Investigation on a New Power Knee Firmware Update on Gait and Daily Life Activities for Transfemoral Amputees

Össur Iceland ehf

Status

Terminated

Conditions

Transfemoral Amputation

Amputation

Treatments

Device: Power Knee Current Marketed Firmware

Device: Power Knee Firmware Update

Study type

Interventional

Funder types

Industry

Identifiers

NCT06620861

CIP2024070123

Details and patient eligibility

About

The goal of this interventional study is to investigate a new firmware in development for Power Knee on gait and daily life activities in unilateral transfemoral amputees. The main question it aims to answer is:

What are the effects of a new firmware on sit-to-stand, level walking and stair ascent ?

Researchers will compare both a new and the current marketed firmware to see if there is any changes in performance.

Participants will be asked to perform some activities of daily living and some functional tests.

Enrollment

6 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

50 kg < body weight < 116 kg
lower limb loss, amputation or deficiency
cognitive ability to understand all instructions and questionnaires in the study
Unilateral transfemoral amputees that are regular Power Knee users for at least 4 weeks
age ≥ 18 years
Moderate to high active subjects
Willing and able to participate in the study and follow the protocol
Comfortable and stable socket fit
No socket issues/changes in the last 6 weeks

Exclusion criteria

Users with pain
Bilateral amputees
Users using passive microprocessor controlled knees
Users with cognitive impairment
Users with co-morbidities in the contra lateral limb, which affect their functional mobility
Hip disarticulation amputees
Users with osseointegrated prosthesis
Pregnant users