Assessment of the Prosthetic System Impact on Mental Workload in Above-knee Lower Limb Amputees.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Lower Limb Amputation Above Knee (Injury). Basic parameters: 18 years — 84 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Medical Benefit of a New Prosthetic Leg Designed to Decrease Mental Workload in People With Lower Limb Amputation
Overview
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.
Primary outcome measures
- Goal Attainment Scale (GAS) [Time frame: From enrollment to the end of treatment at 8 weeks]
Secondary outcome measures (5)
- L-test and Dual-task L-test [Time frame: 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]
- Activity Balance Confidence Scale (ABC-scale) [Time frame: at 4 weeks, and at 8 weeks]
- Prosthesis Evaluation Questionnaire (PEQ-A) [Time frame: at 4 weeks, and at 8 weeks]
- Stumbles and falls [Time frame: at 4 weeks, and at 8 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-crossover
Study locations
France · 1 center
- Multiple sites — Multiple Locations
Identifiers
NCT: NCT06635655 · 2023-A00581-44