New Microprocessor-Controlled Prosthetic Knee Evaluation

Proteor Group18 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Lower Limb Amputation Above Knee (Injury)

Interventions

microprocessor-controlled knee (MPK) assessmentDEVICE

The subject will wear the microprocessor-controlled knee prosthesis for 4 weeks, and then reply questionnaires and achieve functional tests

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (5)

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

Outcomes

Primary Outcomes

Personal goal achievement

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

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

Secondary Outcomes

Functional walking test - mobility capacity

6-minute walk test (6MWT)

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

Functional walking test - fast walking speed

10-meter walk test (10mWT)

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

Functional test - ability to walk downhill

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

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

Functional test - ability to walk downstairs

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

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

Questionnaire to assess comfort in the socket

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

Time frame: 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

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

Questionnaires to assess quality of life

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

Data from ClinicalTrials.gov

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