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

NCT05831696 | Recruiting

• 1 other identifier: 5220320
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Transfemoral Amputation

Keywords

Power Knee; Amputation; Metabolic Costs; Heart Rate

Outcome Measures

Primary Outcomes (2)

• VO2 uptake - level ground

  VO2 uptake during ambulation on a treadmill - level ground

  Change between Baseline Visit (study enrollment) and Visit 2 (3 weeks post-study enrollment)

• VO2 uptake - incline

  VO2 uptake during ambulation on a treadmill - 5 degree incline

  Visit 2 (3 weeks post-study enrollment)

Secondary Outcomes (2)

• Balance confidence

  At Baseline Visit (study enrollment)

• Exertion

  Change between Visit 2 (3 weeks post-study enrollment) and Visit 3 (4 weeks post-study enrollment)

Study Arms (1)

Powered Microprocessor-controlled Knee (PMPK)

EXPERIMENTAL

the "Power Knee" is a commercially available PMPK.

Other: Powered Microprocessor-controlled Knee (PMPK)

Interventions

Powered Microprocessor-controlled Knee (PMPK) OTHER

A microprocessor-controlled Knee with standardized commercial prosthetic foot

Also known as: Power Knee

Powered Microprocessor-controlled Knee (PMPK)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and Females with unilateral knee disarticulation or transfemoral (KD/TF) amputation.
• a body mass greater than 49Kg and less than 117Kg
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Loma Linda University: lead
• Össur Iceland ehf: collaborator

Study Sites (1)

Loma Linda University

Loma Linda, California, 92354, United States

RECRUITING

Study Officials

• Michael Davidson, Ph.D.

  Loma Linda University Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Davidson, Ph.D.

CONTACT

9095586516; mdavidson@llu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be their own control

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: April 26, 2023
• Study Start: February 27, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

US (1)