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

History of Changes

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:

MedlinePlus related topics: Foot Health

U.S. FDA Resources

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 May 23, 2013

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