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

Study Overview
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Brief Summary
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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
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The Procedures include: Initial Visit: Informed consent HIPAA authorization Determine/verify ambulation potential Take and record body measurements (height, weight, circumferences) Activities-Specific Balance Confidence (ABC) scale L.A.S.A.R. Posture alignment assessment with RxPx Second Visit Fit with heartrate monitor and metabolic analyzer mask Treadmill Test (level-ground) with RxPx Rest Treadmill Test (incline) with RxPx Fit subject with PMPK L.A.S.A.R. Posture alignment assessment with PMPK Subject uses PMPK for one week as their primary prosthesis Third Visit (1 week later) Fit with heartrate monitor and metabolic analyzer mask Treadmill Test (level-ground) with PMPK Rest Treadmill Test (incline) with PMPK Activities-Specific Balance Confidence (ABC) scale Return PMPK and refit of RxPx Verify alignment with L.A.S.A.R. Posture alignment Check that all fasteners are secure

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

Conditions
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Transfemoral Amputation

Intervention / Treatment
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* Other: Powered Microprocessor-controlled Knee (PMPK)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Participants will be their own control
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Powered Microprocessor-controlled Knee (PMPK)<br>the Power Knee is a commercially available PMPK. | Other: Powered Microprocessor-controlled Knee (PMPK)<br>* A microprocessor-controlled Knee with standardized commercial prosthetic foot<br>* Other names: Power Knee;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Balance confidence | Activities based balance confidence survey (0-100%) higher score means more balance confidence | At Baseline Visit (study enrollment) | 
| Exertion | Borg Exertion Scale (0-10) with 10 being maximum exertion | Change between Visit 2 (3 weeks post-study enrollment) and Visit 3 (4 weeks post-study enrollment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Power Knee, Amputation, Metabolic Costs, Heart Rate