New Microprocessor-Controlled Prosthetic Knee Evaluation

Proteor Group

Status: Completed

Conditions: Lower Limb Amputation Above Knee (Injury)

Treatments: Device: microprocessor-controlled knee (MPK) assessment

Study type: Interventional

Funder types: Industry

Identifiers

NCT06017024

2022-A01266-37

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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18 participants in 2 patient groups

Current microprocessor-controlled knee (MPK) then New MPK

Experimental group

Description:

Start using current MPK for 4 weeks before fitting new MPK and use it for 4 weeks

Treatment:

Device: microprocessor-controlled knee (MPK) assessment

New MPK then Current MPK

Experimental group

Description:

Start using new MPK for 4 weeks before fitting back current MPK and use it for 4 weeks

Treatment:

Device: microprocessor-controlled knee (MPK) assessment