NCT05831696 · Loma Linda University
Metabolic Cost of Walking With Passive vs. Powered Prosthetic Knees Among Persons With Limb Loss
What this study is about
The purpose of this industry-initiated research study is to test that a powered microprocessor controlled knee improves metabolic function during walking in level and sloped conditions as compared to the subject's physician prescribed prosthesis.
View original scientific description
The purpose of this industry-initiated research study is to test that a powered microprocessor controlled knee improves metabolic function during walking in level and sloped conditions as compared to the subject's physician prescribed prosthesis.
Interventions
OTHER
Powered Microprocessor-controlled Knee (PMPK)
A microprocessor-controlled Knee with standardized commercial prosthetic foot
Primary outcome measures
VO2 uptake - level ground
Time frame: Change between Baseline Visit (study enrollment) and Visit 2 (3 weeks post-study enrollment)
VO2 uptake during ambulation on a treadmill - level ground
VO2 uptake - incline
Time frame: Visit 2 (3 weeks post-study enrollment)
VO2 uptake during ambulation on a treadmill - 5 degree incline
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Males and Females with unilateral knee disarticulation or transfemoral (KD/TF) amputation.
- a body mass greater than 49Kg and less than 117Kg
- 18-75 years of age
- Have an ambulation potential of K3 or K4
- Use a prosthesis daily for walking or sports activities
- No less than six months of experience with a prosthesis
- No socket issues or changes in the last six weeks
- No residual limb pain affecting functional ability.
Exclusion criteria
- Cannot walk at different speeds (MCFL K0-K2)
- Limb-loss below the knee or through the hip
- More than one amputation.
- Uses an assistive device for walking
- Uncontrolled edema in leg compartments
- Compromised skin of the residual limb or contralateral foot
- Are 180 days or less post-amputation
- Pregnant (self-reported)
Where
- Loma Linda, California
Collaborators
Össur Iceland ehf
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 4, 2026 · Source of record for eligibility and locations