New Microprocessor-Controlled Prosthetic Knee Evaluation

Last updated: December 11, 2024
Sponsor: Proteor Group
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

microprocessor-controlled knee (MPK) assessment

Clinical Study ID

NCT06017024
2022-A01266-37
  • Ages 18-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 18
Treatment Group(s): 1
Primary Treatment: microprocessor-controlled knee (MPK) assessment
Phase:
Study Start date:
June 07, 2023
Estimated Completion Date:
December 11, 2024

Connect with a study center

  • Hôpital Léon Bérard

    Hyères,
    France

    Site Not Available

  • Clinique du Dr Ster

    Lamalou-les-Bains,
    France

    Site Not Available

  • UGECAM Nord-Est IRR

    Nancy,
    France

    Site Not Available

  • Centre Mutualiste de Kerpape

    Ploemeur,
    France

    Site Not Available

  • UGECAM La Tourmaline

    Saint-Herblain,
    France

    Site Not Available

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