CompletedNot Applicable

New Microprocessor-Controlled Prosthetic Knee Evaluation

France18 participantsStarted 2023-06-07

Plain-language 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.

Who can participate

Age range18 Years – 85 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Personal goal achievement

Timeframe: test sessions 1 and 2 (20 minutes)

Trial details

NCT IDNCT06017024

SponsorProteor Group

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-11

View on ClinicalTrials.gov More Lower Limb Amputation Above Knee (Injury) trials