Metabolic Cost of Walking With Passive vs. Powered Prosthetic Knees Among Persons With Limb Loss
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Powered Microprocessor-controlled Knee (PMPK).
- Who it may be relevant to
- Registry conditions: Transfemoral Amputation. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
Detailed description
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
Interventions
- Other Powered Microprocessor-controlled Knee (PMPK)
A microprocessor-controlled Knee with standardized commercial prosthetic foot
Primary outcome measures
- VO2 uptake - level ground [Time frame: Change between Baseline Visit (study enrollment) and Visit 2 (3 weeks post-study enrollment)]
- VO2 uptake - incline [Time frame: Visit 2 (3 weeks post-study enrollment)]
Secondary outcome measures (2)
- Balance confidence [Time frame: At Baseline Visit (study enrollment)]
- Exertion [Time frame: Change between Visit 2 (3 weeks post-study enrollment) and Visit 3 (4 weeks post-study enrollment)]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Loma Linda University — Loma Linda
Identifiers
NCT: NCT05831696 · 5220320