TerminatedNot Applicable

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

Stopped: No more data collection needed under this protocol

United States6 participantsStarted 2024-12-02

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Sit to Stand Activity

Timeframe: after acclimatization at day 1 during the single study event

Stand to Sit Activity

Timeframe: after acclimatization at day 1 during the single study event

Level Ground Walking

Timeframe: after acclimatization at day 1 during the single study event

Trial details

NCT IDNCT06620861

SponsorÖssur Iceland ehf

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-06

Results submitted2025-10-23

View on ClinicalTrials.gov More Amputation trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.