Trial Outcomes & Findings for Electrical Stimulation for Recovery of Hand Function in Chronic Stroke Survivors (NCT NCT00891319)
NCT ID: NCT00891319
Last Updated: 2017-11-06
Results Overview
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.
COMPLETED
NA
80 participants
2 timepoints: Prior to treatment, and 6 months after completion of treatment.
2017-11-06
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
32
|
40
|
|
Overall Study
NOT COMPLETED
|
8
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Electrical Stimulation for Recovery of Hand Function in Chronic Stroke Survivors
Baseline characteristics by cohort
| Measure |
CCFES
n=40 Participants
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
n=40 Participants
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
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.4 years
n=93 Participants
|
56.3 years
n=4 Participants
|
56.2 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
51 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
41 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Years Since Stroke
|
1.8 years since stroke
n=93 Participants
|
1.6 years since stroke
n=4 Participants
|
1.6 years since stroke
n=27 Participants
|
PRIMARY outcome
Timeframe: 2 timepoints: Prior to treatment, and 6 months after completion of treatment.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.
Outcome measures
| Measure |
CCFES
n=32 Participants
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
n=40 Participants
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.
|
|---|---|---|
|
Change in Box and Block Test Score at 6 Mo Post-Treatment
|
4.6 blocks
Interval 2.2 to 7.0
|
1.8 blocks
Interval 0.6 to 3.0
|
SECONDARY outcome
Timeframe: 2 timepoints: Prior to treatment, and 6 months after completion of treatment.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.
Outcome measures
| Measure |
CCFES
n=32 Participants
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
n=40 Participants
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.
|
|---|---|---|
|
Change in Arm Motor Abilities Test Score at 6-Month Post-Treatment
|
0.18 units on a scale
Interval 0.06 to 0.31
|
0.04 units on a scale
Interval -0.07 to 0.15
|
SECONDARY outcome
Timeframe: 2 timepoints: Prior to treatment, and 6 months after completion of treatment.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.
Outcome measures
| Measure |
CCFES
n=32 Participants
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
n=40 Participants
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.
|
|---|---|---|
|
Change in Upper Extremity Fugl-Meyer Score at 6-Months Post-Treatment
|
2.4 units on a scale
Interval 0.5 to 4.3
|
2.2 units on a scale
Interval 0.7 to 3.7
|
Adverse Events
CCFES
cNMES
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CCFES
n=40 participants at risk
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
n=40 participants at risk
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.
|
|---|---|---|
|
General disorders
Headaches after therapy sessions
|
2.5%
1/40
|
0.00%
0/40
|
|
Skin and subcutaneous tissue disorders
Skin irritation from electrodes
|
5.0%
2/40
|
2.5%
1/40
|
|
Nervous system disorders
Stimulation uncomfortable
|
2.5%
1/40
|
0.00%
0/40
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place