Comparing walking with powered and passive prosthetic knees for amputees
Metabolic Cost of Walking With Passive vs. Powered Prosthetic Knees Among Persons With Limb Loss
This study tests whether walking with a powered prosthetic knee is easier and more efficient for people with leg amputations compared to using a standard knee.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Loma Linda University Academic / other |
| Locations | 1 site (Loma Linda, California) |
| Trial ID | NCT05831696 on ClinicalTrials.gov |
What this trial studies
This research evaluates the metabolic costs associated with walking using a powered microprocessor-controlled knee compared to a standard prosthesis among individuals with transfemoral amputation. Participants will undergo a series of treadmill tests to measure heart rate and metabolic function while using both types of prosthetic knees. The study aims to determine if the powered knee improves walking efficiency in various conditions, including level ground and inclines. Participants will be fitted with a metabolic analyzer and heart rate monitor to collect data during the tests.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18-75 with unilateral transfemoral amputation who have experience using a prosthesis and demonstrate a high level of ambulation potential.
Not a fit: Patients who have multiple amputations, those who cannot walk at different speeds, or who are less than 180 days post-amputation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved walking efficiency and quality of life for amputees using powered prosthetic knees.
How similar studies have performed: Previous studies have shown promising results with powered prosthetic devices, indicating potential benefits in mobility and metabolic efficiency.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Loma Linda, California
- Loma Linda University — Loma Linda, California, United States (Recruiting)
Study contacts
- Principal investigator: Michael Davidson, Ph.D. — Loma Linda University Health
- Study coordinator: Michael Davidson, Ph.D.
- Email: mdavidson@llu.edu
- Phone: 9095586516
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.