- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00494143
Metabolic Cost Savings for Transtibial Amputees Wearing the Controlled Energy Storage and Return (CESR) Foot
May 21, 2014 updated by: US Department of Veterans Affairs
Metabolic Cost Savings for Transtibial Amputees Walking With the CESR Foot
To determine if below-knee amputees will walk with better efficiency wearing a CESR foot which stores energy at heel strike and releases energy releases energy during push-off.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Amputees work harder and have greater oxygen cost during ambulation compared to those without limb loss.
Therefore, amputees generally walk slower and tire more easily than intact individuals.
The loss of the ankle as a propulsive and supportive joint requires the amputee to perform extra muscular work with the hip, trunk and contralateral limb during ambulation.
This increased muscular activity consumes additional metabolic energy and means that amputees have to work harder to walk at the same speed as intact individuals.
For some amputees, this extra effort is simply not possible, and their loss of functional ambulation leads to a progressive spiral of disuse, reduced capacity and more disuse.
Conversely, greater mobility can lead to greater activity and even more successful return to the workplace.
The health consequences for amputees who do not maintain functional ambulation is multifactorial and costly, not only in terms of dollars for the institutions committed to their care, but also for the individuals themselves in terms of decreased quality of life, increased disability and pain.
Recent developments have resulted in the design of a novel prosthetic foot that uses the energy from compressive forces during heel contact, stores it throughout midstance and releases it at an optimal instant during push-off in late stance.
This unique design, with Controlled Energy Storage and Release (CESR) developed by a team at the University of Michigan, Ann Arbor has been shown to reduce the metabolic cost penalty of prosthetic ambulation (i.e. the increased cost over normal walking) by 50% compared to a standard SACH foot, but as yet only intact individuals wearing an aircast boot equipped with the prosthetic feet have been studied.
It is likely that the increased energy savings will also be observed in transtibial amputees.
Young, active amputees will soon be entering the VA system following operations in Iraq and Afghanistan, and the energy improvements may benefit this new VA patient population.
The CESR foot may also provide substantial metabolic cost savings to older less active amputees currently in the VA system.
By improving gait efficiency amputees will be better able to keep up with the demands of functional ambulation, remain more active and postpone many of the debilitating consequences of limited mobility.
Therefore we propose to first refine the design of the CESR foot focusing on the energy storage and energy release mechanisms of the CESR foot.
Several spring characteristics may prove optimal for certain subjects depending upon weight and walking characteristics.
This will be an iterative optimization process with power generation and absorption characteristics of the CESR foot evaluated using computerized gait analysis and the lessons used for further refinement.
The second phase will involve a three week wear-testing trial to determine if any improvement in gait economy, reduction in fatigue, improvement in comfort, or increase in the amount of daily walking can be achieved.
A validated questionnaire will be utilized to determine each amputee's comfort and fatigue during a three week trial in their conventional foot and with the CESR foot.
Step counts will be performed on each individual over the entire 3 week period with both the conventional foot and with the CESR foot.
We will collect full body gait kinematics (motion) and kinetics (forces) using our Vicon 612 system, and metabolic measurements using our VmaxST to calculate oxygen cost for 24 transtibial amputees while walking with the CESR foot and their conventional foot.
This will permit the calculation of the energy storage and release of the foot by inverse dynamics and calculate the net effect upon metabolic energy cost savings during ambulation at several speeds.
If the CESR foot is successful in amputee gait these domains, our next step will be to perform a multi-center study with other VA motion laboratories, and eventually collaborate with Ohio Willow Wood, a prominent prosthetic manufacturer who has expressed an interest in bringing the CESR foot to market.
Study Type
Interventional
Enrollment (Actual)
7
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Washington
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Seattle, Washington, United States, 98108
- VA Puget Sound Health Care System, Seattle
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Transtibial Amputees > 1 year walking with prosthesis
- Non-amputee control subjects
Exclusion Criteria:
- Additional musculoskeletal pathology
- Cognitive limitation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Conventional Prosthetic foot
A conventional prosthetic foot that has limited energy storage and return capabilities.
It is standardized and used by all subjects in the study.
|
patients will wear the prosthetic foot that they were prescribed by the care providers in the clinical team
|
Active Comparator: Prescribed Prosthetic foot
the Prosthetic foot that the subject had prescribed for them by their clinical providers and was worn prior to study initiation
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a standard foot that has had weights applied to match the mass of the CESR foot
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Experimental: CESR foot
the experimental CESR, controlled energy storage prosthetic foot
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a novel prosthetic foot that is designed to store energy and release it at a predetermined time in the gait cycle
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Metabolic Oxygen Consumption During Ambulation
Time Frame: Subjects were oriented to the testing protocol and each prosthetic foot on average 5 days prior to data collection and a acclimatization period of 5-10 minutes with each prosthetic foot prior to data collection
|
VO2 was collected at rest and while walking at a controlled walking speed of 1.14 meters/second for 10 minutes until they reached a steady state for 3 minutes.
This was repeated for each foot condition.
VO2 at the steady state was recorded in ml/min and were subsequently converted to calories and and then to Watts.
The data were then corrected for body weight by dividing by weight in Kg.
The gross VO2 in Watts/Kg during walking were then adjusted to net VO2 in Watts/kg by subtracting the resting metabolic rate.
|
Subjects were oriented to the testing protocol and each prosthetic foot on average 5 days prior to data collection and a acclimatization period of 5-10 minutes with each prosthetic foot prior to data collection
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prosthetic Foot Push Off Peak Power
Time Frame: Subjects were oriented to the testing protocol and each prosthetic foot on average 5 days prior to data collection and a acclimatization period of 5-10 minutes with each prosthetic foot prior to data collection
|
The biomechanical measurement of the power generated by the prosthetic foot during the push off component of stance phase.
The peak power output during the push off component of stance phase was calculated in Joules.
It was subsequently standardized for body weight in Kgs.
The final units were therefore Joules/Kg.
|
Subjects were oriented to the testing protocol and each prosthetic foot on average 5 days prior to data collection and a acclimatization period of 5-10 minutes with each prosthetic foot prior to data collection
|
Peak Intact Knee Loading
Time Frame: Subjects were oriented to the testing protocol and each prosthetic foot on average 5 days prior to data collection and a acclimatization period of 5-10 minutes with each prosthetic foot prior to data collection
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The biomechanical measure of the first peak of the knee external adduction moment
|
Subjects were oriented to the testing protocol and each prosthetic foot on average 5 days prior to data collection and a acclimatization period of 5-10 minutes with each prosthetic foot prior to data collection
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Joseph M. Czernieki, MD MS, VA Puget Sound Health Care System, Seattle
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Segal AD, Zelik KE, Klute GK, Morgenroth DC, Hahn ME, Orendurff MS, Adamczyk PG, Collins SH, Kuo AD, Czerniecki JM. The effects of a controlled energy storage and return prototype prosthetic foot on transtibial amputee ambulation. Hum Mov Sci. 2012 Aug;31(4):918-31. doi: 10.1016/j.humov.2011.08.005. Epub 2011 Nov 17.
- Morgenroth DC, Segal AD, Zelik KE, Czerniecki JM, Klute GK, Adamczyk PG, Orendurff MS, Hahn ME, Collins SH, Kuo AD. The effect of prosthetic foot push-off on mechanical loading associated with knee osteoarthritis in lower extremity amputees. Gait Posture. 2011 Oct;34(4):502-7. doi: 10.1016/j.gaitpost.2011.07.001. Epub 2011 Jul 30.
- Zelik KE, Collins SH, Adamczyk PG, Segal AD, Klute GK, Morgenroth DC, Hahn ME, Orendurff MS, Czerniecki JM, Kuo AD. Systematic variation of prosthetic foot spring affects center-of-mass mechanics and metabolic cost during walking. IEEE Trans Neural Syst Rehabil Eng. 2011 Aug;19(4):411-9. doi: 10.1109/TNSRE.2011.2159018. Epub 2011 Jun 23.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2007
Primary Completion (Actual)
May 1, 2009
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
June 28, 2007
First Submitted That Met QC Criteria
June 28, 2007
First Posted (Estimate)
June 29, 2007
Study Record Updates
Last Update Posted (Estimate)
June 9, 2014
Last Update Submitted That Met QC Criteria
May 21, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- A4372-R
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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