Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Measures of Gait Efficiency of Three Multi-Axial, Vertical Shock and Energy Storing-Return Prosthetic Feet During Simple & Complex Mobility Activities

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
William Quillen, University of South Florida
ClinicalTrials.gov Identifier:
NCT01404559
First received: May 31, 2011
Last updated: December 4, 2014
Last verified: December 2014
Results First Received: November 17, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Amputation
Interventions: Device: Ossur Variflex prosthetic foot
Device: Ossur Ceterus prosthetic foot
Device: Endolite Elite Blade prosthetic foot

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Prosthetic Foot 1 (Ossur Variflex)

This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 1 (Ossur Variflex; 1 week) then prosthetic foot 2(Ossur Ceterus; 1 week) then prosthetic foot 3(Endolite Elite Blade;1 week).

Ossur Variflex prosthetic foot: Lightweight energy-storing prosthetic foot

Prosthetic Foot 2 (Ossur Ceterus)

This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 2(Ossur Ceterus; 1 week) then prosthetic foot 1 (Ossur Variflex; 1 week) then prosthetic foot 3(Endolite Elite Blade; 1 week).

Ossur Ceterus prosthetic foot: Shock-absorbing prosthetic foot

Prosthetic Foot 3 (Endolite Elite Blade)

This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 3(Endolite Elite Blade; 1 week) the prosthetic foot 1(Ossur Variflex; 1 week) then prosthetic foot 2(Ossur Ceterus; 1 week).

Endolite Elite Blade prosthetic foot: Multi-axial prosthetic foot

Non-amputee Controls

This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.

No intervention. Control group.: There are no interventions in this observational arm of the study.


Participant Flow:   Overall Study
    Prosthetic Foot 1 (Ossur Variflex)     Prosthetic Foot 2 (Ossur Ceterus)     Prosthetic Foot 3 (Endolite Elite Blade)     Non-amputee Controls  
STARTED     5     5     4     14  
COMPLETED     5     5     4     14  
NOT COMPLETED     0     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Transtibial Amputees This arm included unilateral transtibial amputees who who were crossed over into 3 different prosthetic feet and assessed per intervention.
Non-amputee Controls

This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.

No intervention. Control group.: There are no interventions in this observational arm of the study.

Total Total of all reporting groups

Baseline Measures
    Transtibial Amputees     Non-amputee Controls     Total  
Number of Participants  
[units: participants]
  14     14     28  
Age  
[units: years]
Mean ± Standard Deviation
  31.4  ± 5.9     38.5  ± 5.1     33.2  ± 5.7  
Gender  
[units: participants]
     
Female     0     0     0  
Male     14     14     28  
Region of Enrollment  
[units: participants]
     
United States     14     14     28  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Obstacle Course Completion Time   [ Time Frame: 21 days total (7days per prosthetic foot condition) ]

2.  Primary:   Bioenergetics Between Feet Components 21 Days After Fitting Prostheses   [ Time Frame: 21 days total (7days per prosthetic foot condition) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: William S. Quillen
Organization: University of South Florida
phone: 8139749863
e-mail: wquillen@health.usf.edu


No publications provided


Responsible Party: William Quillen, University of South Florida
ClinicalTrials.gov Identifier: NCT01404559     History of Changes
Other Study ID Numbers: 10193006
Study First Received: May 31, 2011
Results First Received: November 17, 2014
Last Updated: December 4, 2014
Health Authority: United States: Institutional Review Board