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.
Multicentric, national, observational, prospective study, using AB type SCED.
Study Type
OBSERVATIONAL
Enrollment
9
Multiple sites
Multiple Locations, France
RECRUITINGGoal 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 weeks
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 weeks
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 weeks
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 weeks
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 weeks
Stumbles and falls
Self-reported number The lower the better
Time frame: at 4 weeks, and at 8 weeks
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