Trial Outcomes & Findings for Treatments for Recovery of Hand Function in Acute Stroke Survivors (NCT NCT00565045)
NCT ID: NCT00565045
Last Updated: 2018-12-19
Results Overview
A custom-built electrogoniometer recorded the angles of the metacarpophalangeal (MP) and proximal interphalangeal (PIP) joints of the index finger simultaneously. Participants were seated with the forearm and wrist supported and stabilized in a neutral posture. From this resting postion, they were instructed to extend their fingers as fully as possible in response to a 4-sec audio cue. The MP and PIP angles were added together, providing a composite measure of degree of finger extension, where 0 degrees corresponds to full extension of the MP and PIP joints. The more negative the angle, the more flexed the finger.
COMPLETED
PHASE1/PHASE2
21 participants
3 months post-treatment.
2018-12-19
Participant Flow
Participant milestones
| Measure |
CCFES
CCFES - Contralaterally Controlled Functional Electrical Stimulation
* Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing of the contralateral unimpaired hand
* A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity
* Therapy sessions are done with the subject being assisted by the CCFES system.
|
cNMES
cNMES - Cyclic NeuroMuscular Electrical Stimulation.
* Preprogrammed cycles of finger and thumb flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.
* Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation
* Therapy sessions are done without the stimulation system
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
|
Overall Study
COMPLETED
|
9
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatments for Recovery of Hand Function in Acute Stroke Survivors
Baseline characteristics by cohort
| Measure |
CCFES
n=10 Participants
CCFES - Contralaterally Controlled Functional Electrical Stimulation
* Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing of the contralateral unimpaired hand
* A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity
* Therapy sessions are done with the subject being assisted by the CCFES system.
|
cNMES
n=11 Participants
cNMES - Cyclic NeuroMuscular Electrical Stimulation.
* Preprogrammed cycles of finger and thumb flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.
* Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation
* Therapy sessions are done without the stimulation system
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
53.8 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
43.9 years
STANDARD_DEVIATION 15.2 • n=7 Participants
|
48.6 years
STANDARD_DEVIATION 14.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
11 participants
n=7 Participants
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 months post-treatment.Population: The participants who completed the 6-week treatment phase were included in the analysis.
A custom-built electrogoniometer recorded the angles of the metacarpophalangeal (MP) and proximal interphalangeal (PIP) joints of the index finger simultaneously. Participants were seated with the forearm and wrist supported and stabilized in a neutral posture. From this resting postion, they were instructed to extend their fingers as fully as possible in response to a 4-sec audio cue. The MP and PIP angles were added together, providing a composite measure of degree of finger extension, where 0 degrees corresponds to full extension of the MP and PIP joints. The more negative the angle, the more flexed the finger.
Outcome measures
| Measure |
CCFES
n=9 Participants
CCFES - Contralaterally Controlled Functional Electrical Stimulation
* Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing of the contralateral unimpaired hand
* A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity
* Therapy sessions are done with the subject being assisted by the CCFES system.
|
cNMES
n=8 Participants
cNMES - Cyclic NeuroMuscular Electrical Stimulation.
* Preprogrammed cycles of finger and thumb flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.
* Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation
* Therapy sessions are done without the stimulation system
|
|---|---|---|
|
Maximum Voluntary Finger Extension Angle (a Measure of Hand Impairment)
|
-11.6 degrees
Standard Error 11.7
|
-43.4 degrees
Standard Error 12.5
|
SECONDARY outcome
Timeframe: 3 months post-treatment.Population: The participants who completed the 6-week treatment phase were included in the analysis.
A 30-sec 0.1Hz sine wave track scrolled from right to left on a computer screen in front of the participant. The amplitude of the sine wave was scaled to match the middle 70% of the participant's voluntary finger active range of motion (AROM). A cursor on the computer screen moved up and down as the participant extended and flexed their index finger. The task was to trace the scrolling sine wave with the cursor. Tracking error was the average vertical distance between the cursor and the target trace. Since the track was scaled to the participant's finger AROM, the distance between the cursor and the target trace (and therefore the tracking error) is in units corresponding to the percentage (%) of the participant's finger active range of motion (AROM), hereafter abbreviated %AROM.
Outcome measures
| Measure |
CCFES
n=9 Participants
CCFES - Contralaterally Controlled Functional Electrical Stimulation
* Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing of the contralateral unimpaired hand
* A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity
* Therapy sessions are done with the subject being assisted by the CCFES system.
|
cNMES
n=8 Participants
cNMES - Cyclic NeuroMuscular Electrical Stimulation.
* Preprogrammed cycles of finger and thumb flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.
* Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation
* Therapy sessions are done without the stimulation system
|
|---|---|---|
|
Finger Tracking Error
|
4.7 % AROM
Standard Error 1.9
|
8.3 % AROM
Standard Error 2.0
|
SECONDARY outcome
Timeframe: 3 months post-treatment.Population: The participants who completed the 6-week treatment phase were included in the analysis.
The number of blocks picked up and moved across a barrier in 60 seconds
Outcome measures
| Measure |
CCFES
n=9 Participants
CCFES - Contralaterally Controlled Functional Electrical Stimulation
* Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing of the contralateral unimpaired hand
* A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity
* Therapy sessions are done with the subject being assisted by the CCFES system.
|
cNMES
n=8 Participants
cNMES - Cyclic NeuroMuscular Electrical Stimulation.
* Preprogrammed cycles of finger and thumb flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.
* Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation
* Therapy sessions are done without the stimulation system
|
|---|---|---|
|
Box and Blocks Score
|
29.8 blocks
Standard Error 3.8
|
22.9 blocks
Standard Error 4.1
|
SECONDARY outcome
Timeframe: 3 months post-treatment.Population: The participants who completed the 6-week treatment phase were analyzed.
The Arm Motor Abilities Test (AMAT) score is an average across 9 different compound activities of daily living (ADL) tasks composed of 1 to 3 component tasks, each of which was scored by a therapist using a 0 to 5 ordinal scale: 0, no attempt to use affected limb; 1, attempt to use affected limb but it doesn't participate functionally; 2, affected limb is used only as a helper or stabilizer; 3, affected limb is used slowly or within synergy patterns; 4, affected limb use almost normal; 5, normal use. Each of the 9 tasks is scored and then the average score across the 9 tasks is calculated, with a range of 0 to 5.
Outcome measures
| Measure |
CCFES
n=9 Participants
CCFES - Contralaterally Controlled Functional Electrical Stimulation
* Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing of the contralateral unimpaired hand
* A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity
* Therapy sessions are done with the subject being assisted by the CCFES system.
|
cNMES
n=8 Participants
cNMES - Cyclic NeuroMuscular Electrical Stimulation.
* Preprogrammed cycles of finger and thumb flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.
* Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation
* Therapy sessions are done without the stimulation system
|
|---|---|---|
|
Arm Motor Abilities Test
|
3.54 units on a scale
Standard Error 0.27
|
3.20 units on a scale
Standard Error 0.29
|
SECONDARY outcome
Timeframe: 3 months post-treatment.Population: The participants who completed the 6-week treatment phase were analyzed.
The participant was asked to perform specific coordinated and isolated shoulder, elbow, wrist, and hand movements. Each movement was rated by a therapist using a 3-point ordinal scale: 0, cannot perform; 1, perform partially; 2, perform fully) and summed to produce an overall score, with a range of 0 to 66 (the higher the score the better).
Outcome measures
| Measure |
CCFES
n=9 Participants
CCFES - Contralaterally Controlled Functional Electrical Stimulation
* Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing of the contralateral unimpaired hand
* A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity
* Therapy sessions are done with the subject being assisted by the CCFES system.
|
cNMES
n=8 Participants
cNMES - Cyclic NeuroMuscular Electrical Stimulation.
* Preprogrammed cycles of finger and thumb flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.
* Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation
* Therapy sessions are done without the stimulation system
|
|---|---|---|
|
Fugl-Meyer Assessment (Upper Extremity)
|
46.2 units on a scale
Standard Error 2.1
|
41.1 units on a scale
Standard Error 2.2
|
Adverse Events
CCFES
cNMES
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place