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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Current microprocessor-controlled knee (MPK) then New MPK | Experimental | Start using current MPK for 4 weeks before fitting new MPK and use it for 4 weeks |
|
| New MPK then Current MPK | Experimental | Start using new MPK for 4 weeks before fitting back current MPK and use it for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| microprocessor-controlled knee (MPK) assessment | Device | The subject will wear the microprocessor-controlled knee prosthesis for 4 weeks, and then reply questionnaires and achieve functional tests |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Léon Bérard | Hyères | France | ||||
| Clinique du Dr Ster |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 16, 2023 | Aug 16, 2023 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D010808 | Physical Examination |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| 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) |
| Lamalou-les-Bains |
| France |
| UGECAM Nord-Est IRR | Nancy | France |
| Centre Mutualiste de Kerpape | Ploemeur | France |
| UGECAM La Tourmaline | Saint-Herblain | France |