Lower Limb Amputation Above Knee (Injury)
Conditions
Keywords
microprocessor controlled, lower limb prosthesis, mental workload
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.
Interventions
None listed
Sponsors
Proteor Group
Study design
Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 84 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Goal Attainment Scale (GAS) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| L-test and Dual-task L-test | Initial visit, at 4 weeks, and at 8 weeks | To assess locomotor capacity in divided attention on a short period |
| Two-minute walk test (2MWT) and 2MWT in divided attention | Initial visit, at 4 weeks, and at 8 weeks | to assess locomoto capacity and mental worload during a 2-minute exercise |
| Activity Balance Confidence Scale (ABC-scale) | at 4 weeks, and at 8 weeks | Patient reported balance confidence Scale from 0% (minimum) to 100% (maximum), the higher the better. |
| Prosthesis Evaluation Questionnaire (PEQ-A) | at 4 weeks, and at 8 weeks | Patient reported satisfaction Visual Analog Scale from 0% (minimum) to 100% (maximum) The higher the better |
| Stumbles and falls | at 4 weeks, and at 8 weeks | Self-reported number The lower the better |
Countries
France
Contacts
Primary ContactRenaud Urbinelli
Outcome results
None listed