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Completed

NCT Number: NCT02864693

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

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.

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Key information

Conditions

Amputation

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ability Prosthetics and Orthotics, Inc. - Hagerstown, MD, Hagerstown, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kinnex

Device

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

Pacifica LP

Device

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

Primary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

Secondary outcomes

  1. Orthotic Prosthetic User Survey (OPUS)

    Time frame: Collection after 4 weeks

    The OPUS is a self-reported questionnaire that asks about satisfaction with device

  2. 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

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Ability Prosthetics and Orthotics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Aug 12, 2016
Registry last updated
Jul 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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