Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Electrical Stimulation for Recovery of Hand Function in Chronic Stroke Survivors

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: NCT00891319
Recruitment Status : Completed
First Posted : May 1, 2009
Results First Posted : November 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
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

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
Enrollment 80
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CCFES cNMES
Hide Arm/Group Description

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 - 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.
Period Title: Overall Study
Started 40 40
Completed 32 40
Not Completed 8 0
Arm/Group Title CCFES cNMES Total
Hide Arm/Group Description

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 - 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 of all reporting groups
Overall Number of Baseline Participants 40 40 80
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 40 participants 40 participants 80 participants
55.4
(48.1 to 66.2)
56.3
(51.9 to 65.2)
56.2
(51.0 to 65.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
Female
14
  35.0%
15
  37.5%
29
  36.3%
Male
26
  65.0%
25
  62.5%
51
  63.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 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  
Median (Inter-Quartile Range)
Unit of measure:  Years since stroke
Number Analyzed 40 participants 40 participants 80 participants
1.8
(0.8 to 3.5)
1.6
(1.0 to 6.0)
1.6
(0.9 to 4.0)
1.Primary Outcome
Title Change in Box and Block Test Score at 6 Mo Post-Treatment
Hide Description

The Box and Blocks test counts how many times the participant can pick up 1 block at t time, move it over a partition, and release it in a target area within 60 seconds.

The minimum score is 0. There is no maximum score. The average score of healthy individuals within the age range of this study ranges from 70 to 79.

Higher scores are considered to be a better outcome. For each individual, the score prior to treatment was subtracted from the score at 6 months after completion of treatment. Then for each treatment group, these change scores were averaged.

Time Frame 2 timepoints: Prior to treatment, and 6 months after completion of treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CCFES cNMES
Hide Arm/Group Description:

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 - 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 10 sessions per week at home.
Overall Number of Participants Analyzed 32 40
Mean (95% Confidence Interval)
Unit of Measure: blocks
4.6
(2.2 to 7.0)
1.8
(0.6 to 3.0)
2.Secondary Outcome
Title Change in Arm Motor Abilities Test Score at 6-Month Post-Treatment
Hide Description

The Arm Motor Abilities Test assesses the participant’s ability to execute specific upper limb tasks and does not allow for compensation with the unimpaired side. The test consists of 9 compound tasks composed of 1 to 3 component tasks, each of which is rated on a 0 – 5 ordinal scale: 0, no attempt to use affected limb; 1, attempt to use affected limb but it does not participate functionally; 2, affected limb is used only as a helper or stabilizer; 3, affected limb is used slowly or within synergy patterns; 4, almost normal use of affected limb; 5, normal use. The final score is the average of all component task scores across all 9 compound tasks.

The minimum score is 0; maximum score is 5. Higher scores are considered to be a better outcome. For each individual, the score prior to treatment was subtracted from the score at 6 months after completion of treatment. Then for each treatment group, these change scores were averaged.

Time Frame 2 timepoints: Prior to treatment, and 6 months after completion of treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CCFES cNMES
Hide Arm/Group Description:

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 - 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 10 sessions per week at home.
Overall Number of Participants Analyzed 32 40
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0.18
(0.06 to 0.31)
0.04
(-0.07 to 0.15)
3.Secondary Outcome
Title Change in Upper Extremity Fugl-Meyer Score at 6-Months Post-Treatment
Hide Description

The Upper Extremity Fugl-Meyer (UEFM) Assessment is a measure of upper limb motor impairment. Participants are asked to attempt to perform a list of very specific movements of the arm, elbow, forearm, wrist, and hand that take into account synergy patterns, isolated strength, coordination, and hypertonia. Each movement attempt is graded on a 3-point ordinal scale (0, cannot perform; 1, perform partially; and 2, perform fully) and these subscores are summed to provide a maximum score of 66, minimum score of 0.

Higher scores are considered to be a better outcome. For each individual, the score prior to treatment was subtracted from the score at 6 months after completion of treatment. Then for each treatment group, these change scores were averaged.

Time Frame 2 timepoints: Prior to treatment, and 6 months after completion of treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CCFES cNMES
Hide Arm/Group Description:

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 - 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 10 sessions per week at home.
Overall Number of Participants Analyzed 32 40
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
2.4
(0.5 to 4.3)
2.2
(0.7 to 3.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CCFES cNMES
Hide Arm/Group Description

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 - 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 10 sessions per week at home.
All-Cause Mortality
CCFES cNMES
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
CCFES cNMES
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/40 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CCFES cNMES
Affected / at Risk (%) Affected / at Risk (%)
Total   4/40 (10.00%)   1/40 (2.50%) 
General disorders     
Headaches after therapy sessions *  1/40 (2.50%)  0/40 (0.00%) 
Nervous system disorders     
Stimulation uncomfortable *  1/40 (2.50%)  0/40 (0.00%) 
Skin and subcutaneous tissue disorders     
Skin irritation from electrodes *  2/40 (5.00%)  1/40 (2.50%) 
*
Indicates events were collected by non-systematic assessment
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
Responsible Party: Jayme Knutson, MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT00891319     History of Changes
Other Study ID Numbers: R01HD059814 ( U.S. NIH Grant/Contract )
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