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

July 8, 2025 updated by: Proteor Group

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Estimated)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Population usually living or receiving care around investigation centers

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From enrollment to the end of treatment at 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
L-test and Dual-task L-test
Time Frame: Initial visit, at 4 weeks, and at 8 weeks
To assess locomotor capacity in divided attention on a short period
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
to assess locomoto capacity and mental worload during a 2-minute exercise
Initial visit, at 4 weeks, and at 8 weeks
Activity Balance Confidence Scale (ABC-scale)
Time Frame: at 4 weeks, and at 8 weeks
Patient reported balance confidence Scale from 0% (minimum) to 100% (maximum), the higher the better.
at 4 weeks, and at 8 weeks
Prosthesis Evaluation Questionnaire (PEQ-A)
Time Frame: at 4 weeks, and at 8 weeks
Patient reported satisfaction Visual Analog Scale from 0% (minimum) to 100% (maximum) The higher the better
at 4 weeks, and at 8 weeks
Stumbles and falls
Time Frame: at 4 weeks, and at 8 weeks
Self-reported number The lower the better
at 4 weeks, and at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Proteor Group

Investigators

  • Study Director: Laurine Calistri, MS, Proteor Group
  • Principal Investigator: Isabelle Loiret, DR, UGECM Nord-Est, IRR, Centre Louis Pierquin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

October 4, 2024

First Submitted That Met QC Criteria

October 8, 2024

First Posted (Actual)

October 10, 2024

Study Record Updates

Last Update Posted (Actual)

July 9, 2025

Last Update Submitted That Met QC Criteria

July 8, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2023-A00581-44

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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