New Microprocessor-Controlled Prosthetic Knee Evaluation
NCT ID: NCT06017024
Last Updated: 2024-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
18 participants
INTERVENTIONAL
2023-06-07
2024-12-11
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Current microprocessor-controlled knee (MPK) then New MPK
Start using current MPK for 4 weeks before fitting new MPK and use it for 4 weeks
microprocessor-controlled knee (MPK) assessment
The subject will wear the microprocessor-controlled knee prosthesis for 4 weeks, and then reply questionnaires and achieve functional tests
New MPK then Current MPK
Start using new MPK for 4 weeks before fitting back current MPK and use it for 4 weeks
microprocessor-controlled knee (MPK) assessment
The subject will wear the microprocessor-controlled knee prosthesis for 4 weeks, and then reply questionnaires and achieve functional tests
Interventions
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microprocessor-controlled knee (MPK) assessment
The subject will wear the microprocessor-controlled knee prosthesis for 4 weeks, and then reply questionnaires and achieve functional tests
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
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Proteor Group
INDUSTRY
Responsible Party
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Locations
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Hôpital Léon Bérard
Hyères, , France
Clinique du Dr Ster
Lamalou-les-Bains, , France
UGECAM Nord-Est IRR
Nancy, , France
Centre Mutualiste de Kerpape
Ploemeur, , France
UGECAM La Tourmaline
Saint-Herblain, , France
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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2022-A01266-37
Identifier Type: -
Identifier Source: org_study_id