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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06017024
Other study ID # 2022-A01266-37
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 7, 2023
Est. completion date August 31, 2025

Study information

Verified date August 2023
Source Proteor Group
Contact Laurine Calistri, MS
Phone +33779825147
Email laurine.calistri@proteor.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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Study Design


Related Conditions & MeSH terms

  • Lower Limb Amputation Above Knee (Injury)

Intervention

Device:
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

Locations

Country Name City State
France 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

Sponsors (1)

Lead Sponsor Collaborator
Proteor Group

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Personal goal achievement Patient-specific Functional Scale - PSFS - [0-10], the higher the better test sessions 1 and 2 (20 minutes)
Secondary Functional walking test - mobility capacity 6-minute walk test (6MWT) test sessions 1 and 2 (8 minutes)
Secondary Functional walking test - fast walking speed 10-meter walk test (10mWT) test sessions 1 and 2 (1 minute)
Secondary Functional test - ability to walk downhill Hill assessment index (HAI) [0-11], the higher the better test sessions 1 and 2 (3 minutes)
Secondary Functional test - ability to walk downstairs Stairs assessment index (SAI) [0-13], the higher the better test sessions 1 and 2 (3 minutes)
Secondary Questionnaire to assess comfort in the socket Socket comfort score (SCS) [0-10], the higher the better test sessions 1 and 2 (1 minute)
Secondary 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)
Secondary Questionnaires to assess quality of life Short Form (36) health survey (SF-36); the higher the better test sessions 1 and 2 (5 minutes)
Secondary Prosthesis Evaluation Questionnaire PEQ, 8 sub-scales [0-100], the higher the better test sessions 1 and 2 (29 minutes)
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