AmputationPhase 3NCT00968292
Stability and 3D Motion Study of an Experimental Prosthetic Foot
A Phase 3 study testing Experimental prosthetics foot (K3 Promoter) in people with Amputation, run by Tensegrity Prosthetics at 1 site in United States.
Trial summary
The investigators are currently verifying early data showing that the K3 Promoter prosthetic foot affects walking efficiency or stability in transtibial, unilateral amputees when compared to their current prostheses. Phase II funds are being used to address these metrics. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Amputation
- What is being tested?
- Experimental prosthetics foot (K3 Promoter)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Aug 2010
- Phase
- Phase 3
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- K2 or K3 classification based on current prosthetic device.
- Males and females ≥ 18 years of age
- Willing and able to sign informed consent
- Able to read, write, and speak English
- Documented to have a unilateral trans-tibial amputation
- Actively utilizing a definitive prosthesis for at least 12 months
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- Utilizing current prosthetic foot for at least 3 months
- Cognitively functional, in the opinion of their prosthetist
- Able to walk on their existing limb
- Have a healthy residual limb in good condition
- Have a socket with a good, trouble-free fit on their residual limb
Who cannot join
- Significant ulcers or infections associated with a compromised circulation of the other lower limb
- Intermittent Claudication or Critical Leg Ischemia in the non-amputated leg
- K0, K1or K4 Classification
- Irreducible, pronounced knee or hip flexion contractures
- Bilateral amputations
- Use of a walker for ambulation
Show all 11Show fewer
- Severe arthritis that would limit the ability to stand without pain or discomfort or the subject's ability to ambulate is limited by symptoms other than the prothesis (e.g., shortness of breath, fatigue, angina, arthritis, etc.). If, in the opinion of the investigator, the subject were to improve their ability to ambulate from the K3 Promoter to the extent that his or her walking would then be limited by a symptom other than the prothesis, the subject will not be enrolled
- Any other clinically significant medical or psychiatric condition that in the opinion of the Investigator could impact the subject's ability to successfully complete this trial
- Advanced neurologic disorder
- Severe congestive heart failure, angina pectoris, or obstructive pulmonary disease
- Use of medication that causes impaired balance or judgment
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Gait and Movement Analysis
Arvada, Colorado, 80045
James Carollo, PhD, P.E., Carollo.James@tchden.org
About this study
Official title: Stability & 3D Motion Study of an Experimental Prosthetic Foot
The investigators are currently verifying early data showing that the K3 Promoter prosthetic foot affects walking efficiency or stability in transtibial, unilateral amputees when compared to their current prostheses. Phase II funds are being used to address these metrics. These studies are important basic research, however, while Tensegrity has the unique opportunity to study amputee gait and movement in the CGMA's state-of-the-art facility the investigators will expand these studies with BRDG-SPAN funding by studying the following metrics:
- Four Square Step Test (FSST)
- Amputee Mobility Predictor (AMP)
- Timed Up and Go Test (TUG)
- Quality of life (QOL) index (SF-36)
- Activity-specific Balance Confidence Questionnaire (ABC)
- 3D motion analysis
Read the detailed description
The tests will be unblinded randomized studies of the subject's current prosthetic foot and the K3 Promoter on traumatic/congenital amputees and dysvascular/diabetic amputees. Assessments will be made after a 30-day accommodation period with each foot prosthesis. In order to randomize the treatment and factor out habituation to the testing site and the protocol, two cohorts will be used. Half of the volunteers will be randomly assigned to be fitted with the K3 Promoter by their regular prosthetist or will continue wearing their current foot prothesis. Both cohorts will have a 30-day accommodation period. Subjects in either cohort will then visit the CGMA to be tested. Volunteers will then use the other prosthesis for 30 days. After that second 30-day period, height and weight will again be recorded, and the tests will be repeated. Because of anticipated difficulty with scheduling, volunteers will be given a +3 day grace period on the 30 day-accommodation time.
- Conditions
- Amputation
- Being tested
- Experimental prosthetics foot (K3 Promoter)
- Keywords
- K3 Promoter prosthetic foot Tensegrity Prosthetics Jerome Rifkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental prosthetics foot (K3 Promoter)Device
The tests will be unblinded randomized studies of the subject's current prosthetic foot and the K3 Promoter on traumatic/congenital amputees and dysvascular/diabetic amputees. Assessments will be made after a 30-day accommodation period with each foot prosthesis. In order to randomize the treatment and factor out habituation to the testing site and the protocol, two cohorts will be used. Half of the volunteers will be randomly assigned to be fitted with the K3 Promoter by their regular prosthetist or will continue wearing their current foot prothesis. Both cohorts will have a 30-day accommodation period. Subjects in either cohort will then visit the CGMA to be tested. Volunteers will then use the other prosthesis for 30 days. After that second 30-day period, height and weight will again be recorded, and the tests will be repeated. Because of anticipated difficulty with scheduling, volunteers will be given a +3 day grace period on the 30 day-accommodation time.
| Study group | Role | What they receive |
|---|---|---|
| Congenital/Traumatic | Experimental | Individuals who were born with a limb deficiency or who have had a traumatic amputation. Receives: Device: Experimental prosthetics foot (K3 Promoter) |
| Dysvascular/Diabetic | Experimental | Individuals who have had an amputation as a result of vascular disease. Receives: Device: Experimental prosthetics foot (K3 Promoter) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Four Square Step Test
Measured: 2 collections 30 days apart
Amputee Mobility Predictor
Measured: 2 collections 30 days apart
Timed Up and Go Test
Measured: 2 collections 30 days apart
Quality of Life Index
Measured: 2 collections 30 days apart
Activity-specific Balance Confidence Questionnaire
Measured: 2 collections 30 days apart
3D Motion Analysis
Measured: 2 collections 30 days apart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2009 (estimated)
- Study startMay 2010
- Primary completionAug 2010 (estimated)
- Study completionAug 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tensegrity Prosthetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jerome Rifkin, MS, Principal investigator, Tensegrity Prosthetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00968292
- Sponsor's protocol ID
- Rifkin-2
- Status last verified
- Aug 2009
- First submitted
- 26 Aug 2009
- Last updated
- 28 Aug 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stability & 3D Motion Study of an Experimental Prosthetic Foot
- ClinicalTrials.gov ID
- NCT00968292
- Acronym / sponsor ID
- Rifkin-2
- Conditions
- Amputation
- Keywords
- K3 Promoter prosthetic foot Tensegrity Prosthetics Jerome Rifkin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tensegrity ProstheticsIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Aug 2010 (estimated)
- Study completion
- Aug 2010 (estimated)
- First posted
- 28 Aug 2009 (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.
The investigators are currently verifying early data showing that the K3 Promoter prosthetic foot affects walking efficiency or stability in transtibial, unilateral amputees when compared to their current prostheses. Phase II funds are being used to address these metrics. These studies are important basic research, however, while Tensegrity has the unique opportunity to study amputee gait and movement in the CGMA's state-of-the-art facility the investigators will expand these studies with BRDG-SPAN funding by studying the following metrics:
- Four Square Step Test (FSST)
- Amputee Mobility Predictor (AMP)
- Timed Up and Go Test (TUG)
- Quality of life (QOL) index (SF-36)
- Activity-specific Balance Confidence Questionnaire (ABC)
- 3D motion analysis
Detailed description
The tests will be unblinded randomized studies of the subject's current prosthetic foot and the K3 Promoter on traumatic/congenital amputees and dysvascular/diabetic amputees. Assessments will be made after a 30-day accommodation period with each foot prosthesis. In order to randomize the treatment and factor out habituation to the testing site and the protocol, two cohorts will be used. Half of the volunteers will be randomly assigned to be fitted with the K3 Promoter by their regular prosthetist or will continue wearing their current foot prothesis. Both cohorts will have a 30-day accommodation period. Subjects in either cohort will then visit the CGMA to be tested. Volunteers will then use the other prosthesis for 30 days. After that second 30-day period, height and weight will again be recorded, and the tests will be repeated. Because of anticipated difficulty with scheduling, volunteers will be given a +3 day grace period on the 30 day-accommodation time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Congenital/Traumatic | Experimental | Device: Experimental prosthetics foot (K3 Promoter)Individuals who were born with a limb deficiency or who have had a traumatic amputation. |
| Dysvascular/Diabetic | Experimental | Device: Experimental prosthetics foot (K3 Promoter)Individuals who have had an amputation as a result of vascular disease. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- K2 or K3 classification based on current prosthetic device.
- Males and females ≥ 18 years of age
- Willing and able to sign informed consent
- Able to read, write, and speak English
- Documented to have a unilateral trans-tibial amputation
Key exclusion criteria (11 listed)
- Significant ulcers or infections associated with a compromised circulation of the other lower limb
- Intermittent Claudication or Critical Leg Ischemia in the non-amputated leg
- K0, K1or K4 Classification
- Irreducible, pronounced knee or hip flexion contractures
- Bilateral amputations
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 |
|---|---|---|
| Experimental prosthetics foot (K3 Promoter)The tests will be unblinded randomized studies of the subject's current prosthetic foot and the K3 Promoter on traumatic/congenital amputees and dysvascular/diabetic amputees. Assessments will be made after a 30-day accommodation period with each foot prosthesis. In order to randomize the treatment and factor out habituation to the testing site and the protocol, two cohorts will be used. Half of the volunteers will be randomly assigned to be fitted with the K3 Promoter by their regular prosthetist or will continue wearing their current foot prothesis. Both cohorts will have a 30-day accommodation period. Subjects in either cohort will then visit the CGMA to be tested. Volunteers will then use the other prosthesis for 30 days. After that second 30-day period, height and weight will again be recorded, and the tests will be repeated. Because of anticipated difficulty with scheduling, volunteers will be given a +3 day grace period on the 30 day-accommodation time. | Device | Congenital/Traumatic, Dysvascular/Diabetic |
Primary outcome
Four Square Step Test
Time frame: 2 collections 30 days apart
Amputee Mobility Predictor
Time frame: 2 collections 30 days apart
Timed Up and Go Test
Time frame: 2 collections 30 days apart
Quality of Life Index
Time frame: 2 collections 30 days apart
Activity-specific Balance Confidence Questionnaire
Time frame: 2 collections 30 days apart
3D Motion Analysis
Time frame: 2 collections 30 days apart
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2009.
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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.
Jerome Rifkin, MS principal investigator
Tensegrity Prosthetics
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 Experimental prosthetics foot (K3 Promoter) in people with Amputation, run by Tensegrity Prosthetics 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 11 inclusion and 11 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 28 Aug 2009. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jerome Rifkin, MS (303 666 7722, jrifkin@tenspro.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Four Square Step Test (time frame: 2 collections 30 days apart). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2009.