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
Sponsor:
Information provided by:
Tensegrity Prosthetics
ClinicalTrials.gov Identifier:
NCT00968292
First received: August 26, 2009
Last updated: August 27, 2009
Last verified: August 2009
  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:

  1. Four Square Step Test (FSST)
  2. Amputee Mobility Predictor (AMP)
  3. Timed Up and Go Test (TUG)
  4. Quality of life (QOL) index (SF-36)
  5. Activity-specific Balance Confidence Questionnaire (ABC)
  6. 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:

  1. K2 or K3 classification based on current prosthetic device.
  2. Males and females ≥ 18 years of age
  3. Willing and able to sign informed consent
  4. Able to read, write, and speak English
  5. Documented to have a unilateral trans-tibial amputation
  6. Actively utilizing a definitive prosthesis for at least 12 months
  7. Utilizing current prosthetic foot for at least 3 months
  8. Cognitively functional, in the opinion of their prosthetist
  9. Able to walk on their existing limb
  10. Have a healthy residual limb in good condition
  11. Have a socket with a good, trouble-free fit on their residual limb

Exclusion Criteria:

  1. Significant ulcers or infections associated with a compromised circulation of the other lower limb
  2. Intermittent Claudication or Critical Leg Ischemia in the non-amputated leg
  3. K0, K1or K4 Classification
  4. Irreducible, pronounced knee or hip flexion contractures
  5. Bilateral amputations
  6. Use of a walker for ambulation
  7. 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
  8. 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
  9. Advanced neurologic disorder
  10. Severe congestive heart failure, angina pectoris, or obstructive pulmonary disease
  11. Use of medication that causes impaired balance or judgment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014