Clinical trial NCT05831696: Metabolic Cost of Walking With Passive vs. Powered Prosthetic Knees Among Persons With Limb Loss
Official title: Metabolic Cost of Walking With Passive vs. Powered Prosthetic Knees Among Persons With Limb Loss
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Transfemoral Amputation
Keywords: Power Knee
Amputation
Metabolic Costs
Heart Rate
Lead sponsor: Loma Linda University
Sponsor class: OTHER
Collaborators: name: Össur Iceland ehf
First posted: 2023-04-26
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants will be their own control
Primary purpose: OTHER

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

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)

Primary outcomes:
measure: VO2 uptake - level ground
timeFrame: Change between Baseline Visit (study enrollment) and Visit 2 (3 weeks post-study enrollment)
measure: VO2 uptake - incline
timeFrame: Visit 2 (3 weeks post-study enrollment)
Secondary outcomes:
measure: Balance confidence
timeFrame: At Baseline Visit (study enrollment)
measure: Exertion
timeFrame: Change between Visit 2 (3 weeks post-study enrollment) and Visit 3 (4 weeks post-study enrollment)
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
Study officials:
affiliation: Loma Linda University Health
name: Michael Davidson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: