Assessment of the Prosthetic System Impact on Mental Workload in Above-knee Lower Limb Amputees.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-84
SponsorProteor Group
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
protected person
pregnant or breast-feeding lady
knee-to-ground height lower than 43cm
weighting more than 125kg
Trial population
Population usually living or receiving care around investigation centers
Trial design
Design model
Case-crossover
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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
Time frame
From enrollment to the end of treatment at 8 weeksSecondary outcomes
1
L-test and Dual-task L-test
To assess locomotor capacity in divided attention on a short period
Time frame
Initial visit, at 4 weeks, and at 8 weeks2
Two-minute walk test (2MWT) and 2MWT in divided attention
to assess locomoto capacity and mental worload during a 2-minute exercise
Time frame
Initial visit, at 4 weeks, and at 8 weeks3
Activity Balance Confidence Scale (ABC-scale)
Patient reported balance confidence Scale from 0% (minimum) to 100% (maximum), the higher the better.
Time frame
at 4 weeks, and at 8 weeks4
Prosthesis Evaluation Questionnaire (PEQ-A)
Patient reported satisfaction Visual Analog Scale from 0% (minimum) to 100% (maximum) The higher the better
Time frame
at 4 weeks, and at 8 weeksLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Multiple sitesRecruiting Multiple Locations
France
FranceSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov