Stability and 3D Motion Study of an Experimental Prosthetic Foot
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Tensegrity Prosthetics.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Tensegrity Prosthetics
Information provided by:
Tensegrity Prosthetics
ClinicalTrials.gov Identifier:
NCT00968292
First received: August 26, 2009
Last updated: August 27, 2009
Last verified: August 2009
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Amputation |
Device: Experimental prosthetics foot (K3 Promoter) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Stability & 3D Motion Study of an Experimental Prosthetic Foot |
Resource links provided by NLM:
Further study details as provided by Tensegrity Prosthetics:
Primary Outcome Measures:
- Four Square Step Test [ Time Frame: 2 collections 30 days apart ] [ Designated as safety issue: No ]
- Amputee Mobility Predictor [ Time Frame: 2 collections 30 days apart ] [ Designated as safety issue: No ]
- Timed Up and Go Test [ Time Frame: 2 collections 30 days apart ] [ Designated as safety issue: No ]
- Quality of Life Index [ Time Frame: 2 collections 30 days apart ] [ Designated as safety issue: No ]
- Activity-specific Balance Confidence Questionnaire [ Time Frame: 2 collections 30 days apart ] [ Designated as safety issue: No ]
- 3D Motion Analysis [ Time Frame: 2 collections 30 days apart ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | August 2010 |
| Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Congenital/Traumatic
Individuals who were born with a limb deficiency or who have had a traumatic amputation.
|
Device: 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.
|
|
Experimental: Dysvascular/Diabetic
Individuals who have had an amputation as a result of vascular disease.
|
Device: 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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00968292
Contacts
| Contact: Jerome Rifkin, MS | 303 666 7722 | jrifkin@tenspro.com |
Locations
| United States, Colorado | |
| Center for Gait and Movement Analysis | Not yet recruiting |
| Arvada, Colorado, United States, 80045 | |
| Contact: James Carollo, PhD, P.E. Carollo.James@tchden.org | |
Sponsors and Collaborators
Tensegrity Prosthetics
Investigators
| Principal Investigator: | Jerome Rifkin, MS | Tensegrity Prosthetics |
More Information
Additional Information:
No publications provided
| Responsible Party: | Jerome Rifkin CEO/CTO, Tensegrity Prosthetics |
| ClinicalTrials.gov Identifier: | NCT00968292 History of Changes |
| Other Study ID Numbers: | Rifkin-2 |
| Study First Received: | August 26, 2009 |
| Last Updated: | August 27, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Tensegrity Prosthetics:
|
K3 Promoter prosthetic foot Tensegrity Prosthetics Jerome Rifkin |
ClinicalTrials.gov processed this record on May 19, 2013