Overview
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.
Description
The Procedures include:
Initial Visit:
- Informed consent
- HIPAA authorization
- Determine/verify ambulation potential
- Take and record body measurements (height, weight, circumferences)
- Activities-Specific Balance Confidence (ABC) scale
- L.A.S.A.R. Posture alignment assessment with RxPx
Second Visit
- Fit with heartrate monitor and metabolic analyzer mask
- Treadmill Test (level-ground) with RxPx
- Rest
- Treadmill Test (incline) with RxPx
- Fit subject with PMPK
- L.A.S.A.R. Posture alignment assessment with PMPK
- Subject uses PMPK for one week as their primary prosthesis
Third Visit (1 week later)
- Fit with heartrate monitor and metabolic analyzer mask
- Treadmill Test (level-ground) with PMPK
- Rest
- Treadmill Test (incline) with PMPK
- Activities-Specific Balance Confidence (ABC) scale
- Return PMPK and refit of RxPx
- Verify alignment with L.A.S.A.R. Posture alignment
- Check that all fasteners are secure
Eligibility
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)