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Functional Electrical Stimulation (FES) Driven Stepping in Individuals With Spinal Cord Injury

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cristina Sadowsky, M.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
ClinicalTrials.gov Identifier:
NCT01479777
First received: November 15, 2011
Last updated: September 9, 2014
Last verified: September 2014
Results First Received: August 1, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Spinal Cord Injury
Intervention: Device: FES Stepping (RT600 from Restorative Therapies, INC.)

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
FES Stepping For the next 8 weeks, we will ask you to come to the ICSCI twice (2) time per week during which you will perform FES Stepping.

Participant Flow:   Overall Study
    FES Stepping  
STARTED     12  
COMPLETED     10  
NOT COMPLETED     2  
Physician Decision                 2  



  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.
No text entered.

Reporting Groups
  Description
FES Stepping FES Stepping, twice a week, for 8 weeks.

Baseline Measures
    FES Stepping  
Number of Participants  
[units: participants]
  12  
Age  
[units: years]
Mean ± Standard Deviation
  37  ± 15  
Gender  
[units: participants]
 
Female     5  
Male     7  



  Outcome Measures
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1.  Primary:   Change in Motor and Sensory Scores of the ASIA Impairment Scale (AIS)   [ Time Frame: Baseline, 8 weeks ]

2.  Secondary:   Change in Heart Rate   [ Time Frame: Baseline, 8 weeks ]

3.  Secondary:   Change in Systolic Blood Pressure   [ Time Frame: Baseline, 8 weeks ]

4.  Secondary:   Change in Diastolic Plood Pressure   [ Time Frame: Baseline, 8 weeks ]

5.  Secondary:   Change in Rate of Perceived Exertion   [ Time Frame: Baseline, 8 weeks ]

6.  Secondary:   Change in Vital Capacity   [ Time Frame: Baseline, 8 weeks ]

7.  Secondary:   Change in Peak Cough Flow   [ Time Frame: Baseline, 8 weeks ]


  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
None


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Cristina Sadowsky
Organization: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
phone: 443-923-9210
e-mail: sadowsky@kennedykrieger.org


No publications provided


Responsible Party: Cristina Sadowsky, M.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
ClinicalTrials.gov Identifier: NCT01479777     History of Changes
Other Study ID Numbers: NA_00016421
Study First Received: November 15, 2011
Results First Received: August 1, 2013
Last Updated: September 9, 2014
Health Authority: United States: Institutional Review Board