RecruitingNot ApplicableNCT05831696
Metabolic Cost of Walking With Passive vs. Powered Prosthetic Knees Among Persons With Limb Loss
Sponsor
Loma Linda University
Enrollment
12 participants
Start Date
Feb 27, 2023
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria8
- Males and Females with unilateral knee disarticulation or transfemoral (KD/TF) amputation.
- a body mass greater than 49Kg and less than 117Kg
- -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 Criteria8
- 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)
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Interventions
OTHERPowered Microprocessor-controlled Knee (PMPK)
A microprocessor-controlled Knee with standardized commercial prosthetic foot
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05831696
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