What is the Optimal Stiffness and Height of a Running-specific Prosthesis?
Primary Purpose
Amputation, Traumatic, Traumatic Amputation of Lower Extremity, Wounds and Injuries
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Otto Bock prosthesis
Ossur prosthesis
Freedom Innovations prosthesis
Sponsored by
About this trial
This is an interventional basic science trial for Amputation, Traumatic
Eligibility Criteria
Inclusion Criteria:
- bilateral or unilateral transtibial amputation
- at least one year of running experience using running-specific prostheses
- 18-55 years old
- no current problems with their prosthesis or residual limb
- at a K4 Medicare Functional Classification Level
Exclusion Criteria:
- Cardiovascular, pulmonary, or neurological disease or disorder
Sites / Locations
- University of Colorado Boulder
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Running
Sprinting
Arm Description
Participants will run on an instrumented treadmill at one speed using three different prostheses.
Participants will run on an instrumented treadmill at a range of speeds from a jogging speed up to top speed.
Outcomes
Primary Outcome Measures
Biomechanics
The investigators will measure stance average vertical ground reaction forces during running and sprinting.
Secondary Outcome Measures
Metabolic Demand
The investigators will measure rates of oxygen consumption and carbon dioxide production during running to determine the optimal prosthesis for each participant.
Top Speed
The investigators will measure the top sprinting speed to determine the optimal prosthesis for each participant.
Full Information
NCT ID
NCT02318979
First Posted
December 12, 2014
Last Updated
July 18, 2019
Sponsor
VA Eastern Colorado Health Care System
Collaborators
United States Department of Defense
1. Study Identification
Unique Protocol Identification Number
NCT02318979
Brief Title
What is the Optimal Stiffness and Height of a Running-specific Prosthesis?
Official Title
What is the Optimal Stiffness and Height of a Running-specific Prosthesis?
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
October 2013 (Actual)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Eastern Colorado Health Care System
Collaborators
United States Department of Defense
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The proposed study aims to characterize the effects of running-specific leg prosthetic stiffness and height during on performance during running and sprinting to optimize running-specific prosthesis prescription. The investigators will collect biomechanical and metabolic data from participants with unilateral and bilateral below the knee amputations while they run at different speeds on a treadmill. This data will be used to understand the effects of running prostheses. Then, these parameters will be used to develop prosthetic prescription techniques for people with below the knee amputations.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amputation, Traumatic, Traumatic Amputation of Lower Extremity, Wounds and Injuries
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
10 athletes with a unilateral and 5 athletes with bilateral transtibial amputations used 15 different running-specific prosthetic configurations while they ran at one speed and we measured metabolic rates and biomechanics. 10 athletes with a unilateral and 5 athletes with bilateral transtibial amputations used 15 different running-specific prosthetic configurations while they ran at multiple speeds and we measured top speeds and biomechanics.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Running
Arm Type
Experimental
Arm Description
Participants will run on an instrumented treadmill at one speed using three different prostheses.
Arm Title
Sprinting
Arm Type
Experimental
Arm Description
Participants will run on an instrumented treadmill at a range of speeds from a jogging speed up to top speed.
Intervention Type
Device
Intervention Name(s)
Otto Bock prosthesis
Intervention Description
Participants will run using the Otto Bock prosthesis at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter.
Intervention Type
Device
Intervention Name(s)
Ossur prosthesis
Intervention Description
Participants will run using the Ossur prosthesis at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter.
Intervention Type
Device
Intervention Name(s)
Freedom Innovations prosthesis
Intervention Description
Participants will run using the Freedom Innovations prosthesis at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter.
Primary Outcome Measure Information:
Title
Biomechanics
Description
The investigators will measure stance average vertical ground reaction forces during running and sprinting.
Time Frame
4-10 days
Secondary Outcome Measure Information:
Title
Metabolic Demand
Description
The investigators will measure rates of oxygen consumption and carbon dioxide production during running to determine the optimal prosthesis for each participant.
Time Frame
4 days
Title
Top Speed
Description
The investigators will measure the top sprinting speed to determine the optimal prosthesis for each participant.
Time Frame
4-10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
bilateral or unilateral transtibial amputation
at least one year of running experience using running-specific prostheses
18-55 years old
no current problems with their prosthesis or residual limb
at a K4 Medicare Functional Classification Level
Exclusion Criteria:
Cardiovascular, pulmonary, or neurological disease or disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alena M Grabowski, PhD
Organizational Affiliation
VA Eastern Colorado Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Boulder
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80309
Country
United States
12. IPD Sharing Statement
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What is the Optimal Stiffness and Height of a Running-specific Prosthesis?
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