NCT02318979

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 17, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

July 16, 2019

Completed
Last Updated

July 30, 2019

Status Verified

May 1, 2019

Enrollment Period

4.3 years

First QC Date

December 12, 2014

Results QC Date

May 20, 2019

Last Update Submit

July 18, 2019

Conditions

Amputation, TraumaticTraumatic Amputation of Lower ExtremityWounds and Injuries

Outcome Measures

Primary Outcomes (1)

  • Biomechanics

    The investigators will measure stance average vertical ground reaction forces during running and sprinting.

    4-10 days

Secondary Outcomes (2)

  • Metabolic Demand

    4 days

  • Top Speed

    4-10 days

Study Arms (2)

Running

EXPERIMENTAL

Participants will run on an instrumented treadmill at one speed using three different prostheses.

Device: Otto Bock prosthesisDevice: Ossur prosthesisDevice: Freedom Innovations prosthesis

Sprinting

EXPERIMENTAL

Participants will run on an instrumented treadmill at a range of speeds from a jogging speed up to top speed.

Device: Otto Bock prosthesisDevice: Ossur prosthesisDevice: Freedom Innovations prosthesis

Interventions

Otto Bock prosthesisDEVICE

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.

RunningSprinting
Ossur prosthesisDEVICE

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.

RunningSprinting
Freedom Innovations prosthesisDEVICE

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.

RunningSprinting

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • bilateral or unilateral transtibial amputation
  • at least one year of running experience using running-specific prostheses
  • years old
  • no current problems with their prosthesis or residual limb
  • at a K4 Medicare Functional Classification Level

You may not qualify if:

  • Cardiovascular, pulmonary, or neurological disease or disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Boulder

Boulder, Colorado, 80309, United States

Location

MeSH Terms

Conditions

Amputation, TraumaticWounds and Injuries

Results Point of Contact

Title
Judith Jung, DRI Executive Director
Organization
Denver Research Institute
Judith.Jung@dri-va.org
303-501-0540

Study Officials

  • Alena M Grabowski, PhD

    VA Eastern Colorado Health Care System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2014

First Posted

December 17, 2014

Study Start

October 1, 2013

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

July 30, 2019

Results First Posted

July 16, 2019

Record last verified: 2019-05

Locations

US(1)