Metabolic Cost of Walking With Passive vs. Powered Prosthetic Knees Among Persons With Limb Loss
NCT ID: NCT05831696
Last Updated: 2025-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
12 participants
INTERVENTIONAL
2023-02-27
2025-12-31
Brief Summary
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Detailed Description
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Initial Visit:
1. Informed consent
2. HIPAA authorization
3. Determine/verify ambulation potential
4. Take and record body measurements (height, weight, circumferences)
5. Activities-Specific Balance Confidence (ABC) scale
6. L.A.S.A.R. Posture alignment assessment with RxPx
Second Visit
1. Fit with heartrate monitor and metabolic analyzer mask
2. Treadmill Test (level-ground) with RxPx
3. Rest
4. Treadmill Test (incline) with RxPx
5. Fit subject with PMPK
6. L.A.S.A.R. Posture alignment assessment with PMPK
7. Subject uses PMPK for one week as their primary prosthesis
Third Visit (1 week later)
1. Fit with heartrate monitor and metabolic analyzer mask
2. Treadmill Test (level-ground) with PMPK
3. Rest
4. Treadmill Test (incline) with PMPK
5. Activities-Specific Balance Confidence (ABC) scale
6. Return PMPK and refit of RxPx
7. Verify alignment with L.A.S.A.R. Posture alignment
8. Check that all fasteners are secure
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Powered Microprocessor-controlled Knee (PMPK)
the "Power Knee" is a commercially available PMPK.
Powered Microprocessor-controlled Knee (PMPK)
A microprocessor-controlled Knee with standardized commercial prosthetic foot
Interventions
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Powered Microprocessor-controlled Knee (PMPK)
A microprocessor-controlled Knee with standardized commercial prosthetic foot
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
75 Years
ALL
No
Sponsors
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Össur Iceland ehf
INDUSTRY
Loma Linda University
OTHER
Responsible Party
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Principal Investigators
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Michael Davidson, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Loma Linda University Health
Locations
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Loma Linda University
Loma Linda, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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5220320
Identifier Type: -
Identifier Source: org_study_id
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