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

Stopped early · Not applicable

Conditions studied: Amputation, Transfemoral Amputation

In brief

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.

Key facts

Study ID: NCT06620861
Run by: Össur Iceland ehf
People needed: 6
Starts: 2024-12-02
Expected to finish: 2024-12-06
Last updated by the study team: 2026-01-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Oakland Orthopedic Appliances Inc — Bay City, Michigan, United States

Full record on ClinicalTrials.gov

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