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Comparing Active and Passive Ankle-foot Prostheses

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01684501
First Posted: September 13, 2012
Last Update Posted: April 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Paolo Bonato, Spaulding Rehabilitation Hospital
  Purpose
The purpose of this study is to perform a biomechanical study of a prototype prosthetic foot and evaluate if it provides a physiological generation of power at the ankle in transtibial amputees. The prosthetic foot is a prototype system that generates power via actuators (i.e. robotic system).

Condition
Trans-tibial Amputation

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Comparing Active and Passive Ankle-foot Prostheses

Resource links provided by NLM:


Further study details as provided by Paolo Bonato, Spaulding Rehabilitation Hospital:

Primary Outcome Measures:
  • Ankle power generation [ Time Frame: During the session trial (approx 10 minutes) ]
    Ankle power derived using a camera-based motion capture system during walking


Secondary Outcome Measures:
  • Metabolic cost of ambulation [ Time Frame: During the session trial (approx 10 minutes) ]
    Oxygen consumption during level-ground walking


Enrollment: 6
Actual Study Start Date: May 2010
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Amputees
Adults with history of traumatic unilateral transtibial amputation

Detailed Description:
Subjects will be studied during level-ground walking. A camera-based motion capture system will be used to study the biomechanics of motion and evaluate if the pattern of ankle power generation by the prosthetic foot is physiological. In addition, the metabolic cost of ambulation will be monitored during walking at constant speed over a period of several minutes. The data will allow us to assess if the prosthetic foot leads to a decreased metabolic cost of ambulation compared to passive prosthetic feet.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults with history of traumatic unilateral transtibial amputation
Criteria

Inclusion Criteria:

  • weigh more than 200 lbs
  • are high level ambulators corresponding to levels E to F of the Special Interest Group of Amputee Medicine (SIGAM) mobility grade
  • have the ability to follow multi-step commands.

Exclusion Criteria:

  • score level D on the SIGAM mobility grade
  • have experienced 1 or more falls in the last month before the study
  • have a residual limb length which does not allow for seven inches clearance of bracket attachment for the PowerFoot
  • the residual limb must be stable in volume (no change in socket or socket padding in last 6 months) and without pain that limits function
  • the sound-side (contralateral) lower extremity must be free of impediments that affect gait, range of motion, or limb muscle activity
  • Any diagnosed cardiovascular, pulmonary, neurological, and/ or orthopedic conditions that would interfere with subject participation
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01684501


Locations
United States, Massachusetts
Spaulding Rehabilitation Hospital Boston
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
Investigators
Principal Investigator: Paolo Bonato Spaulding Rehabilitation Hospital
  More Information

Responsible Party: Paolo Bonato, Director, Motion Analysis Laboratory, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT01684501     History of Changes
Other Study ID Numbers: 2010-P-000951
First Submitted: September 7, 2012
First Posted: September 13, 2012
Last Update Posted: April 12, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Paolo Bonato, Spaulding Rehabilitation Hospital:
prosthesis
amputees
gait