New Microprocessor-Controlled Prosthetic Knee Evaluation

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of a New Microprocessor-Controlled Prosthetic Knee : A Prospective, Multicentered, Randomized Cross-over Trial

Conditions
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Lower Limb Amputation Above Knee (Injury)

Intervention / Treatment
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* Device: microprocessor-controlled knee (MPK) assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Current microprocessor-controlled knee (MPK) then New MPK<br>Start using current MPK for 4 weeks before fitting new MPK and use it for 4 weeks | Device: microprocessor-controlled knee (MPK) assessment<br>* The subject will wear the microprocessor-controlled knee prosthesis for 4 weeks, and then reply questionnaires and achieve functional tests<br>|
| Experimental: New MPK then Current MPK<br>Start using new MPK for 4 weeks before fitting back current MPK and use it for 4 weeks | Device: microprocessor-controlled knee (MPK) assessment<br>* The subject will wear the microprocessor-controlled knee prosthesis for 4 weeks, and then reply questionnaires and achieve functional tests<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Personal goal achievement | Patient-specific Functional Scale - PSFS - [0-10], the higher the better | test sessions 1 and 2 (20 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional walking test - mobility capacity | 6-minute walk test (6MWT) | test sessions 1 and 2 (8 minutes) | 
| Functional walking test - fast walking speed | 10-meter walk test (10mWT) | test sessions 1 and 2 (1 minute) | 
| Functional test - ability to walk downhill | Hill assessment index (HAI) [0-11], the higher the better | test sessions 1 and 2 (3 minutes) | 
| Functional test - ability to walk downstairs | Stairs assessment index (SAI) [0-13], the higher the better | test sessions 1 and 2 (3 minutes) | 
| Questionnaire to assess comfort in the socket | Socket comfort score (SCS) [0-10], the higher the better | test sessions 1 and 2 (1 minute) | 
| Questionnaire to assess satisfaction | Quebec User Evaluation of Satisfaction with assistive Technology (QUEST = ESAT in French); the higher the better | test sessions 1 and 2 (5 minutes) | 
| Questionnaires to assess quality of life | Short Form (36) health survey (SF-36); the higher the better | test sessions 1 and 2 (5 minutes) | 
| Prosthesis Evaluation Questionnaire | PEQ, 8 sub-scales [0-100], the higher the better | test sessions 1 and 2 (29 minutes) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Micro-processor controlled knee, Lower Limb prosthesis, Patient-specific Functional Scale