Enhancing Function Using the RF Microstimulator Gait System Following Stroke 2008

This study has been terminated.
(The enrollment period/study duration had exceeded The Alfred Mann Foundation's timeline.)
Sponsor:
Collaborator:
The Alfred E. Mann Foundation for Scientific Research
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00864708
First received: March 17, 2009
Last updated: May 7, 2014
Last verified: May 2014
Results First Received: November 25, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Stroke
Intervention: Device: radio frequency-controlled (RF) Microstimulator (RFM) Gait System

  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
Dec 2008 – October 2009, recruitment by flier and by word of mouth

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
Arm 1 Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System

Participant Flow:   Overall Study
    Arm 1  
STARTED     1  
COMPLETED     1  
NOT COMPLETED     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.
This was a feasibility study to test an RFM Gait System for re-training gait coordination. Number of participants was limited to sponsor timeline.

Reporting Groups
  Description
Arm 1 Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System )

Baseline Measures
    Arm 1  
Number of Participants  
[units: participants]
  1  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     1  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  37  ± 0  
Gender  
[units: participants]
 
Female     1  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     1  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Walking Endurance (6MWT)   [ Time Frame: Day 1 and at 3 months, following treatment ]

2.  Primary:   Kinematic Gait Measures   [ Time Frame: Day 1 and at 3 months, following treatment ]

3.  Secondary:   Fugl-Meyer Lower Extremity Score   [ Time Frame: Day 1 and at 3 months, following treatment ]

4.  Secondary:   Ashworth Scale   [ Time Frame: Day 1 and at 3 months, following treatment ]

5.  Secondary:   Stroke Impact Scale (SIS)   [ Time Frame: Day 1 and at 3 months, following treatment ]

6.  Secondary:   Manual Muscle Testing (MMT)   [ Time Frame: Day 1 and at 3 months, following treatment ]


  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
Study sponsor, Alfred Mann foundation (AMF) stopped study because “enrollment period/study duration has exceeded the AMF’s timeline”.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Janis Daly, Ph.D., M.S.; Director, Brain Rehabilitation Research Center of Excellence
Organization: NF/SG VA Medical Center, Gainesville Florida
phone: (352) 376-1611 ext 5223
e-mail: janis.daly@neurology.ufl.edu


No publications provided


Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00864708     History of Changes
Other Study ID Numbers: B3252-R, B3513R
Study First Received: March 17, 2009
Results First Received: November 25, 2013
Last Updated: May 7, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration