Transfemoral Amputation
Conditions
Keywords
Power Knee, Amputation, Metabolic Costs, Heart Rate
Brief 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.
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
OTHERPowered Microprocessor-controlled Knee (PMPK)
A microprocessor-controlled Knee with standardized commercial prosthetic foot
Sponsors
Loma Linda University
Össur Iceland ehf
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Participants will be their own control
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VO2 uptake - level ground | Change between Baseline Visit (study enrollment) and Visit 2 (3 weeks post-study enrollment) | VO2 uptake during ambulation on a treadmill - level ground |
| VO2 uptake - incline | Visit 2 (3 weeks post-study enrollment) | VO2 uptake during ambulation on a treadmill - 5 degree incline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Balance confidence | At Baseline Visit (study enrollment) | Activities based balance confidence survey (0-100%) higher score means more balance confidence |
| Exertion | Change between Visit 2 (3 weeks post-study enrollment) and Visit 3 (4 weeks post-study enrollment) | Borg Exertion Scale (0-10) with 10 being maximum exertion |
Countries
United States
Contacts
CONTACTMichael Davidson, Ph.D.
PRINCIPAL_INVESTIGATORMichael Davidson, Ph.D.
Loma Linda University Health
Outcome results
None listed