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

ConditionTransfemoral Amputation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorLoma Linda University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Powered Microprocessor-controlled Knee (PMPK)

    Other intervention

    A microprocessor-controlled Knee with standardized commercial prosthetic foot

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: Powered Microprocessor-controlled Knee (PMPK)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

VO2 uptake - level ground

VO2 uptake during ambulation on a treadmill - level ground

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

VO2 uptake - incline

VO2 uptake during ambulation on a treadmill - 5 degree incline

Time frame
Visit 2 (3 weeks post-study enrollment)

Secondary outcomes

1

Balance confidence

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

Time frame
At Baseline Visit (study enrollment)
2

Exertion

Borg Exertion Scale (0-10) with 10 being maximum exertion

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Loma Linda University

Lead sponsor

Össur Iceland ehf

Collaborator

Source ClinicalTrials.gov
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