Characterizing Ankle Function During Sloped Locomotion for Prosthesis Development

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 30, 2014