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Comparing Active and Passive Ankle-foot Prostheses
This study has been completed.
Sponsor:
Spaulding Rehabilitation Hospital
Information provided by (Responsible Party):
Paolo Bonato, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT01684501
First received: September 7, 2012
Last updated: April 10, 2017
Last verified: April 2017
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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| 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01684501
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
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 |
| Study First Received: | September 7, 2012 |
| Last Updated: | April 10, 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 |
ClinicalTrials.gov processed this record on September 21, 2017