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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
VA Eastern Colorado Health Care System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Amputation, Traumatic

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

First Posted
December 12, 2014
Last Updated
July 18, 2019
Sponsor
VA Eastern Colorado Health Care System
Collaborators
United States Department of Defense
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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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