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

July 9, 2018 updated by: Brian Kaluf BSE, CP, Ability Prosthetics and Orthotics, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Amputee Mobility Predictor with Prosthesis (AMPPRO)
Time Frame: Collection at baseline
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
Time Frame: Collection at 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
Time Frame: Collection at 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
Time Frame: Collection at 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
Time Frame: Collection at 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
Time Frame: Collection at 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
Time Frame: Collection at 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
Time Frame: Collection 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
Time Frame: Collection 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
Time Frame: Collection 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
Time Frame: Collection 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
Time Frame: Collection 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
Time Frame: Collection 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Orthotic Prosthetic User Survey (OPUS)
Time Frame: Collection after 4 weeks
The OPUS is a self-reported questionnaire that asks about satisfaction with device
Collection after 4 weeks
Prosthesis Evaluation Questionnaire - Mobility Subscale (PEQ-MS)
Time Frame: Collection after 4 weeks
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)
Time Frame: Collection after 4 weeks
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)
Time Frame: Collection after 4 weeks
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)
Time Frame: Collection at baseline and after 4 weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ability Prosthetics and Orthotics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 4, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 12, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 10, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FI-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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