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

Amputation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02864693
• Other study ID #: FI-001
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: April 2018

Study information

• Verified date: July 2018
• Source: Ability Prosthetics and Orthotics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2018
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Amputation

Intervention

Device:
• Kinnex
The Kinnex is a microprocessor controlled hydraulic ankle foot device (Freedom Innovations, Irvine, CA).
• Pacifica LP
The Pacifica LP is a carbon-fiber ankle foot device (Freedom Innovations, Irvine, CA)

Locations

Country	Name	City	State
United States	Ability Prosthetics and Orthotics, Inc. - Charlotte, NC	Charlotte	North Carolina
United States	Ability Prosthetics and Orthotics, Inc. - Hagerstown, MD	Hagerstown	Maryland
United States	Ability Prosthetics and Orthotics, Inc. - York, PA	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Ability Prosthetics and Orthotics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Orthotic Prosthetic User Survey (OPUS)	The OPUS is a self-reported questionnaire that asks about satisfaction with device	Collection after 4 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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