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.
The Procedures include: 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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
12
A microprocessor-controlled Knee with standardized commercial prosthetic foot
Loma Linda University
Loma Linda, California, United States
RECRUITINGVO2 uptake - level ground
VO2 uptake during ambulation on a treadmill - level ground
Time frame: Change between Baseline Visit (study enrollment) and Visit 2 (3 weeks post-study enrollment)
VO2 uptake - incline
VO2 uptake during ambulation on a treadmill - 5 degree incline
Time frame: Visit 2 (3 weeks post-study enrollment)
Balance confidence
Activities based balance confidence survey (0-100%) higher score means more balance confidence
Time frame: At Baseline Visit (study enrollment)
Exertion
Borg Exertion Scale (0-10) with 10 being maximum exertion
Time frame: Change between Visit 2 (3 weeks post-study enrollment) and Visit 3 (4 weeks post-study enrollment)
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