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Efficacy of Functional Electrical Stimulation (FES) in Persons Receiving Botulinum Neurotoxin for Upper Extremity Spasticity (Botox + FES)

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ClinicalTrials.gov Identifier: NCT00462449
Recruitment Status : Completed
First Posted : April 19, 2007
Results First Posted : June 20, 2014
Last Update Posted : June 20, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Upper Extremity Spasticity
Stroke
Acquired Brain Injury
Intervention: Device: Functional Electrical Stimulation (FES) through the Ness H200

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period from 11/15/2007 through 10/05/2009. Subjects were recruited primarily from the PI's clinical patient pool with unilateral, upper extremity spasticity. All subjects were required to be at least 6 months post insult.

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
Chedoke-McMaster Assessment Hand Impairment 2, 3 - RTP Alone Individuals randomized into this group will only receive specialized therapy associated with this population.
Chedoke-McMaster Assessment Hand Impairment 4-6 RTP + FES In addition to appropriate therapy, this group will receive the FES device and be given instruction on how to complete specialized exercises utilizing this device.

Participant Flow:   Overall Study
    Chedoke-McMaster Assessment Hand Impairment 2, 3 - RTP Alone   Chedoke-McMaster Assessment Hand Impairment 4-6 RTP + FES
STARTED   13   10 
COMPLETED   13   10 
NOT COMPLETED   0   0 



  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
Chedoke-McMaster Assessment Hand Impairment 2, 3 - RTP Alone Individuals randomized into this group will only receive specialized therapy associated with this population.
Chedoke-McMaster Assessment Hand Impairment 4-6 RTP + FES In addition to appropriate therapy, this group will receive the FES device and be given instruction on how to complete specialized exercises utilizing this device.
Total Total of all reporting groups

Baseline Measures
   Chedoke-McMaster Assessment Hand Impairment 2, 3 - RTP Alone   Chedoke-McMaster Assessment Hand Impairment 4-6 RTP + FES   Total 
Overall Participants Analyzed 
[Units: Participants]
 13   10   23 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   12   9   21 
>=65 years   1   1   2 
Age 
[Units: Years]
Mean (Standard Deviation)
 41.2  (14.2)   54  (10.3)   47.4  (14.0) 
Gender 
[Units: Participants]
     
Female   9   6   15 
Male   4   4   8 
Region of Enrollment 
[Units: Participants]
     
United States   13   10   23 


  Outcome Measures

1.  Primary:   Change From Baseline in Arm Function Based on Motor Activities Log (MAL-O)   [ Time Frame: 12 weeks ]

2.  Secondary:   Change From Baseline in Dexterous Hand Function as Measured by the Action Research Arm Test (ARAT)   [ Time Frame: 12 weeks ]

3.  Secondary:   Change From Baseline in Self-performance in Activities of Daily Living Assessed With the (MAL - Self Report)   [ Time Frame: 12 weeks ]


  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 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: Dr. Michael C. Munin
Organization: Department of Physical Medicine and Rehabilitation University of Pittsburgh
phone: 412-648-6848
e-mail: muninm@upmc.edu


Publications:
Rose DK, Winstein CJ, Tan SM, Azen SP, Chui HC. (2001). Comparison of upper extremity intervention strategies at six and nine months post-stroke. Neurol Rep 25: 130.
Winstein CJ, Rose DK, Chui HC et al. (2001) Recovery and rehabilitation of arm use after stroke. J Stroke Cerebrovasc Dis 10: 197.


Responsible Party: Michael C. Munin, M.D., University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00462449     History of Changes
Other Study ID Numbers: 0611012
First Submitted: April 17, 2007
First Posted: April 19, 2007
Results First Submitted: August 11, 2011
Results First Posted: June 20, 2014
Last Update Posted: June 20, 2014