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NCT Number: NCT06017024

New Microprocessor-Controlled Prosthetic Knee Evaluation

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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Key information

Conditions

Lower Limb Amputation Above Knee (Injury) Wounds and Injuries

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Léon Bérard, Hyères, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Personal goal achievement

    Time frame: test sessions 1 and 2 (20 minutes)

    Patient-specific Functional Scale - PSFS - [0-10], the higher the better

Secondary outcomes

  1. Functional walking test - mobility capacity

    Time frame: test sessions 1 and 2 (8 minutes)

    6-minute walk test (6MWT)

  2. Functional walking test - fast walking speed

    Time frame: test sessions 1 and 2 (1 minute)

    10-meter walk test (10mWT)

  3. Functional test - ability to walk downhill

    Time frame: test sessions 1 and 2 (3 minutes)

    Hill assessment index (HAI) [0-11], the higher the better

  4. Functional test - ability to walk downstairs

    Time frame: test sessions 1 and 2 (3 minutes)

    Stairs assessment index (SAI) [0-13], the higher the better

  5. Questionnaire to assess comfort in the socket

    Time frame: test sessions 1 and 2 (1 minute)

    Socket comfort score (SCS) [0-10], the higher the better

  6. Questionnaire to assess satisfaction

    Time frame: test sessions 1 and 2 (5 minutes)

    Quebec User Evaluation of Satisfaction with assistive Technology (QUEST = ESAT in French); the higher the better

  7. Questionnaires to assess quality of life

    Time frame: test sessions 1 and 2 (5 minutes)

    Short Form (36) health survey (SF-36); the higher the better

  8. Prosthesis Evaluation Questionnaire

    Time frame: test sessions 1 and 2 (29 minutes)

    PEQ, 8 sub-scales [0-100], the higher the better

Sponsors and collaborators

Lead sponsor

Proteor Group

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 30, 2023
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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