Trial Outcomes & Findings for Enhancing Plasticity in Stroke Patients With Severe Motor Deficit (NCT NCT02633215)
NCT ID: NCT02633215
Last Updated: 2017-08-10
Results Overview
Score after intervention minus baseline score, score at 1-month follow-up minus baseline score. The possible scores range from 0 to 66, with 66 indicating the best performance.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
baseline, post-intervention, 1-month follow-up
Results posted on
2017-08-10
Participant Flow
Participant milestones
| Measure |
Active Stimulation With Motor Training
2 hours of active peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.
S88 Dual Output Stimulator by Grass Technologies: Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy
|
Sham Stimulation With Motor Training
2 hours of sham peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.
S88 Dual Output Stimulator by Grass Technologies: Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
|
Overall Study
COMPLETED
|
16
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Active Stimulation With Motor Training
2 hours of active peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.
S88 Dual Output Stimulator by Grass Technologies: Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy
|
Sham Stimulation With Motor Training
2 hours of sham peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.
S88 Dual Output Stimulator by Grass Technologies: Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
Baseline Characteristics
Enhancing Plasticity in Stroke Patients With Severe Motor Deficit
Baseline characteristics by cohort
| Measure |
Active Stimulation With Motor Training
n=18 Participants
2 hours of active peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.
S88 Dual Output Stimulator by Grass Technologies: Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy
|
Sham Stimulation With Motor Training
n=18 Participants
2 hours of sham peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.
S88 Dual Output Stimulator by Grass Technologies: Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.7 years
STANDARD_DEVIATION 12.1 • n=99 Participants
|
65.4 years
STANDARD_DEVIATION 10.8 • n=107 Participants
|
62.1 years
STANDARD_DEVIATION 11.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: baseline, post-intervention, 1-month follow-upScore after intervention minus baseline score, score at 1-month follow-up minus baseline score. The possible scores range from 0 to 66, with 66 indicating the best performance.
Outcome measures
| Measure |
Active Stimulation With Motor Training
n=18 Participants
2 hours of active peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.
S88 Dual Output Stimulator by Grass Technologies: Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy
|
Sham Stimulation With Motor Training
n=18 Participants
2 hours of sham peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.
S88 Dual Output Stimulator by Grass Technologies: Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy
|
|---|---|---|
|
Change in Fugl Meyer Assessment Motor Score
1-month follow-up minus baseline
|
7.2 units on a scale
Standard Error 1.3
|
2.8 units on a scale
Standard Error 1.4
|
|
Change in Fugl Meyer Assessment Motor Score
Post-intervention minus baseline
|
7.4 units on a scale
Standard Error 1.0
|
3.4 units on a scale
Standard Error 1.0
|
SECONDARY outcome
Timeframe: baseline, post-intervention, 1-month follow-upScore at post-intervention minus baseline, score at 1-month follow-up minus baseline. The possible scores range from 0 to 57, with higher scores indicating better performance.
Outcome measures
| Measure |
Active Stimulation With Motor Training
n=18 Participants
2 hours of active peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.
S88 Dual Output Stimulator by Grass Technologies: Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy
|
Sham Stimulation With Motor Training
n=18 Participants
2 hours of sham peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.
S88 Dual Output Stimulator by Grass Technologies: Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy
|
|---|---|---|
|
Change in Action Arm Research Test (ARAT)
Post-intervention minus baseline
|
6.4 units on a scale
Standard Error 1.1
|
2.3 units on a scale
Standard Error 1.1
|
|
Change in Action Arm Research Test (ARAT)
1-month follow-up minus baseline
|
6.9 units on a scale
Standard Error 1.3
|
2.4 units on a scale
Standard Error 1.4
|
SECONDARY outcome
Timeframe: baseline, post-intervention, 1-month follow-upScore at post-intervention minus baseline, score at 1-month follow-up minus baseline. Each task is scored as amount of time taken to complete a task, which may range from just over 0 to 120 seconds. If the subject is unable to complete the task within 120 seconds, a score of 121 seconds is given. The scores from the 15 individual tasks are averaged, then the log is taken, resulting in the overall score. Therefore, the larger the score, the longer required to perform the tasks. Negative changes in score indicate that a subject, on average, was able to complete the tasks faster at post-intervention or at 1-month follow-up than at baseline.
Outcome measures
| Measure |
Active Stimulation With Motor Training
n=18 Participants
2 hours of active peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.
S88 Dual Output Stimulator by Grass Technologies: Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy
|
Sham Stimulation With Motor Training
n=17 Participants
2 hours of sham peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.
S88 Dual Output Stimulator by Grass Technologies: Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy
|
|---|---|---|
|
Change in Wolf Motor Function Test (WMFT)
Post-intervention minus baseline
|
-0.18 log(seconds)
Standard Error 0.03
|
-0.06 log(seconds)
Standard Error 0.03
|
|
Change in Wolf Motor Function Test (WMFT)
1-month follow-up minus baseline
|
-0.14 log(seconds)
Standard Error 0.03
|
-0.07 log(seconds)
Standard Error 0.04
|
Adverse Events
Active Stimulation With Motor Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Stimulation With Motor Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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