NCT06017024
Completed
Not Applicable
Evaluation of a New Microprocessor-Controlled Prosthetic Knee : A Prospective, Multicentered, Randomized Cross-over Trial
Proteor Group5 sites in 1 country18 target enrollmentJune 7, 2023
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lower Limb Amputation Above Knee (Injury)
- Sponsor
- Proteor Group
- Enrollment
- 18
- Locations
- 5
- Primary Endpoint
- Personal goal achievement
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Personal goal achievement
Time Frame: test sessions 1 and 2 (20 minutes)
Patient-specific Functional Scale - PSFS - \[0-10\], the higher the better
Secondary Outcomes
- Functional walking test - fast walking speed(test sessions 1 and 2 (1 minute))
- Functional test - ability to walk downstairs(test sessions 1 and 2 (3 minutes))
- Questionnaire to assess satisfaction(test sessions 1 and 2 (5 minutes))
- Functional test - ability to walk downhill(test sessions 1 and 2 (3 minutes))
- Prosthesis Evaluation Questionnaire(test sessions 1 and 2 (29 minutes))
- Functional walking test - mobility capacity(test sessions 1 and 2 (8 minutes))
- Questionnaire to assess comfort in the socket(test sessions 1 and 2 (1 minute))
- Questionnaires to assess quality of life(test sessions 1 and 2 (5 minutes))
Study Sites (5)
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