Transtibial AmputationPhase 3NCT00494143
Metabolic Cost Savings for Transtibial Amputees Wearing the Controlled Energy Storage and Return (CESR) Foot
A Phase 3 study testing CESR Prosthetic Foot, typical prosthetic foot and standardized prosthetic foot in people with Transtibial Amputation, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Transtibial Amputation
- What is being tested?
- CESR Prosthetic Foot, typical prosthetic foot and standardized prosthetic foot
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Dec 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Transtibial Amputees > 1 year walking with prosthesis
- Non-amputee control subjects
Who cannot join
- Additional musculoskeletal pathology
- Cognitive limitation
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System, Seattle
Seattle, Washington, 98108
About this study
Official title: 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.
Read the 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.
- Conditions
- Transtibial Amputation
- Being tested
- CESR Prosthetic Foot, typical prosthetic foot, standardized prosthetic foot
- Keywords
- Amputee, Economy, Efficiency, Foot, Gait, Kinematics, Kinetics, Prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CESR Prosthetic FootDevice
a novel prosthetic foot that is designed to store energy and release it at a predetermined time in the gait cycle
typical prosthetic footDevice
patients will wear the prosthetic foot that they were prescribed by the care providers in the clinical team
standardized prosthetic footDevice
a standard foot that has had weights applied to match the mass of the CESR foot
| Study group | Role | What they receive |
|---|---|---|
| Conventional Prosthetic foot | Active comparator | A conventional prosthetic foot that has limited energy storage and return capabilities. It is standardized and used by all subjects in the study. Receives: Device: typical prosthetic foot |
| Prescribed Prosthetic foot | Active comparator | the Prosthetic foot that the subject had prescribed for them by their clinical providers and was worn prior to study initiation Receives: Device: standardized prosthetic foot |
| CESR foot | Experimental | the experimental CESR, controlled energy storage prosthetic foot Receives: Device: CESR Prosthetic Foot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic Oxygen Consumption During Ambulation
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.
Measured: 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 outcomes (2)
Prosthetic Foot Push Off Peak Power
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.
Measured: 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
The biomechanical measure of the first peak of the knee external adduction moment
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2007 (estimated)
- Study startJul 2007
- Primary completionMay 2009
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Transtibial AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Collaborators
- University of Michigan
- Responsible party
- Sponsor
- Investigators
- Joseph M. Czernieki, MD MS, Principal investigator, VA Puget Sound Health Care System, Seattle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00494143
- Sponsor's protocol ID
- A4372-R
- Status last verified
- May 2014
- First submitted
- 28 Jun 2007
- Last updated
- 9 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 22100728Morgenroth 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.
PubMed 21803584Zelik 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.
PubMed 21708509
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Cost Savings for Transtibial Amputees Walking With the CESR Foot
- ClinicalTrials.gov ID
- NCT00494143
- Acronym / sponsor ID
- A4372-R
- Conditions
- Transtibial Amputation
- Keywords
- Amputee, Economy, Efficiency, Foot, Gait, Kinematics, Kinetics, Prosthesis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Collaborators
- University of Michigan
- Study start
- Jul 2007
- Primary completion
- May 2009 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 29 Jun 2007 (estimated)
- Results
- Posted 9 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional Prosthetic foot | Active comparator | Device: typical prosthetic footA conventional prosthetic foot that has limited energy storage and return capabilities. It is standardized and used by all subjects in the study. |
| Prescribed Prosthetic foot | Active comparator | Device: standardized prosthetic footthe Prosthetic foot that the subject had prescribed for them by their clinical providers and was worn prior to study initiation |
| CESR foot | Experimental | Device: CESR Prosthetic Footthe experimental CESR, controlled energy storage prosthetic foot |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Transtibial Amputees > 1 year walking with prosthesis
- Non-amputee control subjects
Key exclusion criteria (2 listed)
- Additional musculoskeletal pathology
- Cognitive limitation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CESR Prosthetic Foota novel prosthetic foot that is designed to store energy and release it at a predetermined time in the gait cycle | Device | CESR foot |
| typical prosthetic footpatients will wear the prosthetic foot that they were prescribed by the care providers in the clinical team | Device | Conventional Prosthetic foot |
| standardized prosthetic foota standard foot that has had weights applied to match the mass of the CESR foot | Device | Prescribed Prosthetic foot |
Primary outcome
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.
2 secondary outcomes
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22100728Segal 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.
- Results publication: PubMed 21803584Morgenroth 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.
- Results publication: PubMed 21708509Zelik 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.
Related trials for Transtibial Amputation
Active, not recruiting
Magnetic Bead Tracking System and eOPRA Implant System With Bionic Prosthesis for Transtibial Amputees
Amputation
Recruiting
Impact of Footwear on Gait in Unilateral Transtibial Amputees
Transtibial Amputation, Lower Limb Amputation
RecruitingPhase 1
Influence of Prosthetic Foot Stiffness on Transtibial Osseointegrated Bone-Anchored Limb Outcomes
Amputation, Transtibial Amputation - Unilateral
Recruiting
Transtibial Osseointegration
Amputation; Traumatic, Leg, Lower
Active, not recruitingEarly Phase 1
Feasibility Study Evaluating the Safety and Effectiveness of Magnetic Bead Tracking System When Used With a Bionic External Prosthesis
Transtibial Amputee, Transtibial Amputation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph M. Czernieki, MD MS principal investigator
VA Puget Sound Health Care System, Seattle
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CESR Prosthetic Foot, typical prosthetic foot and standardized prosthetic foot in people with Transtibial Amputation, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00494143, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2014.