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

NCT02864693 | Completed

• 1 other identifier: FI-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Amputation

Keywords

Microprocessor Controlled Ankle; Transtibial Amputee; Pacifica LP; Kinnex

Outcome Measures

Primary Outcomes (13)

• 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 Outcomes (5)

• Orthotic Prosthetic User Survey (OPUS)

  Collection after 4 weeks

• Prosthesis Evaluation Questionnaire - Mobility Subscale (PEQ-MS)

  Collection after 4 weeks

• Prosthesis Limb User Survey of Mobility (PLUS-M)

  Collection after 4 weeks

• Activities-Specific Balance Confidence Scale (ABC)

  Collection after 4 weeks

• Socket Comfort Score (SCS)

  Collection at baseline and after 4 weeks

Study Arms (2)

Configuration A (Kinnex)

ACTIVE COMPARATOR

Device: Kinnex

Configuration B (Pacifica LP)

ACTIVE COMPARATOR

Device: Pacifica LP

Interventions

Kinnex DEVICE

The Kinnex is a microprocessor controlled hydraulic ankle foot device (Freedom Innovations, Irvine, CA).

Configuration A (Kinnex)

Pacifica LP DEVICE

The Pacifica LP is a carbon-fiber ankle foot device (Freedom Innovations, Irvine, CA)

Configuration B (Pacifica LP)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ability Prosthetics and Orthotics, Inc.: lead

Study Sites (3)

Ability Prosthetics and Orthotics, Inc. - Hagerstown, MD

Hagerstown, Maryland, 21740, United States

Location

Ability Prosthetics and Orthotics, Inc. - Charlotte, NC

Charlotte, North Carolina, 28211, United States

Location

Ability Prosthetics and Orthotics, Inc. - York, PA

York, Pennsylvania, 17403, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Outcome and Research Director

Study Record Dates

• First Submitted: August 4, 2016
• First Posted: August 12, 2016
• Study Start: June 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: April 1, 2018
• Last Updated: July 10, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)