NCT05831696 Metabolic Cost of Walking With Passive vs. Powered Prosthetic Knees Among Persons With Limb Loss
| NCT ID | NCT05831696 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Loma Linda University |
| Condition | Transfemoral Amputation |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2023-02-27 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 12 participants in total. It began in 2023-02-27 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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)
Contact & Investigator
Michael Davidson, Ph.D.
PRINCIPAL INVESTIGATOR
Loma Linda University Health
Frequently Asked Questions
Who can join the NCT05831696 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Transfemoral Amputation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05831696 currently recruiting?
Yes, NCT05831696 is actively recruiting participants. Contact the research team at mdavidson@llu.edu for enrollment information.
Where is the NCT05831696 trial being conducted?
This trial is being conducted at Loma Linda, United States.
Who is sponsoring the NCT05831696 clinical trial?
NCT05831696 is sponsored by Loma Linda University. The principal investigator is Michael Davidson, Ph.D. at Loma Linda University Health. The trial plans to enroll 12 participants.