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Metabolic Cost of Walking With Passive vs. Powered Prosthetic Knees Among Persons With Limb Loss

Sponsor
Loma Linda University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05831696
Collaborator
Össur Ehf (Industry)
12
Enrollment
1
Location
1
Arm
10.1
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Powered Microprocessor-controlled Knee (PMPK)
 N/A

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Participants will be their own controlParticipants will be their own control
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Metabolic Cost of Walking With Passive vs. Powered Prosthetic Knees Among Persons With Limb Loss
Actual Study Start Date :
Feb 27, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Powered Microprocessor-controlled Knee (PMPK)

the "Power Knee" is a commercially available PMPK.

Other: Powered Microprocessor-controlled Knee (PMPK)
A microprocessor-controlled Knee with standardized commercial prosthetic foot
Other Names:
  • Power Knee

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. VO2 uptake - incline [Visit 2 (3 weeks post-study enrollment)]

      VO2 uptake during ambulation on a treadmill - 5 degree incline

    Secondary Outcome Measures

    1. Balance confidence [At Baseline Visit (study enrollment)]

      Activities based balance confidence survey (0-100%) higher score means more balance confidence

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Loma Linda University Loma Linda California United States 92354

    Sponsors and Collaborators

    • Loma Linda University
    • Össur Ehf

    Investigators

    • Principal Investigator: Michael Davidson, Ph.D., Loma Linda University Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Michael Davidson, Assistant Professor, Loma Linda University
    ClinicalTrials.gov Identifier:
    NCT05831696
    Other Study ID Numbers:
    • 5220320
    First Posted:
    Apr 26, 2023
    Last Update Posted:
    Apr 26, 2023
    Last Verified:
    Apr 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Michael Davidson, Assistant Professor, Loma Linda University
    Power Knee
    Amputation
    Metabolic Costs
    Heart Rate

    Study Results

    No Results Posted as of Apr 26, 2023