Assessment of the Prosthetic System Impact on Mental Work... | NCT06635655

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

NCT06635655

Sponsor

Proteor Group

Status

Recruiting

Last Update Posted

Jul 9, 2025Actual

Enrollment

9Estimated

Phase

Not provided

Conditions

Lower Limb Amputation Above Knee (Injury)

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 21, 2025Actual

Primary Completion Date

Sep 30, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Oct 4, 2024

First Submission Date that Met QC Criteria

Oct 8, 2024

First Posted Date

Oct 10, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 8, 2025

Last Update Posted Date

Jul 9, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

9Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
L-test and Dual-task L-test	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

84 Years

Standard Ages

AdultOlder Adult

Study Population

Population usually living or receiving care around investigation centers

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Renaud Urbinelli	Contact	0033658687286		rurbinelli@clin-experts.fr

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Multiple sites	Recruiting	Multiple Locations			France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014947	Wounds and Injuries

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided