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
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Condition or disease |
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Trans-tibial Amputation |
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 |
Group/Cohort |
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Amputees
Adults with history of traumatic unilateral transtibial amputation
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- Ankle power generation [ Time Frame: During the session trial (approx 10 minutes) ]Ankle power derived using a camera-based motion capture system during walking
- Metabolic cost of ambulation [ Time Frame: During the session trial (approx 10 minutes) ]Oxygen consumption during level-ground walking

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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 |
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

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
United States, Massachusetts | |
Spaulding Rehabilitation Hospital Boston | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | Paolo Bonato | Spaulding Rehabilitation Hospital |
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 |