AmputationNCT02366702

Kinematic, Kinetic, and Metabolic Comparison of Bilateral Transfemoral Ambulation With Passive Versus Powered Prosthetic Devices

An observational study of Amputation and Artificial Limbs, run by Southern California Institute for Research and Education at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 to 45 years
Conditions the study is for: Amputation, Artificial Limbs, Energy Expenditure
What is being tested?: Lower Limb Powered Knee-Ankle Prosthesis
Type of treatment: Medical device
How many people: 3 participants
Where: 1 siteUnited States
Study dates: Feb 2015to Feb 2020
Phase: Observational
Are there results?: None posted in the registry

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 45 years
All sexes
No healthy volunteers
Adult

Study population: Individuals with bilateral transfemoral amputation who are community level ambulators. Individuals are ambulatory with non-powered prosthetic devices.

Who may be able to join

Male or female
All causes of limb amputation: congenital, trauma, vascular, limb salvage, infection.
All transfemoral residual limb lengths: joint disarticulation, long, medium, short, very short.
Subjects currently walk with entirely passive type prostheses daily.
Subjects walk without assistive devices OR with single point cane.
High-activity level walkers

Who cannot join

Ages < 18 or > 45 years
Medical comorbidities or existing conditions that may impede the subjects ability to complete the protocol excluding the amputations.
Current medications or pharmaceutical interventions that may impede the subjects ability to complete the protocol.
Any powered prosthetic component or prosthesis, including but not exclusive to: Ossur Proprio Foot, BiOM or BiOM T2 System Foot, Ossur Power Knee, Ossur Symbionic Leg.
Subjects requiring a walker, crutches, quad cane, or other assistive devices excluding a single point cane.
Low-activity level walkers

Trial locations and contacts

1 site in 1 country.

United States1 site

VA Long Beach Healthcare System
Long Beach, California, 90822

Other trials in United States

About this study

The purpose of this descriptive and exploratory pilot study is to investigate: (1) sagittal plane hip kinematics and kinetics and (2) metabolic consumption/cost, for bilateral transfemoral walking with passive prostheses versus powered prostheses. The pilot study will collect data from three subjects with bilateral transfemoral amputations. Differences in kinetics, kinematics, and oxygen consumption/cost when comparing passive and powered components may indicate benefits for clinical application of powered devices for persons with lower limb amputation.

Conditions: Amputation, Artificial Limbs, Energy Expenditure, Kinetics
Being tested: Lower Limb Powered Knee-Ankle Prosthesis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lower Limb Powered Knee-Ankle ProsthesisDevice

Study groups in NCT02366702
Study group	Role	What they receive
Individuals with Bilateral Transfemoral Amputation		Not described Receives: Device: Lower Limb Powered Knee-Ankle Prosthesis

What is being measured

The primary outcome is the main question the study is designed to answer.

Sagittal Plane Hip Moment
Measured: During the stance phase of the gait cycle after two weeks of training with powered device.
Metabolic Cost of Transport
Measured: 5 minutes of steady state walking after two weeks of training with powered device.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2015Feb 2020

First posted19 Feb 2015 (estimated)
Study startFeb 2015
Primary completionFeb 2017
Study completionFeb 2020 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (52)Papers the sponsor has linked to this study.
Other trials for 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: Observational
Observational model: Case crossover
Time perspective: Prospective
Enrolment: 3 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02366702
Sponsor's protocol ID: 01329
Status last verified: Apr 2019
First submitted: 12 Feb 2015
Last updated: 5 Apr 2019
Results posted: No
Data monitoring committee: No

Publications

Ziegler-Graham K, MacKenzie EJ, Ephraim PL, Travison TG, Brookmeyer R. Estimating the prevalence of limb loss in the United States: 2005 to 2050. Arch Phys Med Rehabil. 2008 Mar;89(3):422-9. doi: 10.1016/j.apmr.2007.11.005.
PubMed 18295618
Adams PF, Hendershot GE, Marano MA; Centers for Disease Control and Prevention/National Center for Health Statistics. Current estimates from the National Health Interview Survey, 1996. Vital Health Stat 10. 1999 Oct;(200):1-203.
PubMed 15782448
Feinglass J, Brown JL, LoSasso A, Sohn MW, Manheim LM, Shah SJ, Pearce WH. Rates of lower-extremity amputation and arterial reconstruction in the United States, 1979 to 1996. Am J Public Health. 1999 Aug;89(8):1222-7. doi: 10.2105/ajph.89.8.1222.
PubMed 10432910
Dougherty PJ, McFarland LV, Smith DG, Reiber GE. Combat-incurred bilateral transfemoral limb loss: a comparison of the Vietnam War to the wars in Afghanistan and Iraq. J Trauma Acute Care Surg. 2012 Dec;73(6):1590-5. doi: 10.1097/TA.0b013e318265fe64.
PubMed 23032809
Kurdibaylo SF. Obesity and metabolic disorders in adults with lower limb amputation. J Rehabil Res Dev. 1996 Oct;33(4):387-94.
PubMed 8895133
Wu YJ, Chen SY, Lin MC, Lan C, Lai JS, Lien IN. Energy expenditure of wheeling and walking during prosthetic rehabilitation in a woman with bilateral transfemoral amputations. Arch Phys Med Rehabil. 2001 Feb;82(2):265-9. doi: 10.1053/apmr.2001.19019.
PubMed 11239324
Su PF, Gard SA, Lipschutz RD, Kuiken TA. Gait characteristics of persons with bilateral transtibial amputations. J Rehabil Res Dev. 2007;44(4):491-501. doi: 10.1682/jrrd.2006.10.0135.
PubMed 18247246
Martinez-Villalpando EC, Herr H. Agonist-antagonist active knee prosthesis: a preliminary study in level-ground walking. J Rehabil Res Dev. 2009;46(3):361-73.
PubMed 19675988
Hoffman MD, Sheldahl LM, Buley KJ, Sandford PR. Physiological comparison of walking among bilateral above-knee amputee and able-bodied subjects, and a model to account for the differences in metabolic cost. Arch Phys Med Rehabil. 1997 Apr;78(4):385-92. doi: 10.1016/s0003-9993(97)90230-6.
PubMed 9111458
Quintero HA, Farris RJ, Ha K, Goldfarb M. Preliminary assessment of the efficacy of supplementing knee extension capability in a lower limb exoskeleton with FES. Annu Int Conf IEEE Eng Med Biol Soc. 2012;2012:3360-3. doi: 10.1109/EMBC.2012.6346685.
PubMed 23366646
Lawson BE, Huff A, Goldfarb M. A preliminary investigation of powered prostheses for improved walking biomechanics in bilateral transfemoral amputees. Annu Int Conf IEEE Eng Med Biol Soc. 2012;2012:4164-7. doi: 10.1109/EMBC.2012.6346884.
PubMed 23366845
Highsmith, M. J., Kahle, J. T., Carey, S. L., Lura, D. J., Dubey, R. V., & Quillen, W. S. (2010). Kinetic differences using a power knee and C-Leg while sitting down and standing up: a case report. JPO: Journal of Prosthetics and Orthotics, 22(4), 237-243
Wolf, E. J., & Pruziner, A. L. (2014). Use of a Powered Versus a Passive Prosthetic System for a Person with Bilateral Amputations during Level-Ground Walking. JPO: Journal of Prosthetics and Orthotics, 26(3), 166-170
Wolf EJ, Everding VQ, Linberg AA, Czerniecki JM, Gambel JM. Comparison of the Power Knee and C-Leg during step-up and sit-to-stand tasks. Gait Posture. 2013 Jul;38(3):397-402. doi: 10.1016/j.gaitpost.2013.01.007. Epub 2013 Jan 30.
PubMed 23375018
Barr AE, Siegel KL, Danoff JV, McGarvey CL 3rd, Tomasko A, Sable I, Stanhope SJ. Biomechanical comparison of the energy-storing capabilities of SACH and Carbon Copy II prosthetic feet during the stance phase of gait in a person with below-knee amputation. Phys Ther. 1992 May;72(5):344-54. doi: 10.1093/ptj/72.5.344.
PubMed 1631203

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Kinematic, Kinetic, and Metabolic Comparison of Bilateral Transfemoral Ambulation With Passive Versus Powered Prosthetic Devices
ClinicalTrials.gov ID: NCT02366702
Acronym / sponsor ID: 01329
Conditions: Amputation, Artificial Limbs, Energy Expenditure, Kinetics
Study type: Observational
Recruitment status: Unknown status
Enrolment: 3 participants (actual)
Lead sponsor: Southern California Institute for Research and EducationUniversity, hospital or other
Collaborators: Vanderbilt University
Study start: Feb 2015 (actual)
Primary completion: Feb 2017 (actual)
Study completion: Feb 2020 (estimated)
First posted: 19 Feb 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case crossover
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Individuals with Bilateral Transfemoral Amputation	–	Device: Lower Limb Powered Knee-Ankle Prosthesis

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult
Study population: Individuals with bilateral transfemoral amputation who are community level ambulators. Individuals are ambulatory with non-powered prosthetic devices.

Key inclusion criteria (6 listed)

Male or female
All causes of limb amputation: congenital, trauma, vascular, limb salvage, infection.
All transfemoral residual limb lengths: joint disarticulation, long, medium, short, very short.
Subjects currently walk with entirely passive type prostheses daily.
Subjects walk without assistive devices OR with single point cane.

Key exclusion criteria (6 listed)

Ages < 18 or > 45 years
Medical comorbidities or existing conditions that may impede the subjects ability to complete the protocol excluding the amputations.
Current medications or pharmaceutical interventions that may impede the subjects ability to complete the protocol.
Any powered prosthetic component or prosthesis, including but not exclusive to: Ossur Proprio Foot, BiOM or BiOM T2 System Foot, Ossur Power Knee, Ossur Symbionic Leg.
Subjects requiring a walker, crutches, quad cane, or other assistive devices excluding a single point cane.

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
Lower Limb Powered Knee-Ankle Prosthesis	Device	Individuals with Bilateral Transfemoral Amputation

Primary outcome

Sagittal Plane Hip Moment
Time frame: During the stance phase of the gait cycle after two weeks of training with powered device.
Metabolic Cost of Transport
Time frame: 5 minutes of steady state walking after two weeks of training with powered device.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
Background: PubMed 18295618Ziegler-Graham K, MacKenzie EJ, Ephraim PL, Travison TG, Brookmeyer R. Estimating the prevalence of limb loss in the United States: 2005 to 2050. Arch Phys Med Rehabil. 2008 Mar;89(3):422-9. doi: 10.1016/j.apmr.2007.11.005.
Background: PubMed 15782448Adams PF, Hendershot GE, Marano MA; Centers for Disease Control and Prevention/National Center for Health Statistics. Current estimates from the National Health Interview Survey, 1996. Vital Health Stat 10. 1999 Oct;(200):1-203.
Background: PubMed 10432910Feinglass J, Brown JL, LoSasso A, Sohn MW, Manheim LM, Shah SJ, Pearce WH. Rates of lower-extremity amputation and arterial reconstruction in the United States, 1979 to 1996. Am J Public Health. 1999 Aug;89(8):1222-7. doi: 10.2105/ajph.89.8.1222.
Background: PubMed 23032809Dougherty PJ, McFarland LV, Smith DG, Reiber GE. Combat-incurred bilateral transfemoral limb loss: a comparison of the Vietnam War to the wars in Afghanistan and Iraq. J Trauma Acute Care Surg. 2012 Dec;73(6):1590-5. doi: 10.1097/TA.0b013e318265fe64.
Background: PubMed 8895133Kurdibaylo SF. Obesity and metabolic disorders in adults with lower limb amputation. J Rehabil Res Dev. 1996 Oct;33(4):387-94.
Background: PubMed 11239324Wu YJ, Chen SY, Lin MC, Lan C, Lai JS, Lien IN. Energy expenditure of wheeling and walking during prosthetic rehabilitation in a woman with bilateral transfemoral amputations. Arch Phys Med Rehabil. 2001 Feb;82(2):265-9. doi: 10.1053/apmr.2001.19019.
Background: PubMed 18247246Su PF, Gard SA, Lipschutz RD, Kuiken TA. Gait characteristics of persons with bilateral transtibial amputations. J Rehabil Res Dev. 2007;44(4):491-501. doi: 10.1682/jrrd.2006.10.0135.
Background: PubMed 19675988Martinez-Villalpando EC, Herr H. Agonist-antagonist active knee prosthesis: a preliminary study in level-ground walking. J Rehabil Res Dev. 2009;46(3):361-73.
Background: PubMed 9111458Hoffman MD, Sheldahl LM, Buley KJ, Sandford PR. Physiological comparison of walking among bilateral above-knee amputee and able-bodied subjects, and a model to account for the differences in metabolic cost. Arch Phys Med Rehabil. 1997 Apr;78(4):385-92. doi: 10.1016/s0003-9993(97)90230-6.
Background: PubMed 23366646Quintero HA, Farris RJ, Ha K, Goldfarb M. Preliminary assessment of the efficacy of supplementing knee extension capability in a lower limb exoskeleton with FES. Annu Int Conf IEEE Eng Med Biol Soc. 2012;2012:3360-3. doi: 10.1109/EMBC.2012.6346685.
Background: PubMed 23366845Lawson BE, Huff A, Goldfarb M. A preliminary investigation of powered prostheses for improved walking biomechanics in bilateral transfemoral amputees. Annu Int Conf IEEE Eng Med Biol Soc. 2012;2012:4164-7. doi: 10.1109/EMBC.2012.6346884.
BackgroundHighsmith, M. J., Kahle, J. T., Carey, S. L., Lura, D. J., Dubey, R. V., & Quillen, W. S. (2010). Kinetic differences using a power knee and C-Leg while sitting down and standing up: a case report. JPO: Journal of Prosthetics and Orthotics, 22(4), 237-243

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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.

Michael Goldfarb, Ph.D. principal investigator

Vanderbilt University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Amputation and Artificial Limbs, run by Southern California Institute for Research and Education 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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 5 Apr 2019. 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.

Are results available for this study?

Results are not available in the source record.

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?

Sagittal Plane Hip Moment (time frame: During the stance phase of the gait cycle after two weeks of training with powered device.). The study lists 2 primary outcomes in all. 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 NCT02366702, which also lists 52 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 5 Apr 2019.