Characterizing Ankle Function During Sloped Locomotion for Prosthesis Development

This study is currently recruiting participants.
Verified June 2012 by VA Eastern Colorado Health Care System
Sponsor:
Information provided by (Responsible Party):
VA Eastern Colorado Health Care System
ClinicalTrials.gov Identifier:
NCT01784003
First received: January 25, 2013
Last updated: February 1, 2013
Last verified: June 2012
  Purpose

The proposed study aims to characterize biological ankle joint function during walking and running on slopes in order to further develop advanced powered ankle-foot prostheses. Ankle joint torque and angle data will be collected from non-amputees while walking and running at multiple speeds and slopes. This data will be used to develop control parameters for a powered ankle-foot prosthesis. Then, these parameters will be implemented and tested in a powered prosthesis worn by people with below the knee amputations.


Condition Intervention
Traumatic Amputation of Lower Extremity
Device: Powered ankle-foot prosthesis

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Characterizing Ankle Function During Sloped Locomotion for Prosthesis Development

Resource links provided by NLM:


Further study details as provided by VA Eastern Colorado Health Care System:

Primary Outcome Measures:
  • Force-measuring treadmill and motion capture [ Time Frame: approximately 2 months ] [ Designated as safety issue: No ]
  • Metabolic analysis system [ Time Frame: approximately 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2012
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Non-amputee
People without an amputation will be recruited to participate in the study.
Below the knee amputee
People with a unilateral transtibial amputation will be recruited to participate in the study.
Device: Powered ankle-foot prosthesis

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Study 1: Non-amputee Study 2: Unilateral transtibial amputee Study 3: Unilateral transtibial amputee Study 4: Non-amputee Study 5: Unilateral transtibial amputee

Criteria

Inclusion Criteria:

Study 1:

- Between 18-60 years old.

Study 2 and 3:

  • Between 18-60 years old.
  • At least 1 year post-amputation
  • no current problems with prosthesis or residual limb
  • At least a K3 level of ambulation

Study 4:

- Between 18-45 years old

Study 5:

  • Between 18-45 years old
  • At least 1 year post-amputation
  • no current problems with prosthesis or residual limb
  • Experience running with a passive prosthesis
  • At least a K4 level of ambulation

Exclusion Criteria:

Studies 1-5

  • Cardiovascular, pulmonary, or neurological disease or disorder
  • Musculoskeletal injury
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01784003

Contacts
Contact: Alena Grabowski, PhD 303-492-5208 alena.grabowski@colorado.edu

Locations
United States, Colorado
University of Colorado Boulder Recruiting
Boulder, Colorado, United States, 80309
Contact: Alena Grabowski, PhD    303-492-5208    alena.grabowski@colorado.edu   
Principal Investigator: Alena Grabowski, PhD         
Sponsors and Collaborators
VA Eastern Colorado Health Care System
  More Information

No publications provided

Responsible Party: VA Eastern Colorado Health Care System
ClinicalTrials.gov Identifier: NCT01784003     History of Changes
Other Study ID Numbers: A7972W
Study First Received: January 25, 2013
Last Updated: February 1, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Amputation, Traumatic
Leg Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on April 22, 2014