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Comparing Active and Passive Ankle-foot Prostheses

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ClinicalTrials.gov Identifier: NCT01684501
Recruitment Status : Completed
First Posted : September 13, 2012
Last Update Posted : April 12, 2017
Sponsor:
Information provided by (Responsible Party):
Paolo Bonato, Spaulding Rehabilitation Hospital

Study Description
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Brief Summary:
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 or disease
Trans-tibial 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.

Study Design
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Study Type : Observational
Actual Enrollment : 6 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Comparing Active and Passive Ankle-foot Prostheses
Actual Study Start Date : May 2010
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

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U.S. FDA Resources

Groups and Cohorts
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Group/Cohort
Amputees
Adults with history of traumatic unilateral transtibial amputation


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 :
  1. Metabolic cost of ambulation [ Time Frame: During the session trial (approx 10 minutes) ]
    Oxygen consumption during level-ground walking


Eligibility Criteria
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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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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 Posted: September 13, 2012    Key Record Dates
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