Treatment of Hand Dysfunction After Stroke

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. Identifier: NCT00508521
Recruitment Status : Completed
First Posted : July 30, 2007
Results First Posted : February 7, 2014
Last Update Posted : February 7, 2014
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Stroke
Interventions: Device: Functional Electrical Stimulation
Other: Standard Care

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited through the use of study 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
All subjects enrolled in the study were entered into the same arm of this pilot study

Reporting Groups
FES and Motor Learning Training Group Subjects < 6 months following first stroke who had diminished upper limb strength, coordination and function.

Participant Flow:   Overall Study
    FES and Motor Learning Training Group

  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
Arm 1 Subjects With Acute Stroke Subjects < 6 months following first stroke who had diminished upper limb strength, coordination and function.

Baseline Measures
   Arm 1 Subjects With Acute Stroke 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   4 
>=65 years   0 
[Units: Participants]
Female   2 
Male   2 
Region of Enrollment 
[Units: Participants]
United States   4 

  Outcome Measures

1.  Primary:   Fugl-Meyer Upper Limb Coordination Scale (FMUE)   [ Time Frame: baseline and after 12 weeks of training ]

  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
This was a small pilot feasibility study providing data for future work.

  More Information

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

Results Point of Contact:  
Name/Title: Janis Daly, Ph.D., M.S.; Director, Brain Rehabilitation Research Center
Organization: Malcom Randall VA Medical Center, Gainesville Florida
phone: (352) 376-1611 ext 6603

Responsible Party: VA Office of Research and Development Identifier: NCT00508521     History of Changes
Other Study ID Numbers: B4078-R
First Submitted: July 27, 2007
First Posted: July 30, 2007
Results First Submitted: October 30, 2013
Results First Posted: February 7, 2014
Last Update Posted: February 7, 2014