Metabolic Cost Savings for Transtibial Amputees Wearing the Controlled Energy Storage and Return (CESR) Foot
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ClinicalTrials.gov Identifier: NCT00494143 |
Recruitment Status
:
Completed
First Posted
: June 29, 2007
Results First Posted
: June 9, 2014
Last Update Posted
: June 9, 2014
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Condition or disease | Intervention/treatment | Phase |
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Transtibial Amputation | Device: CESR Prosthetic Foot Device: typical prosthetic foot Device: standardized prosthetic foot | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 7 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Metabolic Cost Savings for Transtibial Amputees Walking With the CESR Foot |
Study Start Date : | July 2007 |
Actual Primary Completion Date : | May 2009 |
Actual Study Completion Date : | December 2012 |
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.
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Device: typical prosthetic foot
patients will wear the prosthetic foot that they were prescribed by the care providers in the clinical team
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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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Device: standardized prosthetic foot
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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Device: CESR Prosthetic Foot
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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- 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.
- 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.
- 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 ]The biomechanical measure of the first peak of the knee external adduction moment

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Transtibial Amputees > 1 year walking with prosthesis
- Non-amputee control subjects
Exclusion Criteria:
- Additional musculoskeletal pathology
- Cognitive limitation

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): NCT00494143
United States, Washington | |
VA Puget Sound Health Care System, Seattle | |
Seattle, Washington, United States, 98108 |
Principal Investigator: | Joseph M. Czernieki, MD MS | VA Puget Sound Health Care System, Seattle |
Publications of Results:
Responsible Party: | VA Office of Research and Development |
ClinicalTrials.gov Identifier: | NCT00494143 History of Changes |
Other Study ID Numbers: |
A4372-R |
First Posted: | June 29, 2007 Key Record Dates |
Results First Posted: | June 9, 2014 |
Last Update Posted: | June 9, 2014 |
Last Verified: | May 2014 |
Keywords provided by VA Office of Research and Development:
Amputee Economy Efficiency Foot |
Gait Kinematics Kinetics Prosthesis |