ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 6 of 51 for:    Foot Drop

Clinical Study of the L300 Versus Ankle-foot Orthosis (AFO) on Post-Stroke Subjects With Foot Drop (L300)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01138995
Recruitment Status : Completed
First Posted : June 8, 2010
Results First Posted : April 28, 2016
Last Update Posted : April 28, 2016
Sponsor:
Collaborators:
Medidata Solutions
University of Cincinnati
Information provided by (Responsible Party):
Bioness Inc

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Sensorimotor Gait Disorder
Neurologic Ambulation Disorder
Gait, Drop Foot
Poststroke Hemiparesis
Post-Cerebrovascular Accident (CVA) Hemiparesis
Interventions: Device: Ness L300
Device: Ankle-foot orthosis

  Participant Flow

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
Originial Control Group

The Control Group will walk with the a "usual" ankle-foot orthosis (AFO)for 30 weeks. After 30 weeks, the Original Control Group will then be crossed over to walk with the Ness L300 for a total of 12 weeks.

Ness L300: The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.

Ness L300: The Original Treatment Group will walk with the Ness L300 for 42 weeks, and the Original Control Group will walk with a "usual" ankle-foot orthosis (AFO)for 30 weeks, then be crossed over to walk with the Ness L300 for a total of 12 weeks.

Original Treatment Group

The Original Treatment Group will walk with the Ness L300 for 42 weeks.

Ness L300: The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.

Ness L300: The Original Treatment Group will walk with the Ness L300 for 42 weeks, and the Original Control Group will walk with a "usual" ankle-foot orthosis (AFO)for 30 weeks, then be crossed over to walk with the Ness L300 for a total of 12 weeks.


Participant Flow:   Overall Study
    Originial Control Group   Original Treatment Group
STARTED   98   99 
COMPLETED   88   74 
NOT COMPLETED   10   25 



  Baseline Characteristics

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
Originial Control Group

The Control Group will walk with the a "usual" ankle-foot orthosis (AFO)for 30 weeks. After 30 weeks, the Original Control Group will then be crossed over to walk with the Ness L300 for a total of 12 weeks.

Ness L300: The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.

Ness L300: The Original Treatment Group will walk with the Ness L300 for 42 weeks, and the Original Control Group will walk with a "usual" ankle-foot orthosis (AFO)for 30 weeks, then be crossed over to walk with the Ness L300 for a total of 12 weeks.

Original Treatment Group

The Original Treatment Group will walk with the Ness L300 for 42 weeks.

Ness L300: The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.

Ness L300: The Original Treatment Group will walk with the Ness L300 for 42 weeks, and the Original Control Group will walk with a "usual" ankle-foot orthosis (AFO)for 30 weeks, then be crossed over to walk with the Ness L300 for a total of 12 weeks.

Total Total of all reporting groups

Baseline Measures
   Originial Control Group   Original Treatment Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 98   99   197 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.6  (10.9)   60.7  (12.2)   61.1  (11.6) 
Gender 
[Units: Participants]
     
Female   31   48   79 
Male   67   51   118 
Region of Enrollment 
[Units: Participants]
     
United States   98   99   197 


  Outcome Measures

1.  Primary:   Ten Meter Walk Test (10mWT)   [ Time Frame: Week 30 ]

2.  Secondary:   Berg Balance Scale (BBS) Score   [ Time Frame: Week 30 ]

3.  Secondary:   User Satisfaction   [ Time Frame: Week 30 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Keith McBride, CTO
Organization: Bioness
phone: 661-362-4866
e-mail: Keith.McBride@bioness.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bioness Inc
ClinicalTrials.gov Identifier: NCT01138995     History of Changes
Other Study ID Numbers: CP-L300-0801, Rev. B
First Submitted: June 4, 2010
First Posted: June 8, 2010
Results First Submitted: February 1, 2016
Results First Posted: April 28, 2016
Last Update Posted: April 28, 2016