Lower Limb Amputation Above Knee (Injury)
Conditions
Keywords
Micro-processor controlled knee, Lower Limb prosthesis, Patient-specific Functional Scale
Brief summary
The target of this clinical investigation is to compare the achievement of personal functional goals using a new MPK and current MPK. Subjects will also run functional tests and questionnaires to compare performances and feedback with each prosthetic knee.
Interventions
DEVICEmicroprocessor-controlled knee (MPK) assessment
The subject will wear the microprocessor-controlled knee prosthesis for 4 weeks, and then reply questionnaires and achieve functional tests
Sponsors
Proteor Group
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Able to understand and give informed consent * Man or woman, more than 18 y.o * Lower limb amputee KD or AKA, unilateral or bilateral * K3/K4 activity level * Already fitted with FR-reimbursed MPK * Being comfortable in their socket (SCS\>=5)
Exclusion criteria
* Protected person * Pregnant or breast feeding lady * Person having pathologies affecting their sensitivity * Using walking aids * Weighting more than 136kg * Insufficient hip joint or pelvic voluntary muscle control * Insufficient cognitive ability to charge the knee and care for the device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Personal goal achievement | test sessions 1 and 2 (20 minutes) | Patient-specific Functional Scale - PSFS - \[0-10\], the higher the better |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional walking test - fast walking speed | test sessions 1 and 2 (1 minute) | 10-meter walk test (10mWT) |
| Functional test - ability to walk downhill | test sessions 1 and 2 (3 minutes) | Hill assessment index (HAI) \[0-11\], the higher the better |
| Functional test - ability to walk downstairs | test sessions 1 and 2 (3 minutes) | Stairs assessment index (SAI) \[0-13\], the higher the better |
| Functional walking test - mobility capacity | test sessions 1 and 2 (8 minutes) | 6-minute walk test (6MWT) |
| Questionnaire to assess satisfaction | test sessions 1 and 2 (5 minutes) | Quebec User Evaluation of Satisfaction with assistive Technology (QUEST = ESAT in French); the higher the better |
| Questionnaires to assess quality of life | test sessions 1 and 2 (5 minutes) | Short Form (36) health survey (SF-36); the higher the better |
| Prosthesis Evaluation Questionnaire | test sessions 1 and 2 (29 minutes) | PEQ, 8 sub-scales \[0-100\], the higher the better |
| Questionnaire to assess comfort in the socket | test sessions 1 and 2 (1 minute) | Socket comfort score (SCS) \[0-10\], the higher the better |
Countries
France
Outcome results
None listed