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Prosthetic Device

Power Knee for Above Knee Amputation

N/A
Recruiting
Led By Jennifer Johansson, MS
Research Sponsored by Liberating Technologies, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Unilateral transfemoral prosthesis user (limb absence between the knee and hip)
Subjects in this study will not be discriminated by sex/gender or race/ethnicity.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up monitored over entire study (6 months)
Awards & highlights

Study Summary

This trial is testing different types of powered prosthetic knees to see which one works best for each type of patient. The larger follow-on trial will explore different types of powered prosthetic knees with the goal of helping to design future devices.

Who is the study for?
This trial is for adults over 18 with above-knee amputations who have been using a microprocessor-controlled prosthetic knee. They should be very active (K-Level: 4), weigh between 110-256 lbs, and have a well-fitting prosthesis socket. Pregnant women or those at risk of falling due to unfamiliarity with the device are excluded.Check my eligibility
What is being tested?
The study compares powered prosthetic knees (Power Knee) with passive ones in highly active individuals who've lost a leg above the knee. It aims to determine which device offers more benefits in daily life, guiding future prescriptions and design improvements.See study design
What are the potential side effects?
While specific side effects aren't listed, there's an increased risk of falls when adjusting to new prosthetics, especially for those not used to the Power Knee being tested.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I use a prosthesis for one leg, between my knee and hip.
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My participation is not limited by my sex/gender or race/ethnicity.
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My weight is between 110lbs and 256lbs.
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I have used a prosthesis for at least 6 months.
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I am 18 years old or older.
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I have enough space below my knee for needed prosthetic parts.
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I am very active and can handle most types of physical activity.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~monitored over entire study (6 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and monitored over entire study (6 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Activities-Specific Balance Confidence scale (ABC) - Measuring change from baseline
PEQ-Well Being (PEQ-WB) - Measuring change from baseline
Step count
Secondary outcome measures
Borg Rating of Perceived Exertion (RPE)
Hill Assessment Index (HAI)
Oswestry Disability Index (ODI)
+10 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Power KneeExperimental Treatment1 Intervention
The subject will wear the Ossur PK in place of their usual MPK for 3 months, as well as in the lab to complete outcome measures.
Group II: Comparator BaselineActive Control1 Intervention
The subject will wear their usual Microprocessor Knee (MPK) for 3 months, as well as in the lab to complete outcome measures.

Find a Location

Who is running the clinical trial?

Liberating Technologies, Inc.Lead Sponsor
11 Previous Clinical Trials
85 Total Patients Enrolled
Hanger Clinic: Prosthetics & OrthoticsOTHER
9 Previous Clinical Trials
383 Total Patients Enrolled
Jennifer Johansson, MSPrincipal InvestigatorLiberating Technologies, Inc.
1 Previous Clinical Trials
26 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What aims is this clinical trial hoping to accomplish?

"The main objective of this six-month study is to assess the PEQ-Well Being (PEQ-WB) metric from baseline. Secondary outcomes include Six Minute Walk Test (6MWT), Stair Assessment Index (SAI), and Physiological Cost Index (PCI). The 6MWT measures walking endurance and aerobic capacity over a set circuit for a total of six minutes, SAI evaluates an individual's ability to ascend and descend stairs on an ordinal scale, while PCI uses heart rate data with respect to resting HR, working HR, and walking speed in order to calculate energy expenditure during motion."

Answered by AI

How many volunteers are involved in this experiment?

"Affirmative. The clinical trial's online listing on clinicaltrials.gov states that recruitment is currently in progress - the study was initially announced May 1st 2022 and last updated May 19th 2022, with 12 participants needed from two sites."

Answered by AI

Is there currently intake for this research project?

"Affirmative. According to records on clinicaltrials.gov, this experiment is actively inviting participants in as of now--the trial was initially posted on May 1st 2022 and updated most recently on the 19th of May 2022. The study requires 12 people over 2 centres."

Answered by AI
~1 spots leftby Apr 2024