Assessment of the Prosthetic System Impact on Mental Workload in Above-knee Lower Limb Amputees.

NCT ID: NCT06635655

Last Updated: 2025-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-21

Study Completion Date

2026-12-31

Brief Summary

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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

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Multicentric, national, observational, prospective study, using AB type SCED.

Conditions

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Lower Limb Amputation Above Knee (Injury)

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Proteor Group

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laurine Calistri, MS

Role: STUDY_DIRECTOR

Proteor Group

Isabelle Loiret, DR

Role: PRINCIPAL_INVESTIGATOR

UGECM Nord-Est, IRR, Centre Louis Pierquin

Locations

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Multiple sites

Multiple Locations, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Renaud Urbinelli

Role: CONTACT

0033658687286

Facility Contacts

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Renaud Urbinelli

Role: primary

0033658687286

Other Identifiers

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2023-A00581-44

Identifier Type: -

Identifier Source: org_study_id

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