Trial Outcomes & Findings for Functional Electrical Stimulation (FES) for Upper Extremity Recovery in Stroke (NCT NCT00142792)
NCT ID: NCT00142792
Last Updated: 2018-03-29
Results Overview
The FMA battery measures six dimensions of post-stroke impairment including upper and lower limb motor impairment, range of motion, pain, reflexes, and sensation. , "Each item (33 total) is graded on a 3-point ordinal scale (0, cannot perform; 1, perform partially; and 2, perform fully) and summed to provide a score ranging from 0 to 66, where higher scores indicate better motor function The FMA was administered with the participant seated.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
122 participants
Primary outcome timeframe
FMA will be administered on 6 occasions: at baseline, mid-treatment, end of treatment, and follow-up at 1-,3- and 6-months post-treatment.
Results posted on
2018-03-29
Participant Flow
Participant milestones
| Measure |
A. Cyclic Stim
* Preprogrammed cycles of finger and thumb flexor and extensor stimulation (and flexor stimulation if deemed necessary by the PI) 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
NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles.
|
C. EMG-Triggered
EMG-Triggered electrical stimulation. Subjects in this group will attempt to extend their affected wrist and fingers in response to an audio cue. They will be "rewarded" with stimulation to cause full hand opening once they have generated EMG sufficient to reach a preset threshold level.
NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles.
|
B. Sensory Stim
Sensory-only electrical stimulation. The stimulation will be cyclic in nature but intensity will be set to a level that can be felt by the patient but not sufficient to cause muscle contraction.
NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles.
|
|---|---|---|---|
|
Overall Study
STARTED
|
39
|
41
|
42
|
|
Overall Study
Completed Intervention
|
35
|
37
|
37
|
|
Overall Study
COMPLETED
|
27
|
26
|
30
|
|
Overall Study
NOT COMPLETED
|
12
|
15
|
12
|
Reasons for withdrawal
| Measure |
A. Cyclic Stim
* Preprogrammed cycles of finger and thumb flexor and extensor stimulation (and flexor stimulation if deemed necessary by the PI) 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
NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles.
|
C. EMG-Triggered
EMG-Triggered electrical stimulation. Subjects in this group will attempt to extend their affected wrist and fingers in response to an audio cue. They will be "rewarded" with stimulation to cause full hand opening once they have generated EMG sufficient to reach a preset threshold level.
NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles.
|
B. Sensory Stim
Sensory-only electrical stimulation. The stimulation will be cyclic in nature but intensity will be set to a level that can be felt by the patient but not sufficient to cause muscle contraction.
NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles.
|
|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
8
|
11
|
7
|
|
Overall Study
No category
|
1
|
2
|
1
|
Baseline Characteristics
Functional Electrical Stimulation (FES) for Upper Extremity Recovery in Stroke
Baseline characteristics by cohort
| Measure |
A. Cyclic Stim
n=39 Participants
* Preprogrammed cycles of finger and thumb flexor and extensor stimulation (and flexor stimulation if deemed necessary by the PI) 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
NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles.
|
C. EMG-Triggered
n=41 Participants
EMG-Triggered electrical stimulation. Subjects in this group will attempt to extend their affected wrist and fingers in response to an audio cue. They will be "rewarded" with stimulation to cause full hand opening once they have generated EMG sufficient to reach a preset threshold level.
NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles.
|
B. Sensory Stim
n=42 Participants
Sensory-only electrical stimulation. The stimulation will be cyclic in nature but intensity will be set to a level that can be felt by the patient but not sufficient to cause muscle contraction.
NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles.
|
Total
n=122 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55.0 years
n=5 Participants
|
58.6 years
n=7 Participants
|
55.8 years
n=5 Participants
|
55.1 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
119 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
87 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=5 Participants
|
41 participants
n=7 Participants
|
42 participants
n=5 Participants
|
122 participants
n=4 Participants
|
|
Months from Stroke
|
2.0 months
n=5 Participants
|
2.9 months
n=7 Participants
|
3.2 months
n=5 Participants
|
2.8 months
n=4 Participants
|
PRIMARY outcome
Timeframe: FMA will be administered on 6 occasions: at baseline, mid-treatment, end of treatment, and follow-up at 1-,3- and 6-months post-treatment.Population: All cases, intent-to-treat, adjusted for site
The FMA battery measures six dimensions of post-stroke impairment including upper and lower limb motor impairment, range of motion, pain, reflexes, and sensation. , "Each item (33 total) is graded on a 3-point ordinal scale (0, cannot perform; 1, perform partially; and 2, perform fully) and summed to provide a score ranging from 0 to 66, where higher scores indicate better motor function The FMA was administered with the participant seated.
Outcome measures
| Measure |
A. Cyclic Stim
n=39 Participants
* Preprogrammed cycles of finger and thumb flexor and extensor stimulation (and flexor stimulation if deemed necessary by the PI) 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
NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles.
|
C. EMG-Triggered
n=41 Participants
EMG-Triggered electrical stimulation. Subjects in this group will attempt to extend their affected wrist and fingers in response to an audio cue. They will be "rewarded" with stimulation to cause full hand opening once they have generated EMG sufficient to reach a preset threshold level.
NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles.
|
B. Sensory Stim
n=42 Participants
Sensory-only electrical stimulation. The stimulation will be cyclic in nature but intensity will be set to a level that can be felt by the patient but not sufficient to cause muscle contraction.
NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles.
|
|---|---|---|---|
|
Fugl-Meyer Motor Assessment (FMA) - Motor Impairment Measure
Baseline
|
27.5 units on a scale
Interval 23.4 to 31.6
|
29.8 units on a scale
Interval 25.7 to 33.9
|
26.8 units on a scale
Interval 22.9 to 30.6
|
|
Fugl-Meyer Motor Assessment (FMA) - Motor Impairment Measure
Mid Treatment
|
31.8 units on a scale
Interval 27.6 to 36.1
|
32.6 units on a scale
Interval 28.2 to 37.0
|
30.4 units on a scale
Interval 26.4 to 34.4
|
|
Fugl-Meyer Motor Assessment (FMA) - Motor Impairment Measure
End of Treatment
|
34.6 units on a scale
Interval 30.5 to 38.7
|
34.7 units on a scale
Interval 30.0 to 39.5
|
33.6 units on a scale
Interval 29.1 to 38.1
|
|
Fugl-Meyer Motor Assessment (FMA) - Motor Impairment Measure
1 month after treatment
|
33.6 units on a scale
Interval 31.1 to 39.6
|
36.3 units on a scale
Interval 31.7 to 41.0
|
35.2 units on a scale
Interval 30.4 to 39.9
|
|
Fugl-Meyer Motor Assessment (FMA) - Motor Impairment Measure
3 months after treatment
|
37.9 units on a scale
Interval 33.6 to 42.1
|
39.3 units on a scale
Interval 34.4 to 44.2
|
37.3 units on a scale
Interval 32.8 to 41.8
|
|
Fugl-Meyer Motor Assessment (FMA) - Motor Impairment Measure
6 months after treatment
|
39.3 units on a scale
Interval 34.8 to 43.8
|
39.5 units on a scale
Interval 34.7 to 44.3
|
37.6 units on a scale
Interval 32.6 to 42.5
|
SECONDARY outcome
Timeframe: AMAT will be administered on 6 occasions as above: at baseline, mid-treatment, end of treatment, and follow-up at 1-,3- and 6-months post-treatment.Population: All cases, intent to treat
The AMAT assesses upper limb specific tasks and does not allow for compensation. The AMAT consists of 13 compound ADL tasks composed of 1 to 3 component tasks, with a total of 28 component tasks. Each task was rated on the functional ability ordinal scale from 0-5 and an average is calculated, so the final score remains 0-5, with higher scores indicating lesser activity limitation. Total range of reported data is between 0 and 5 because the average is reported. 0 refers to no function. 5 refers to normal function.
Outcome measures
| Measure |
A. Cyclic Stim
n=39 Participants
* Preprogrammed cycles of finger and thumb flexor and extensor stimulation (and flexor stimulation if deemed necessary by the PI) 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
NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles.
|
C. EMG-Triggered
n=41 Participants
EMG-Triggered electrical stimulation. Subjects in this group will attempt to extend their affected wrist and fingers in response to an audio cue. They will be "rewarded" with stimulation to cause full hand opening once they have generated EMG sufficient to reach a preset threshold level.
NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles.
|
B. Sensory Stim
n=42 Participants
Sensory-only electrical stimulation. The stimulation will be cyclic in nature but intensity will be set to a level that can be felt by the patient but not sufficient to cause muscle contraction.
NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles.
|
|---|---|---|---|
|
Arm Motor Ability Test (AMAT) - Hemiparetic Arm-specific Measure of Activity Limitation
Baseline
|
1.7 units on a scale
Interval 1.4 to 2.0
|
2.0 units on a scale
Interval 1.6 to 2.4
|
1.7 units on a scale
Interval 1.3 to 2.0
|
|
Arm Motor Ability Test (AMAT) - Hemiparetic Arm-specific Measure of Activity Limitation
Mid Treatment
|
2.2 units on a scale
Interval 1.9 to 2.6
|
2.3 units on a scale
Interval 1.9 to 2.7
|
2.0 units on a scale
Interval 1.6 to 2.3
|
|
Arm Motor Ability Test (AMAT) - Hemiparetic Arm-specific Measure of Activity Limitation
End of Treatment
|
2.4 units on a scale
Interval 2.0 to 2.8
|
2.4 units on a scale
Interval 2.0 to 2.9
|
2.1 units on a scale
Interval 1.7 to 2.5
|
|
Arm Motor Ability Test (AMAT) - Hemiparetic Arm-specific Measure of Activity Limitation
1 month after treatment
|
2.6 units on a scale
Interval 2.2 to 3.0
|
2.5 units on a scale
Interval 2.1 to 3.0
|
2.3 units on a scale
Interval 2.0 to 2.7
|
|
Arm Motor Ability Test (AMAT) - Hemiparetic Arm-specific Measure of Activity Limitation
3 months after treatment
|
2.7 units on a scale
Interval 2.3 to 3.1
|
2.8 units on a scale
Interval 2.3 to 3.2
|
2.5 units on a scale
Interval 2.1 to 2.9
|
|
Arm Motor Ability Test (AMAT) - Hemiparetic Arm-specific Measure of Activity Limitation
6 months after treatment
|
2.9 units on a scale
Interval 2.5 to 3.4
|
2.8 units on a scale
Interval 2.3 to 3.2
|
2.7 units on a scale
Interval 2.2 to 3.1
|
Adverse Events
A. Cyclic Stim
Serious events: 10 serious events
Other events: 1 other events
Deaths: 0 deaths
C. EMG-Triggered
Serious events: 13 serious events
Other events: 3 other events
Deaths: 0 deaths
B. Sensory Stim
Serious events: 9 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
A. Cyclic Stim
n=39 participants at risk
* Preprogrammed cycles of finger and thumb flexor and extensor stimulation (and flexor stimulation if deemed necessary by the PI) 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
NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles.
|
C. EMG-Triggered
n=41 participants at risk
EMG-Triggered electrical stimulation. Subjects in this group will attempt to extend their affected wrist and fingers in response to an audio cue. They will be "rewarded" with stimulation to cause full hand opening once they have generated EMG sufficient to reach a preset threshold level.
NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles.
|
B. Sensory Stim
n=42 participants at risk
Sensory-only electrical stimulation. The stimulation will be cyclic in nature but intensity will be set to a level that can be felt by the patient but not sufficient to cause muscle contraction.
NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles.
|
|---|---|---|---|
|
General disorders
Illness, +/- hospitalization
|
12.8%
5/39 • Number of events 8
|
17.1%
7/41 • Number of events 7
|
11.9%
5/42 • Number of events 5
|
|
General disorders
Fall
|
5.1%
2/39 • Number of events 2
|
0.00%
0/41
|
2.4%
1/42 • Number of events 1
|
|
Investigations
Surgery or procedure
|
2.6%
1/39 • Number of events 1
|
9.8%
4/41 • Number of events 5
|
0.00%
0/42
|
|
Nervous system disorders
Seizure
|
0.00%
0/39
|
4.9%
2/41 • Number of events 2
|
2.4%
1/42 • Number of events 1
|
|
General disorders
Other
|
10.3%
4/39 • Number of events 4
|
14.6%
6/41 • Number of events 7
|
4.8%
2/42 • Number of events 2
|
Other adverse events
| Measure |
A. Cyclic Stim
n=39 participants at risk
* Preprogrammed cycles of finger and thumb flexor and extensor stimulation (and flexor stimulation if deemed necessary by the PI) 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
NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles.
|
C. EMG-Triggered
n=41 participants at risk
EMG-Triggered electrical stimulation. Subjects in this group will attempt to extend their affected wrist and fingers in response to an audio cue. They will be "rewarded" with stimulation to cause full hand opening once they have generated EMG sufficient to reach a preset threshold level.
NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles.
|
B. Sensory Stim
n=42 participants at risk
Sensory-only electrical stimulation. The stimulation will be cyclic in nature but intensity will be set to a level that can be felt by the patient but not sufficient to cause muscle contraction.
NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Shock
|
0.00%
0/39
|
7.3%
3/41 • Number of events 3
|
4.8%
2/42 • Number of events 2
|
|
Nervous system disorders
Muscle Twitch
|
2.6%
1/39 • Number of events 1
|
0.00%
0/41
|
0.00%
0/42
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place