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Comparing Active and Passive Ankle-foot Prostheses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Paolo Bonato, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT01684501
First received: September 7, 2012
Last updated: September 12, 2012
Last verified: September 2012
History of Changes
  Purpose
The purpose of this study is to perform clinical testing of the PowerFoot in a group of individuals with trans-tibial amputation with the objective of optimizing its performance and comparing it with a current state-of-art passive-elastic ankle-foot prosthesis, i.e. the Ceterus Flex-Foot.

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:

MedlinePlus related topics: Foot Health
U.S. FDA Resources

Further study details as provided by Spaulding Rehabilitation Hospital:

Primary Outcome Measures:
  • Gait kinematics [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Kinematic gait parameters for level, ramp and stair ambulation

  • Energy consumption [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Metabolic consumption change between rest and walking conditions

  • Gait kinetics [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Kinetic gait parameters at different joint levels for level, ramp and stair ambulation
Enrollment: 6
Study Start Date: June 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Amputees
Adults with history of traumatic unilateral transtibial amputation

Detailed Description:

The investigators will measure performance during level ground walking and in simulated uneven terrain. The investigators will also compare the metabolic cost and self-selected gait speed with the PowerFoot versus the traditional Ceterus Flex-Foot.

Tasks will include:

  • Perform biomechanical analysis (kinematic and kinetic gait parameters) of the PowerFoot and the Ceterus in a group of individuals with trans-tibial amputation during level walking, ramp ambulation, and stair ambulation.
  • Compare in the laboratory and in the field the performance of the PowerFoot with the Ceterus.
  Eligibility
Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Genders Eligible for Study:   Both
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
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: NCT01684501

Locations
United States, Massachusetts
Spaulding Rehabilitation Hospital Boston
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
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 
Study First Received: September 7, 2012
Last Updated: September 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Spaulding Rehabilitation Hospital:
prosthesis
amputees
gait

ClinicalTrials.gov processed this record on September 29, 2016