Comparative Effectiveness of Microprocessor Controlled and Carbon Fiber Prosthetic Feet in Transtibial Amputees

Comparative Effectiveness of Microprocessor Controlled and Carbon Fiber Energy Storing and Returning Prosthetic Feet in Persons With Unilateral Transtibial Amputation

The purpose of this research is to evaluate benefits of a microprocessor controlled prosthetic ankle-foot device compared to a non-microprocessor controlled or passive carbon fiber prosthetic ankle-foot device.

Study Overview

• Status: Completed
• Conditions: Amputation
• Intervention / Treatment: Device: Kinnex; Device: Pacifica LP

Detailed Description

Recent advancements in microprocessor controlled prosthetic ankle-foot systems have allowed additional functionality for the lower limb amputee, but research into the effectiveness of microprocessor controlled ankle-foot systems has been limited.

In this research study, differences in perceived mobility, functional capabilities and gait parameters between energy storing and returning and microprocessor controlled ankle-foot mechanisms will be identified where they exist. Also a comparison of the initial function with a new system compared to the function after a four week accommodation period will provide insight into the time it takes for the prosthesis user to experience a benefit from a microprocessor ankle-foot.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Hagerstown, Maryland, United States, 21740
      • Ability Prosthetics and Orthotics, Inc. - Hagerstown, MD
  • North Carolina
    • Charlotte, North Carolina, United States, 28211
      • Ability Prosthetics and Orthotics, Inc. - Charlotte, NC
  • Pennsylvania
    • York, Pennsylvania, United States, 17403
      • Ability Prosthetics and Orthotics, Inc. - York, PA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Unilateral transtibial amputation
• Age 18-99 years old
• Body weight below 275 lbs
• Non-pregnant
• English speaking
• Current user of prosthesis for at least one year
• Wear time 8 hrs/day or more
• MFCL ≥ K-3
• Well-fitting and functioning prosthesis
• No use of ambulatory aide
• Able to tolerate testing protocol
• Able to walk on slopes
• Must, in the opinion of the investigator, be willing and able to complete all aspects of the study, adhere to the study visit schedule and comply with the assessments

Exclusion Criteria:

• Amputation level other than unilateral transtibial
• Age <18 or >99 years old
• Body weight above 275 lbs
• Pregnant
• Non-English speaking
• Not current user of prosthesis
• Less than one year use of prosthesis
• Wear time less than 8 hr/day
• MFCL <K3
• Poor fitting and functioning prosthesis
• Indicating that the socket fit is painful, or unacceptable
• Use of ambulatory aide
• Unable to tolerate testing protocol
• Unable to walk on slopes
• Presence or history of any condition that, in the view of the investigator, places the participant at high risk of poor treatment compliance or of not completing the study
• Any neurologic impairments known to cause gait and/or balance dysfunction

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Configuration A (Kinnex)	Device: Kinnex; The Kinnex is a microprocessor controlled hydraulic ankle foot device (Freedom Innovations, Irvine, CA).
Active Comparator: Configuration B (Pacifica LP)	Device: Pacifica LP; The Pacifica LP is a carbon-fiber ankle foot device (Freedom Innovations, Irvine, CA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amputee Mobility Predictor with Prosthesis (AMPPRO)	The AMPPRO is a functional test consisting of 21 tasks that are similar to everyday function to test balance, strength and walking ability	Collection at baseline
L-Functional Test (L-Test) Baseline	The L-test is a timed functional test that involves standing from a chair, walking 3 meters, turning around and sitting back into the chair.	Collection at baseline
5 times Sit-to-Stand (5 times STS) Baseline	The 5 times STS is a timed functional test that measures how long it takes to stand and sit five times in a row from a chair.	Collection at baseline
6 minute Timed Walk Test (6m TWT) Baseline	The 6m TWT involves walking as far as possible along a straight path between two cones in under 6 minutes.	Collection at baseline
Physiological Cost Index (PCI) Baseline	The PCI is calculated by subtracting resting heart rate from active heart rate following a walking test, and dividing the difference by the walking speed.	Collection at baseline
Hill Assessment Index (HAI) Baseline	The HAI is a functional test that measures quality of walking up and down a sloped ramp.	Collection at baseline
2 Dimensional Video Motion Analysis (2D Video Analysis) Baseline	2D Video Analysis will be used to measure knee and ankle angles at mid-stance of gait while walking up and down the sloped ramp and also while standing still on level ground.	Collection at baseline
L-Functional Test (L-Test) after 4 weeks	The L-test is a timed functional test that involves standing from a chair, walking 3 meters, turning around and sitting back into the chair.	Collection after 4 weeks
5 times Sit-to-Stand (5 times STS) after 4 weeks	The 5 times STS is a timed functional test that measures how long it takes to stand and sit five times in a row from a chair.	Collection after 4 weeks
6 minute Timed Walk Test (6m TWT) after 4 weeks	The 6m TWT involves walking as far as possible along a straight path between two cones in under 6 minutes.	Collection after 4 weeks
Physiological Cost Index (PCI) after 4 weeks	The PCI is calculated by subtracting resting heart rate from active heart rate following a walking test, and dividing the difference by the walking speed.	Collection after 4 weeks
Hill Assessment Index (HAI) after 4 weeks	The HAI is a functional test that measures quality of walking up and down a sloped ramp.	Collection after 4 weeks
2 Dimensional Video Motion Analysis (2D Video Analysis) after 4 weeks	2D Video Analysis will be used to measure knee and ankle angles at mid-stance of gait while walking up and down the sloped ramp and also while standing still on level ground.	Collection after 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Orthotic Prosthetic User Survey (OPUS)	The OPUS is a self-reported questionnaire that asks about satisfaction with device	Collection after 4 weeks
Prosthesis Evaluation Questionnaire - Mobility Subscale (PEQ-MS)	The PEQ-MS is a self-reported questionnaire that measures perceived difficulty ambulating on a variety of environmental barriers	Collection after 4 weeks
Prosthesis Limb User Survey of Mobility (PLUS-M)	The PLUS-M is a self-reported questionnaire that measures perceived mobility with a prosthesis in different environments.	Collection after 4 weeks
Activities-Specific Balance Confidence Scale (ABC)	The ABC is a self-reported questionnaire that measures confidence in balance while performing various activities in different environments.	Collection after 4 weeks
Socket Comfort Score (SCS)	The SCS is a self-reported questionnaire that asks the participant to rate their current socket comfort from 0-10, with 10 points representing the most comfortable socket they can imagine.	Collection at baseline and after 4 weeks

Collaborators and Investigators

• Sponsor: Ability Prosthetics and Orthotics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: August 4, 2016
• First Submitted That Met QC Criteria: August 9, 2016
• First Posted (Estimate): August 12, 2016

Study Record Updates

• Last Update Posted (Actual): July 10, 2018
• Last Update Submitted That Met QC Criteria: July 9, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Microprocessor Controlled Ankle; Transtibial Amputee; Pacifica LP; Kinnex
• Other Study ID Numbers: FI-001

Plan for Individual participant data (IPD)

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