Comparative Effectiveness of Microprocessor Controlled and Carbon Fiber Prosthetic Feet in Transtibial Amputees
NCT ID: NCT02864693
Last Updated: 2018-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2016-06-30
2018-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Configuration A (Kinnex)
Kinnex
The Kinnex is a microprocessor controlled hydraulic ankle foot device (Freedom Innovations, Irvine, CA).
Configuration B (Pacifica LP)
Pacifica LP
The Pacifica LP is a carbon-fiber ankle foot device (Freedom Innovations, Irvine, CA)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
99 Years
ALL
No
Sponsors
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Ability Prosthetics and Orthotics, Inc.
INDUSTRY
Responsible Party
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Brian Kaluf BSE, CP
Clinical Outcome and Research Director
Locations
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Ability Prosthetics and Orthotics, Inc. - Hagerstown, MD
Hagerstown, Maryland, United States
Ability Prosthetics and Orthotics, Inc. - Charlotte, NC
Charlotte, North Carolina, United States
Ability Prosthetics and Orthotics, Inc. - York, PA
York, Pennsylvania, United States
Countries
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Other Identifiers
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FI-001
Identifier Type: -
Identifier Source: org_study_id
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