limb prosthesis, mental workload
- Medical subject headings
- Wounds and Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Goal Attainment Scale (GAS)
Scale from -3 to +2. The higher the better.
-3 being a deterioration, -2 being the baseline, 0 the objective, +2 the maximum
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (5)
L-test and Dual-task L-test
To assess locomotor capacity in divided attention on a short period
Measured: Initial visit, at 4 weeks, and at 8 weeks
Two-minute walk test (2MWT) and 2MWT in divided attention
to assess locomoto capacity and mental worload during a 2-minute exercise
Measured: Initial visit, at 4 weeks, and at 8 weeks
Activity Balance Confidence Scale (ABC-scale)
Patient reported balance confidence Scale from 0% (minimum) to 100% (maximum), the higher the better.
Measured: at 4 weeks, and at 8 weeks
Prosthesis Evaluation Questionnaire (PEQ-A)
Patient reported satisfaction Visual Analog Scale from 0% (minimum) to 100% (maximum) The higher the better
Measured: at 4 weeks, and at 8 weeks
Stumbles and falls
Self-reported number The lower the better
Measured: at 4 weeks, and at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start21 Feb 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb Amputation Above Knee (Injury)Studies 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Proteor Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laurine Calistri, MS, Study director, Proteor GroupIsabelle Loiret, DR, Principal investigator, UGECM Nord-Est, IRR, Centre Louis Pierquin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635655
- Sponsor's protocol ID
- 2023-A00581-44
- Acronym
- INCREMENT
- Status last verified
- Jul 2025
- First submitted
- 4 Oct 2024
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Medical Benefit of a New Prosthetic Leg Designed to Decrease Mental Workload in People With Lower Limb Amputation
- ClinicalTrials.gov ID
- NCT06635655
- Acronym / sponsor ID
- INCREMENT / 2023-A00581-44
- Keywords
- microprocessor controlled, lower limb prosthesis, mental workload
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Proteor GroupIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Oct 2024 (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.
New generation of lower limb prosthesis provide improved functionalities. They are usually studied in the scope of biomechanics, sometimes PROMs like quality of life. Following users feedback, it is desirable to better understand why and how mental workload is impacted by new technologies or features. This clinical investigation will try to measure a difference between different prosthetic systems, in lab and in daily life.
Detailed description
Multicentric, national, observational, prospective study, using AB type SCED.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population usually living or receiving care around investigation centers
Key inclusion criteria (5 listed)
- above-knee lower limb amputation
- using an above-knee prosthesis with prosthetic knee and foot
- eligible to use Synsys
- able to design therapeutic objectives for the GAS
- having a smartphone
Key exclusion criteria (8 listed)
- protected person
- pregnant or breast-feeding lady
- knee-to-ground height lower than 43cm
- weighting more than 125kg
- using their prosthesis for less than 2 weeks
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
Goal Attainment Scale (GAS)
Time frame: From enrollment to the end of treatment at 8 weeks
Scale from -3 to +2. The higher the better. -3 being a deterioration, -2 being the baseline, 0 the objective, +2 the maximum
5 secondary outcomes
L-test and Dual-task L-test
Time frame: Initial visit, at 4 weeks, and at 8 weeks
Two-minute walk test (2MWT) and 2MWT in divided attention
Time frame: Initial visit, at 4 weeks, and at 8 weeks
Activity Balance Confidence Scale (ABC-scale)
Time frame: at 4 weeks, and at 8 weeks
Prosthesis Evaluation Questionnaire (PEQ-A)
Time frame: at 4 weeks, and at 8 weeks
Stumbles and falls
Time frame: at 4 weeks, and at 8 weeks
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 9 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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.
Laurine Calistri, MS study director
Proteor Group
Isabelle Loiret, DR principal investigator
UGECM Nord-Est, IRR, Centre Louis Pierquin
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 Lower Limb Amputation Above Knee (Injury), run by Proteor Group 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 5 inclusion and 8 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 9 Jul 2025. 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 Renaud Urbinelli (0033658687286, rurbinelli@clin-experts.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Goal Attainment Scale (GAS) (time frame: From enrollment to the end of treatment at 8 weeks). 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 9 Jul 2025.