Characterizing Ankle Function During Sloped Locomotion for Prosthesis Development

September 8, 2020 updated by: VA Eastern Colorado Health Care System
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Boulder, Colorado, United States, 80309
        • University of Colorado Boulder

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Force-measuring treadmill and motion capture
Time Frame: approximately 2 months
approximately 2 months
Metabolic analysis system
Time Frame: approximately 2 months
approximately 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Eastern Colorado Health Care System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

September 1, 2020

Study Completion (Actual)

September 1, 2020

Study Registration Dates

First Submitted

January 25, 2013

First Submitted That Met QC Criteria

February 1, 2013

First Posted (Estimate)

February 5, 2013

Study Record Updates

Last Update Posted (Actual)

September 10, 2020

Last Update Submitted That Met QC Criteria

September 8, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A7972W

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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