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Electrical Stimulation for Recovery of Hand Function in Chronic Stroke Survivors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00891319
First Posted: May 1, 2009
Last Update Posted: November 6, 2017
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.
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Case Western Reserve University
Information provided by (Responsible Party):
Jayme Knutson, MetroHealth Medical Center
Results First Submitted: September 8, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Stroke
Hemiparesis
Hemiplegia
Intervention: Device: Electrical stimulator

  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
CCFES

CCFES - Contralaterally Controlled Functional Electrical Stimulation

*Stimulation to paretic finger and thumb extensors only in response to, and with an intensity proportional to, opening of the contralateral unimpaired hand. A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and controls stimulation intensity delivered to the affected hand.

12-week intervention

  1. Lab: Therapist-guided CCFES-assisted task practice performed twice a week in the research laboratory.
  2. Home: Self-administered CCFES-mediated hand opening exercise performed 10 sessions per week at home.
cNMES

cNMES - Cyclic NeuroMuscular Electrical Stimulation

*Preprogrammed cycles of finger and thumb extensor stimulation repeatedly and automatically open the paretic hand.

12-week intervention

  1. Lab: Therapist-guided task practice performed twice a week in the research laboratory.
  2. Home: Self-administered cNMES-mediated hand opening exercise performed t10 sessions per week at home.

Participant Flow:   Overall Study
    CCFES   cNMES
STARTED   40   40 
COMPLETED   32   40 
NOT COMPLETED   8   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.
No text entered.

Reporting Groups
  Description
CCFES

CCFES - Contralaterally Controlled Functional Electrical Stimulation

*Stimulation to paretic finger and thumb extensors only in response to, and with an intensity proportional to, opening of the contralateral unimpaired hand. A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and controls stimulation intensity delivered to the affected hand.

12-week intervention

  1. Lab: Therapist-guided CCFES-assisted task practice performed twice a week in the research laboratory.
  2. Home: Self-administered CCFES-mediated hand opening exercise performed 10 sessions per week at home.
cNMES

cNMES - Cyclic NeuroMuscular Electrical Stimulation

*Preprogrammed cycles of finger and thumb extensor stimulation repeatedly and automatically open the paretic hand.

12-week intervention

  1. Lab: Therapist-guided task practice performed twice a week in the research laboratory.
  2. Home: Self-administered cNMES-mediated hand opening exercise performed t10 sessions per week at home.
Total Total of all reporting groups

Baseline Measures
   CCFES   cNMES   Total 
Overall Participants Analyzed 
[Units: Participants]
 40   40   80 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 55.4 
 (48.1 to 66.2) 
 56.3 
 (51.9 to 65.2) 
 56.2 
 (51.0 to 65.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      14  35.0%      15  37.5%      29  36.3% 
Male      26  65.0%      25  62.5%      51  63.7% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      22  55.0%      17  42.5%      39  48.8% 
White      18  45.0%      23  57.5%      41  51.2% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Years Since Stroke 
[Units: Years since stroke]
Median (Inter-Quartile Range)
 1.8 
 (0.8 to 3.5) 
 1.6 
 (1.0 to 6.0) 
 1.6 
 (0.9 to 4.0) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Box and Block Test Score at 6 Mo Post-Treatment   [ Time Frame: 2 timepoints: Prior to treatment, and 6 months after completion of treatment. ]

2.  Secondary:   Change in Arm Motor Abilities Test Score at 6-Month Post-Treatment   [ Time Frame: 2 timepoints: Prior to treatment, and 6 months after completion of treatment. ]

3.  Secondary:   Change in Upper Extremity Fugl-Meyer Score at 6-Months Post-Treatment   [ Time Frame: 2 timepoints: Prior to treatment, and 6 months after completion of 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
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  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. Jayme Knutson
Organization: MetroHealth Medical Center
phone: 2169573557 ext 216
e-mail: jsk12@case.edu


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

Responsible Party: Jayme Knutson, MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT00891319     History of Changes
Other Study ID Numbers: R01HD059814 ( U.S. NIH Grant/Contract )
First Submitted: September 25, 2008
First Posted: May 1, 2009
Results First Submitted: September 8, 2017
Results First Posted: November 6, 2017
Last Update Posted: November 6, 2017