Personalizing MPK Prescription

Personalizing MPK Prescription for Individuals With Transfemoral Amputation

In current clinical prosthetic practice, there is no evidence based method for selecting a microprocessor knee (MPK) joint for a patient with an above the knee amputation. Of individuals with amputation in veteran and service member populations, approximately 35% present with an above the knee amputation. It is well understood in clinical practice that MPKs provide numerous benefits to patients with amputations above the knee including improved gait, safety, comfort, confidence, reduced falls, balance, patient satisfaction and reduced energy expenditure, greater ease in negotiating varying terrains, improvements in multi-tasking and cost effectiveness. Studies that have investigated commercially available MPKs tend to lump all of them together within a single group rather than teasing out individual differences between each knee. Therefore, clinicians are left to rely on their own intuition and past experiences with an MPK when selecting for a patient with an above the knee amputation rather than making their decision based on evidence collected from the specific patient. This may mean that some individuals with an above the knee amputation may not be receiving the best component for them which may delay or inhibit their rehabilitation potential following their amputation.

Study Overview

• Status: Completed
• Conditions: Transfemoral Amputation
• Intervention / Treatment: Device: Microprocessor prosthetic knee

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30332
      • Georgia Institute of Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• A unilateral transfemoral amputation of the lower limb at least six months post fitting of definitive lower extremity prosthesis
• Habitual use of a lower extremity prosthesis in daily living activities (based on assessment of a physiatrist and/or prosthetist and patient self-report)
• Aged between 18 to 75 years
• K3 or K4 level ambulators who can perform all locomotor tasks of interest (based on assessment of a physiatrist and/or prosthetist)

Exclusion Criteria:

• Individuals with any significant neuromuscular or musculoskeletal disorder or other comorbidity that would interfere with participation (based on assessment of the physiatrist and/or prosthetist and patient self-report)
• Individuals who have open wounds on their residual limb
• Individuals with known visual impairments that would prevent them from safely operating a prosthesis during over ground walking or ascending stairs (based on assessment of the physiatrist and/or prosthetist and patient self-report)
• Individuals with known hearing impairments or who use hearing aids that would prevent them from responding to an auditory instruction (based on assessment of the physiatrist and/or prosthetist and patient self-report)
• Individuals who are currently pregnant (based on patient self-report) due to slight risk of falling during experiments

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Microprocessor Prosthetic Knee; Randomization to C-Leg 4.0, Rheo Knee and Power Knee	Device: Microprocessor prosthetic knee; Microprocessor prosthetic knees for use in a transfemoral prosthesis; Other Names: Power Knee; C-Leg; Rheo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ten Meter Walking Test	Self selected walking speed over ten meters of walking over ground.	1 month
Two Minute Walking Test	Self selected walking speed over two minutes of walking over ground.	1 month
Prosthetic Evaluation Questionnaire (PEQ)	A patient reported survey on perceptions of a prosthesis. Scores range zero to one hundred with zero being representing a negative patient reported outcome and one hundred representing a positive patient reported outcome.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stance Time Asymmetry Index	Stance time asymmetry index measures the percent difference in stance time between the prosthetic and sound side limbs. A value equal to zero is indicative of perfect symmetry. Negative values of ST asymmetry index are indicative of increased time spent on the sound side and positive values are indicative of increased time on the prosthetic side.	1 month
Narrowing Beam Walking Test	A measure of balance via walking down a narrowing beam.	1 month
Reported Falls	Average reported falls per day.	1 month
Physiological Cost Index	A clinical measure of energy expenditure. This formula consists of working heart minus resting heart rate divided by speed.	1 month
Stair Ascent Speed	Self selected walking speed during stair ascent.	1 month
Stair Descent Speed	Self selected walking speed while descending stairs.	1 month
Ramp Ascent Speed	Self selected walking speed while ascending a 5 degree incline.	1 month
Ramp Descent Speed	Self selected walking speed while descending a 5 degree incline.	1 month
Steps Per Day	Steps per day as measured by StepWatch.	1 month

Collaborators and Investigators

• Sponsor: Georgia Institute of Technology

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2021
• Primary Completion (Actual): October 2, 2023
• Study Completion (Actual): October 2, 2023

Study Registration Dates

• First Submitted: May 1, 2024
• First Submitted That Met QC Criteria: May 1, 2024
• First Posted (Actual): May 3, 2024

Study Record Updates

• Last Update Posted (Estimated): November 14, 2024
• Last Update Submitted That Met QC Criteria: November 8, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: H21008; W81XWH-21-1-0686 (Other Grant/Funding Number: Department of Defense Congressionally Directed Medical Research Program)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No