Trial Outcomes & Findings for Robotic Therapy and Transcranial Direct Current Stimulation in Patients With Stroke (NCT NCT02416791)
NCT ID: NCT02416791
Last Updated: 2020-10-20
Results Overview
Change in Motor function subscale was assessed. Scores range from 0 to 66. Lower scores indicate greater severity.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
9 participants
Primary outcome timeframe
6 weeks from baseline
Results posted on
2020-10-20
Participant Flow
Participant milestones
| Measure |
Active tDCS + Robotic Therapy + Physical Therapy
Active tDCS (transcranial direct current stimulation) will be applied prior to the robotic training. After robot training, the patient will receive physical therapy for 40 minutes.
Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Robotic Therapy: Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.
Active tDCS: Active tDCS will be applied with the cathode positioned over the ipsilesional primary motor cortex and the anode over the contralateral supraorbital region for 20 minutes (1mA).
Physical Therapy: Physical therapy will be administered for 40 minutes.
|
Sham tDCS + Robotic Therapy + Physical Therapy
Sham tDCS (transcranial direct current stimulation) will be applied prior to robotic training. After robot training, the patient will receive physical therapy for 40 minutes.
Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Robotic Therapy: Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.
Sham tDCS: In sham tDCS, no current will be delivered through the tDCS device.
Physical Therapy: Physical therapy will be administered for 40 minutes.
|
Sham tDCS + Physical Therapy + Occupational Therapy
Sham tDCS (transcranial direct current stimulation) will be applied prior to conventional therapy (40 minutes of physical therapy and 40 minutes of occupational therapy) Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Sham tDCS: In sham tDCS, no current will be delivered through the tDCS device.
Physical Therapy: Physical therapy will be administered for 40 minutes.
Occupational Therapy: Occupational therapy will be administered for 40 minutes.
|
|---|---|---|---|
|
6 Weeks
STARTED
|
3
|
3
|
3
|
|
6 Weeks
COMPLETED
|
3
|
3
|
3
|
|
6 Weeks
NOT COMPLETED
|
0
|
0
|
0
|
|
6 Months
STARTED
|
3
|
3
|
3
|
|
6 Months
COMPLETED
|
3
|
3
|
2
|
|
6 Months
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Active tDCS + Robotic Therapy + Physical Therapy
Active tDCS (transcranial direct current stimulation) will be applied prior to the robotic training. After robot training, the patient will receive physical therapy for 40 minutes.
Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Robotic Therapy: Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.
Active tDCS: Active tDCS will be applied with the cathode positioned over the ipsilesional primary motor cortex and the anode over the contralateral supraorbital region for 20 minutes (1mA).
Physical Therapy: Physical therapy will be administered for 40 minutes.
|
Sham tDCS + Robotic Therapy + Physical Therapy
Sham tDCS (transcranial direct current stimulation) will be applied prior to robotic training. After robot training, the patient will receive physical therapy for 40 minutes.
Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Robotic Therapy: Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.
Sham tDCS: In sham tDCS, no current will be delivered through the tDCS device.
Physical Therapy: Physical therapy will be administered for 40 minutes.
|
Sham tDCS + Physical Therapy + Occupational Therapy
Sham tDCS (transcranial direct current stimulation) will be applied prior to conventional therapy (40 minutes of physical therapy and 40 minutes of occupational therapy) Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Sham tDCS: In sham tDCS, no current will be delivered through the tDCS device.
Physical Therapy: Physical therapy will be administered for 40 minutes.
Occupational Therapy: Occupational therapy will be administered for 40 minutes.
|
|---|---|---|---|
|
6 Months
Lost to Follow-up
|
0
|
0
|
1
|
Baseline Characteristics
Robotic Therapy and Transcranial Direct Current Stimulation in Patients With Stroke
Baseline characteristics by cohort
| Measure |
Active tDCS + Robotic Therapy + Physical Therapy
n=3 Participants
Active tDCS (transcranial direct current stimulation) will be applied prior to the robotic training. After robot training, the patient will receive physical therapy for 40 minutes.
Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Robotic Therapy: Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.
Active tDCS: Active tDCS will be applied with the cathode positioned over the ipsilesional primary motor cortex and the anode over the contralateral supraorbital region for 20 minutes (1mA).
Physical Therapy: Physical therapy will be administered for 40 minutes.
|
Sham tDCS + Robotic Therapy + Physical Therapy
n=3 Participants
Sham tDCS (transcranial direct current stimulation) will be applied prior to robotic training. After robot training, the patient will receive physical therapy for 40 minutes.
Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Robotic Therapy: Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.
Sham tDCS: In sham tDCS, no current will be delivered through the tDCS device.
Physical Therapy: Physical therapy will be administered for 40 minutes.
|
Sham tDCS + Physical Therapy + Occupational Therapy
n=3 Participants
Sham tDCS (transcranial direct current stimulation) will be applied prior to conventional therapy (40 minutes of physical therapy and 40 minutes of occupational therapy) Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Sham tDCS: In sham tDCS, no current will be delivered through the tDCS device.
Physical Therapy: Physical therapy will be administered for 40 minutes.
Occupational Therapy: Occupational therapy will be administered for 40 minutes.
|
Total
n=9 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Age, Continuous
|
55.3 years
STANDARD_DEVIATION 15.2 • n=5 Participants
|
53.33 years
STANDARD_DEVIATION 4.02 • n=7 Participants
|
54.0 years
STANDARD_DEVIATION 8.52 • n=5 Participants
|
54.22 years
STANDARD_DEVIATION 10.97 • n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Back
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Time since stroke
|
49.3 days
STANDARD_DEVIATION 11.1 • n=5 Participants
|
40.0 days
STANDARD_DEVIATION 16.75 • n=7 Participants
|
36.66 days
STANDARD_DEVIATION 11.11 • n=5 Participants
|
41.56 days
STANDARD_DEVIATION 15.21 • n=4 Participants
|
|
Manual dominance
Right
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Manual dominance
Left
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Hemisphere lesioned
Right hemisphere
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Hemisphere lesioned
Left hemisphere
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Upper Extremity Fugl Meyer Assessment
|
19.3 units on a scale
STANDARD_DEVIATION 9.8 • n=5 Participants
|
17.7 units on a scale
STANDARD_DEVIATION 4.2 • n=7 Participants
|
21.7 units on a scale
STANDARD_DEVIATION 7.8 • n=5 Participants
|
18.89 units on a scale
STANDARD_DEVIATION 6.27 • n=4 Participants
|
|
Mini Mental State Exam
|
20 units on a scale
n=5 Participants
|
27 units on a scale
n=7 Participants
|
25 units on a scale
n=5 Participants
|
25 units on a scale
n=4 Participants
|
|
National Institutes of Health Stroke Scale
|
6 units on a scale
n=5 Participants
|
6 units on a scale
n=7 Participants
|
3 units on a scale
n=5 Participants
|
4 units on a scale
n=4 Participants
|
|
Modified Rankin Scale
|
3 units on a scale
n=5 Participants
|
3 units on a scale
n=7 Participants
|
3 units on a scale
n=5 Participants
|
3 units on a scale
n=4 Participants
|
|
Hospital Anxiety and Depression Scale
|
8 units on a scale
n=5 Participants
|
6 units on a scale
n=7 Participants
|
8 units on a scale
n=5 Participants
|
8 units on a scale
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 weeks from baselineChange in Motor function subscale was assessed. Scores range from 0 to 66. Lower scores indicate greater severity.
Outcome measures
| Measure |
Active tDCS + Robotic Therapy + Physical Therapy
n=3 Participants
Active tDCS (transcranial direct current stimulation) will be applied prior to the robotic training. After robot training, the patient will receive physical therapy for 40 minutes.
Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Robotic Therapy: Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.
Active tDCS: Active tDCS will be applied with the cathode positioned over the ipsilesional primary motor cortex and the anode over the contralateral supraorbital region for 20 minutes (1mA).
Physical Therapy: Physical therapy will be administered for 40 minutes.
|
Sham tDCS + Robotic Therapy + Physical Therapy
n=3 Participants
Sham tDCS (transcranial direct current stimulation) will be applied prior to robotic training. After robot training, the patient will receive physical therapy for 40 minutes.
Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Robotic Therapy: Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.
Sham tDCS: In sham tDCS, no current will be delivered through the tDCS device.
Physical Therapy: Physical therapy will be administered for 40 minutes.
|
Sham tDCS + Physical Therapy + Occupational Therapy
n=3 Participants
Sham tDCS (transcranial direct current stimulation) will be applied prior to conventional therapy (40 minutes of physical therapy and 40 minutes of occupational therapy) Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Sham tDCS: In sham tDCS, no current will be delivered through the tDCS device.
Physical Therapy: Physical therapy will be administered for 40 minutes.
Occupational Therapy: Occupational therapy will be administered for 40 minutes.
|
|---|---|---|---|
|
Change in Upper Extremity Fugl Meyer Assessment
|
10.6 score on a scale
Standard Deviation 7.3
|
12.3 score on a scale
Standard Deviation 11.4
|
22.3 score on a scale
Standard Deviation 12.4
|
PRIMARY outcome
Timeframe: Post treatment (6 weeks from baseline).Population: RT: robotic therapy; OT: occupational therapy; PT: physical therapy Sham tDCS +RT + PT: 3 participants;each participant was supposed to participate in 18 sessions = 54 sessions in total; there was seven absences and the total number of sessions was 47 for the three patients.
Outcome measures
| Measure |
Active tDCS + Robotic Therapy + Physical Therapy
n=53 Number of sessions
Active tDCS (transcranial direct current stimulation) will be applied prior to the robotic training. After robot training, the patient will receive physical therapy for 40 minutes.
Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Robotic Therapy: Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.
Active tDCS: Active tDCS will be applied with the cathode positioned over the ipsilesional primary motor cortex and the anode over the contralateral supraorbital region for 20 minutes (1mA).
Physical Therapy: Physical therapy will be administered for 40 minutes.
|
Sham tDCS + Robotic Therapy + Physical Therapy
n=47 Number of sessions
Sham tDCS (transcranial direct current stimulation) will be applied prior to robotic training. After robot training, the patient will receive physical therapy for 40 minutes.
Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Robotic Therapy: Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.
Sham tDCS: In sham tDCS, no current will be delivered through the tDCS device.
Physical Therapy: Physical therapy will be administered for 40 minutes.
|
Sham tDCS + Physical Therapy + Occupational Therapy
n=53 Number of sessions
Sham tDCS (transcranial direct current stimulation) will be applied prior to conventional therapy (40 minutes of physical therapy and 40 minutes of occupational therapy) Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Sham tDCS: In sham tDCS, no current will be delivered through the tDCS device.
Physical Therapy: Physical therapy will be administered for 40 minutes.
Occupational Therapy: Occupational therapy will be administered for 40 minutes.
|
|---|---|---|---|
|
Percentage of Sessions With Adverse Events
Dysesthesia reported during PT
|
0 percentage of sessions
|
0 percentage of sessions
|
0 percentage of sessions
|
|
Percentage of Sessions With Adverse Events
Pain reported during tDCS
|
0 percentage of sessions
|
0 percentage of sessions
|
1.9 percentage of sessions
|
|
Percentage of Sessions With Adverse Events
Fatigue reported during tDCS
|
0 percentage of sessions
|
0 percentage of sessions
|
0 percentage of sessions
|
|
Percentage of Sessions With Adverse Events
Tingling reported during tDCS
|
100 percentage of sessions
|
27.7 percentage of sessions
|
37.7 percentage of sessions
|
|
Percentage of Sessions With Adverse Events
Burning reported during tDCS
|
0 percentage of sessions
|
2.1 percentage of sessions
|
5.7 percentage of sessions
|
|
Percentage of Sessions With Adverse Events
Hot reported during tDCS
|
0 percentage of sessions
|
0 percentage of sessions
|
0 percentage of sessions
|
|
Percentage of Sessions With Adverse Events
Pinching reported during tDCS
|
9.4 percentage of sessions
|
31.9 percentage of sessions
|
30.2 percentage of sessions
|
|
Percentage of Sessions With Adverse Events
Metallic taste reported during tDCS
|
0 percentage of sessions
|
0 percentage of sessions
|
0 percentage of sessions
|
|
Percentage of Sessions With Adverse Events
Itching reported during tDCS
|
5.6 percentage of sessions
|
2.1 percentage of sessions
|
5.7 percentage of sessions
|
|
Percentage of Sessions With Adverse Events
Pain reported during RT or OT
|
5.7 percentage of sessions
|
24.3 percentage of sessions
|
7.5 percentage of sessions
|
|
Percentage of Sessions With Adverse Events
Fatigue reported during RT or OT
|
18.9 percentage of sessions
|
14 percentage of sessions
|
17 percentage of sessions
|
|
Percentage of Sessions With Adverse Events
Dizziness reported during RT or OT
|
0 percentage of sessions
|
0 percentage of sessions
|
0 percentage of sessions
|
|
Percentage of Sessions With Adverse Events
Syncope reported during RT or OT
|
0 percentage of sessions
|
0 percentage of sessions
|
0 percentage of sessions
|
|
Percentage of Sessions With Adverse Events
Seizure reported during RT or OT
|
0 percentage of sessions
|
0 percentage of sessions
|
0 percentage of sessions
|
|
Percentage of Sessions With Adverse Events
Sleepiness reported during RT or OT
|
9.4 percentage of sessions
|
6.4 percentage of sessions
|
5.7 percentage of sessions
|
|
Percentage of Sessions With Adverse Events
Dysesthesia reported during RT or OT
|
1.8 percentage of sessions
|
0 percentage of sessions
|
0 percentage of sessions
|
|
Percentage of Sessions With Adverse Events
Pain reported during PT
|
11.3 percentage of sessions
|
23.4 percentage of sessions
|
24.5 percentage of sessions
|
|
Percentage of Sessions With Adverse Events
Fatigue reported during PT
|
3.8 percentage of sessions
|
17 percentage of sessions
|
0 percentage of sessions
|
|
Percentage of Sessions With Adverse Events
Dizziness reported during PT
|
0 percentage of sessions
|
0 percentage of sessions
|
0 percentage of sessions
|
|
Percentage of Sessions With Adverse Events
Syncope reported during FT
|
0 percentage of sessions
|
0 percentage of sessions
|
0 percentage of sessions
|
|
Percentage of Sessions With Adverse Events
Seizure reported during PT
|
0 percentage of sessions
|
0 percentage of sessions
|
0 percentage of sessions
|
|
Percentage of Sessions With Adverse Events
Sleepiness reported during PT
|
1.8 percentage of sessions
|
6.4 percentage of sessions
|
5.7 percentage of sessions
|
SECONDARY outcome
Timeframe: 6 weeks from baselineScores range from 0 to 6. Higher scores indicate greater severity.
Outcome measures
| Measure |
Active tDCS + Robotic Therapy + Physical Therapy
n=3 Participants
Active tDCS (transcranial direct current stimulation) will be applied prior to the robotic training. After robot training, the patient will receive physical therapy for 40 minutes.
Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Robotic Therapy: Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.
Active tDCS: Active tDCS will be applied with the cathode positioned over the ipsilesional primary motor cortex and the anode over the contralateral supraorbital region for 20 minutes (1mA).
Physical Therapy: Physical therapy will be administered for 40 minutes.
|
Sham tDCS + Robotic Therapy + Physical Therapy
n=3 Participants
Sham tDCS (transcranial direct current stimulation) will be applied prior to robotic training. After robot training, the patient will receive physical therapy for 40 minutes.
Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Robotic Therapy: Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.
Sham tDCS: In sham tDCS, no current will be delivered through the tDCS device.
Physical Therapy: Physical therapy will be administered for 40 minutes.
|
Sham tDCS + Physical Therapy + Occupational Therapy
n=3 Participants
Sham tDCS (transcranial direct current stimulation) will be applied prior to conventional therapy (40 minutes of physical therapy and 40 minutes of occupational therapy) Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Sham tDCS: In sham tDCS, no current will be delivered through the tDCS device.
Physical Therapy: Physical therapy will be administered for 40 minutes.
Occupational Therapy: Occupational therapy will be administered for 40 minutes.
|
|---|---|---|---|
|
Change in Modified Rankin Scale
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to -1.0
|
-1 score on a scale
Interval -1.0 to -1.0
|
SECONDARY outcome
Timeframe: 6 weeks from baselineScores range from 0 to 42. Higher scores indicate greater severity.
Outcome measures
| Measure |
Active tDCS + Robotic Therapy + Physical Therapy
n=3 Participants
Active tDCS (transcranial direct current stimulation) will be applied prior to the robotic training. After robot training, the patient will receive physical therapy for 40 minutes.
Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Robotic Therapy: Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.
Active tDCS: Active tDCS will be applied with the cathode positioned over the ipsilesional primary motor cortex and the anode over the contralateral supraorbital region for 20 minutes (1mA).
Physical Therapy: Physical therapy will be administered for 40 minutes.
|
Sham tDCS + Robotic Therapy + Physical Therapy
n=3 Participants
Sham tDCS (transcranial direct current stimulation) will be applied prior to robotic training. After robot training, the patient will receive physical therapy for 40 minutes.
Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Robotic Therapy: Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.
Sham tDCS: In sham tDCS, no current will be delivered through the tDCS device.
Physical Therapy: Physical therapy will be administered for 40 minutes.
|
Sham tDCS + Physical Therapy + Occupational Therapy
n=3 Participants
Sham tDCS (transcranial direct current stimulation) will be applied prior to conventional therapy (40 minutes of physical therapy and 40 minutes of occupational therapy) Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Sham tDCS: In sham tDCS, no current will be delivered through the tDCS device.
Physical Therapy: Physical therapy will be administered for 40 minutes.
Occupational Therapy: Occupational therapy will be administered for 40 minutes.
|
|---|---|---|---|
|
Change in National Institutes of Health Stroke Scale
|
-3 score on a scale
Interval -5.0 to 0.0
|
-1 score on a scale
Interval -2.0 to -1.0
|
-2 score on a scale
Interval -3.0 to 0.0
|
SECONDARY outcome
Timeframe: 6 weeks from baselineScores in each domain of the Stroke Impact Scale range from 0 to 100, with higher scores indicating a better quality of life. The change was calculated as the value at the later time point minus the value at the earlier time point; so that, positive numbers represent increases and negative numbers represent decreases.
Outcome measures
| Measure |
Active tDCS + Robotic Therapy + Physical Therapy
n=3 Participants
Active tDCS (transcranial direct current stimulation) will be applied prior to the robotic training. After robot training, the patient will receive physical therapy for 40 minutes.
Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Robotic Therapy: Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.
Active tDCS: Active tDCS will be applied with the cathode positioned over the ipsilesional primary motor cortex and the anode over the contralateral supraorbital region for 20 minutes (1mA).
Physical Therapy: Physical therapy will be administered for 40 minutes.
|
Sham tDCS + Robotic Therapy + Physical Therapy
n=3 Participants
Sham tDCS (transcranial direct current stimulation) will be applied prior to robotic training. After robot training, the patient will receive physical therapy for 40 minutes.
Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Robotic Therapy: Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.
Sham tDCS: In sham tDCS, no current will be delivered through the tDCS device.
Physical Therapy: Physical therapy will be administered for 40 minutes.
|
Sham tDCS + Physical Therapy + Occupational Therapy
n=3 Participants
Sham tDCS (transcranial direct current stimulation) will be applied prior to conventional therapy (40 minutes of physical therapy and 40 minutes of occupational therapy) Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Sham tDCS: In sham tDCS, no current will be delivered through the tDCS device.
Physical Therapy: Physical therapy will be administered for 40 minutes.
Occupational Therapy: Occupational therapy will be administered for 40 minutes.
|
|---|---|---|---|
|
Change in Stroke Impact Scale
Strength
|
14.6 score on a scale
Standard Deviation 7.7
|
16.7 score on a scale
Standard Deviation 7.8
|
10.4 score on a scale
Standard Deviation 7.7
|
|
Change in Stroke Impact Scale
Memory
|
11.9 score on a scale
Standard Deviation 4.4
|
14.3 score on a scale
Standard Deviation 10.4
|
-1.2 score on a scale
Standard Deviation 3.6
|
|
Change in Stroke Impact Scale
Emotions
|
9.2 score on a scale
Standard Deviation 13.6
|
5.5 score on a scale
Standard Deviation 3.1
|
3.7 score on a scale
Standard Deviation 1.5
|
|
Change in Stroke Impact Scale
Comunication
|
2.3 score on a scale
Standard Deviation 6.7
|
6.0 score on a scale
Standard Deviation 1.7
|
3.6 score on a scale
Standard Deviation 4.4
|
|
Change in Stroke Impact Scale
Activities of daily living
|
14.1 score on a scale
Standard Deviation 22.4
|
25.8 score on a scale
Standard Deviation 10.0
|
20.0 score on a scale
Standard Deviation 7.8
|
|
Change in Stroke Impact Scale
Mobility
|
24.1 score on a scale
Standard Deviation 30.4
|
15.8 score on a scale
Standard Deviation 1.0
|
20.4 score on a scale
Standard Deviation 2.5
|
|
Change in Stroke Impact Scale
HandFunction
|
15.0 score on a scale
Standard Deviation 12.2
|
36.7 score on a scale
Standard Deviation 0.3
|
46.6 score on a scale
Standard Deviation 17.8
|
|
Change in Stroke Impact Scale
Participation
|
10.4 score on a scale
Standard Deviation 34.7
|
15.6 score on a scale
Standard Deviation 6.6
|
-6.2 score on a scale
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: 6 weeksScores range from 0 to 4, with 5 choices. A score of 1 indicates no resistance, and 4 indicates rigidity.
Outcome measures
| Measure |
Active tDCS + Robotic Therapy + Physical Therapy
n=3 Participants
Active tDCS (transcranial direct current stimulation) will be applied prior to the robotic training. After robot training, the patient will receive physical therapy for 40 minutes.
Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Robotic Therapy: Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.
Active tDCS: Active tDCS will be applied with the cathode positioned over the ipsilesional primary motor cortex and the anode over the contralateral supraorbital region for 20 minutes (1mA).
Physical Therapy: Physical therapy will be administered for 40 minutes.
|
Sham tDCS + Robotic Therapy + Physical Therapy
n=3 Participants
Sham tDCS (transcranial direct current stimulation) will be applied prior to robotic training. After robot training, the patient will receive physical therapy for 40 minutes.
Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Robotic Therapy: Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.
Sham tDCS: In sham tDCS, no current will be delivered through the tDCS device.
Physical Therapy: Physical therapy will be administered for 40 minutes.
|
Sham tDCS + Physical Therapy + Occupational Therapy
n=3 Participants
Sham tDCS (transcranial direct current stimulation) will be applied prior to conventional therapy (40 minutes of physical therapy and 40 minutes of occupational therapy) Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Sham tDCS: In sham tDCS, no current will be delivered through the tDCS device.
Physical Therapy: Physical therapy will be administered for 40 minutes.
Occupational Therapy: Occupational therapy will be administered for 40 minutes.
|
|---|---|---|---|
|
Number of Participants Who Presented Score on Modified Ashworth Scale >2
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 6 weeks from baselineEach domain contains taks scored on 0 to 5 ordinal scale. Lower scores indicate greater severity.
Outcome measures
| Measure |
Active tDCS + Robotic Therapy + Physical Therapy
n=3 Participants
Active tDCS (transcranial direct current stimulation) will be applied prior to the robotic training. After robot training, the patient will receive physical therapy for 40 minutes.
Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Robotic Therapy: Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.
Active tDCS: Active tDCS will be applied with the cathode positioned over the ipsilesional primary motor cortex and the anode over the contralateral supraorbital region for 20 minutes (1mA).
Physical Therapy: Physical therapy will be administered for 40 minutes.
|
Sham tDCS + Robotic Therapy + Physical Therapy
n=3 Participants
Sham tDCS (transcranial direct current stimulation) will be applied prior to robotic training. After robot training, the patient will receive physical therapy for 40 minutes.
Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Robotic Therapy: Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.
Sham tDCS: In sham tDCS, no current will be delivered through the tDCS device.
Physical Therapy: Physical therapy will be administered for 40 minutes.
|
Sham tDCS + Physical Therapy + Occupational Therapy
n=3 Participants
Sham tDCS (transcranial direct current stimulation) will be applied prior to conventional therapy (40 minutes of physical therapy and 40 minutes of occupational therapy) Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Sham tDCS: In sham tDCS, no current will be delivered through the tDCS device.
Physical Therapy: Physical therapy will be administered for 40 minutes.
Occupational Therapy: Occupational therapy will be administered for 40 minutes.
|
|---|---|---|---|
|
Change in Motor Activity Log
Amount of Movement
|
0.6 score on a scale
Standard Deviation 0.4
|
0.4 score on a scale
Standard Deviation 0.4
|
0.6 score on a scale
Standard Deviation 0.2
|
|
Change in Motor Activity Log
Quality of Movement
|
0.6 score on a scale
Standard Deviation 0.4
|
0.5 score on a scale
Standard Deviation 0.6
|
0.8 score on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: 6 months follow-upMotor function subscale was assessed. Scores range from 0 to 66. Lower scores indicate greater severity.
Outcome measures
| Measure |
Active tDCS + Robotic Therapy + Physical Therapy
n=3 Participants
Active tDCS (transcranial direct current stimulation) will be applied prior to the robotic training. After robot training, the patient will receive physical therapy for 40 minutes.
Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Robotic Therapy: Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.
Active tDCS: Active tDCS will be applied with the cathode positioned over the ipsilesional primary motor cortex and the anode over the contralateral supraorbital region for 20 minutes (1mA).
Physical Therapy: Physical therapy will be administered for 40 minutes.
|
Sham tDCS + Robotic Therapy + Physical Therapy
n=3 Participants
Sham tDCS (transcranial direct current stimulation) will be applied prior to robotic training. After robot training, the patient will receive physical therapy for 40 minutes.
Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Robotic Therapy: Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.
Sham tDCS: In sham tDCS, no current will be delivered through the tDCS device.
Physical Therapy: Physical therapy will be administered for 40 minutes.
|
Sham tDCS + Physical Therapy + Occupational Therapy
n=2 Participants
Sham tDCS (transcranial direct current stimulation) will be applied prior to conventional therapy (40 minutes of physical therapy and 40 minutes of occupational therapy) Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Sham tDCS: In sham tDCS, no current will be delivered through the tDCS device.
Physical Therapy: Physical therapy will be administered for 40 minutes.
Occupational Therapy: Occupational therapy will be administered for 40 minutes.
|
|---|---|---|---|
|
Upper Extremity Fugl Meyer Assessment
|
42 score on a scale
Standard Deviation 13
|
34 score on a scale
Standard Deviation 14.9
|
44.5 score on a scale
Standard Deviation 15.5
|
SECONDARY outcome
Timeframe: 6 months follow-upOutcome measures
| Measure |
Active tDCS + Robotic Therapy + Physical Therapy
n=3 Participants
Active tDCS (transcranial direct current stimulation) will be applied prior to the robotic training. After robot training, the patient will receive physical therapy for 40 minutes.
Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Robotic Therapy: Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.
Active tDCS: Active tDCS will be applied with the cathode positioned over the ipsilesional primary motor cortex and the anode over the contralateral supraorbital region for 20 minutes (1mA).
Physical Therapy: Physical therapy will be administered for 40 minutes.
|
Sham tDCS + Robotic Therapy + Physical Therapy
n=3 Participants
Sham tDCS (transcranial direct current stimulation) will be applied prior to robotic training. After robot training, the patient will receive physical therapy for 40 minutes.
Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Robotic Therapy: Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.
Sham tDCS: In sham tDCS, no current will be delivered through the tDCS device.
Physical Therapy: Physical therapy will be administered for 40 minutes.
|
Sham tDCS + Physical Therapy + Occupational Therapy
n=2 Participants
Sham tDCS (transcranial direct current stimulation) will be applied prior to conventional therapy (40 minutes of physical therapy and 40 minutes of occupational therapy) Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Sham tDCS: In sham tDCS, no current will be delivered through the tDCS device.
Physical Therapy: Physical therapy will be administered for 40 minutes.
Occupational Therapy: Occupational therapy will be administered for 40 minutes.
|
|---|---|---|---|
|
Number of Participants With Adverse Events
headache
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events
pain on shoulder mobilization
|
1 participants
|
2 participants
|
1 participants
|
|
Number of Participants With Adverse Events
dizziness
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events
syncope
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events
seizures
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events
dysesthesia
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events
psychiatric disorder
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events
sleep
|
0 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 6 weeks from baselineFatigue Severity Scale is a 9 -item questionnaire. Each item scores on a 7-point scale. The total score range from 9 to 63 points. Higher scores indicate greater fatigue.
Outcome measures
| Measure |
Active tDCS + Robotic Therapy + Physical Therapy
n=3 Participants
Active tDCS (transcranial direct current stimulation) will be applied prior to the robotic training. After robot training, the patient will receive physical therapy for 40 minutes.
Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Robotic Therapy: Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.
Active tDCS: Active tDCS will be applied with the cathode positioned over the ipsilesional primary motor cortex and the anode over the contralateral supraorbital region for 20 minutes (1mA).
Physical Therapy: Physical therapy will be administered for 40 minutes.
|
Sham tDCS + Robotic Therapy + Physical Therapy
n=3 Participants
Sham tDCS (transcranial direct current stimulation) will be applied prior to robotic training. After robot training, the patient will receive physical therapy for 40 minutes.
Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Robotic Therapy: Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.
Sham tDCS: In sham tDCS, no current will be delivered through the tDCS device.
Physical Therapy: Physical therapy will be administered for 40 minutes.
|
Sham tDCS + Physical Therapy + Occupational Therapy
n=3 Participants
Sham tDCS (transcranial direct current stimulation) will be applied prior to conventional therapy (40 minutes of physical therapy and 40 minutes of occupational therapy) Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Sham tDCS: In sham tDCS, no current will be delivered through the tDCS device.
Physical Therapy: Physical therapy will be administered for 40 minutes.
Occupational Therapy: Occupational therapy will be administered for 40 minutes.
|
|---|---|---|---|
|
Change in Fatigue Severity Scale
|
1.7 score on a scale
Standard Deviation 11.4
|
-1.7 score on a scale
Standard Deviation 16.3
|
-30.7 score on a scale
Standard Deviation 13.7
|
SECONDARY outcome
Timeframe: 6 weeks from baselineThe global Pittsburgh Sleep Quality Index score is calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21. Lower scores denote a healthier sleep quality.
Outcome measures
| Measure |
Active tDCS + Robotic Therapy + Physical Therapy
n=3 Participants
Active tDCS (transcranial direct current stimulation) will be applied prior to the robotic training. After robot training, the patient will receive physical therapy for 40 minutes.
Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Robotic Therapy: Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.
Active tDCS: Active tDCS will be applied with the cathode positioned over the ipsilesional primary motor cortex and the anode over the contralateral supraorbital region for 20 minutes (1mA).
Physical Therapy: Physical therapy will be administered for 40 minutes.
|
Sham tDCS + Robotic Therapy + Physical Therapy
n=3 Participants
Sham tDCS (transcranial direct current stimulation) will be applied prior to robotic training. After robot training, the patient will receive physical therapy for 40 minutes.
Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Robotic Therapy: Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.
Sham tDCS: In sham tDCS, no current will be delivered through the tDCS device.
Physical Therapy: Physical therapy will be administered for 40 minutes.
|
Sham tDCS + Physical Therapy + Occupational Therapy
n=3 Participants
Sham tDCS (transcranial direct current stimulation) will be applied prior to conventional therapy (40 minutes of physical therapy and 40 minutes of occupational therapy) Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Sham tDCS: In sham tDCS, no current will be delivered through the tDCS device.
Physical Therapy: Physical therapy will be administered for 40 minutes.
Occupational Therapy: Occupational therapy will be administered for 40 minutes.
|
|---|---|---|---|
|
Change in Pittsburgh Sleep Quality Index
|
-1.0 score on a scale
Standard Deviation 1.0
|
-2.3 score on a scale
Standard Deviation 2.5
|
0.3 score on a scale
Standard Deviation 3.1
|
Adverse Events
Active tDCS + Robotic Therapy + Physical Therapy
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Sham tDCS + Robotic Therapy + Physical Therapy
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Sham tDCS + Physical Therapy + Occupational Therapy
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active tDCS + Robotic Therapy + Physical Therapy
n=3 participants at risk
Active tDCS (transcranial direct current stimulation) will be applied prior to the robotic training. After robot training, the patient will receive physical therapy for 40 minutes.
Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Robotic Therapy: Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.
Active tDCS: Active tDCS will be applied with the cathode positioned over the ipsilesional primary motor cortex and the anode over the contralateral supraorbital region for 20 minutes (1mA).
Physical Therapy: Physical therapy will be administered for 40 minutes.
|
Sham tDCS + Robotic Therapy + Physical Therapy
n=3 participants at risk
Sham tDCS (transcranial direct current stimulation) will be applied prior to robotic training. After robot training, the patient will receive physical therapy for 40 minutes.
Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Robotic Therapy: Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.
Sham tDCS: In sham tDCS, no current will be delivered through the tDCS device.
Physical Therapy: Physical therapy will be administered for 40 minutes.
|
Sham tDCS + Physical Therapy + Occupational Therapy
n=3 participants at risk
Sham tDCS (transcranial direct current stimulation) will be applied prior to conventional therapy (40 minutes of physical therapy and 40 minutes of occupational therapy) Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Sham tDCS: In sham tDCS, no current will be delivered through the tDCS device.
Physical Therapy: Physical therapy will be administered for 40 minutes.
Occupational Therapy: Occupational therapy will be administered for 40 minutes.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Tingling
|
100.0%
3/3 • Number of events 53 • 06 months
Data about adverse effect were collected in each session of treatment, for each different intervention - tDCS, Physical Therapy, and motor therapy (Robotic therapy or Occupational Therapy). All minor adverse events related (tingling, pinching, fatigue, pain, sleepiness, fatigue and pain) were considered treatment-related and reported to Ethical Committee. Two events of fall outside the hospital were related and considered non-treatment-related.
|
100.0%
3/3 • Number of events 13 • 06 months
Data about adverse effect were collected in each session of treatment, for each different intervention - tDCS, Physical Therapy, and motor therapy (Robotic therapy or Occupational Therapy). All minor adverse events related (tingling, pinching, fatigue, pain, sleepiness, fatigue and pain) were considered treatment-related and reported to Ethical Committee. Two events of fall outside the hospital were related and considered non-treatment-related.
|
66.7%
2/3 • Number of events 20 • 06 months
Data about adverse effect were collected in each session of treatment, for each different intervention - tDCS, Physical Therapy, and motor therapy (Robotic therapy or Occupational Therapy). All minor adverse events related (tingling, pinching, fatigue, pain, sleepiness, fatigue and pain) were considered treatment-related and reported to Ethical Committee. Two events of fall outside the hospital were related and considered non-treatment-related.
|
|
Skin and subcutaneous tissue disorders
Pinching
|
33.3%
1/3 • Number of events 5 • 06 months
Data about adverse effect were collected in each session of treatment, for each different intervention - tDCS, Physical Therapy, and motor therapy (Robotic therapy or Occupational Therapy). All minor adverse events related (tingling, pinching, fatigue, pain, sleepiness, fatigue and pain) were considered treatment-related and reported to Ethical Committee. Two events of fall outside the hospital were related and considered non-treatment-related.
|
100.0%
3/3 • Number of events 15 • 06 months
Data about adverse effect were collected in each session of treatment, for each different intervention - tDCS, Physical Therapy, and motor therapy (Robotic therapy or Occupational Therapy). All minor adverse events related (tingling, pinching, fatigue, pain, sleepiness, fatigue and pain) were considered treatment-related and reported to Ethical Committee. Two events of fall outside the hospital were related and considered non-treatment-related.
|
66.7%
2/3 • Number of events 16 • 06 months
Data about adverse effect were collected in each session of treatment, for each different intervention - tDCS, Physical Therapy, and motor therapy (Robotic therapy or Occupational Therapy). All minor adverse events related (tingling, pinching, fatigue, pain, sleepiness, fatigue and pain) were considered treatment-related and reported to Ethical Committee. Two events of fall outside the hospital were related and considered non-treatment-related.
|
|
Musculoskeletal and connective tissue disorders
Fatigue
|
66.7%
2/3 • Number of events 2 • 06 months
Data about adverse effect were collected in each session of treatment, for each different intervention - tDCS, Physical Therapy, and motor therapy (Robotic therapy or Occupational Therapy). All minor adverse events related (tingling, pinching, fatigue, pain, sleepiness, fatigue and pain) were considered treatment-related and reported to Ethical Committee. Two events of fall outside the hospital were related and considered non-treatment-related.
|
66.7%
2/3 • Number of events 8 • 06 months
Data about adverse effect were collected in each session of treatment, for each different intervention - tDCS, Physical Therapy, and motor therapy (Robotic therapy or Occupational Therapy). All minor adverse events related (tingling, pinching, fatigue, pain, sleepiness, fatigue and pain) were considered treatment-related and reported to Ethical Committee. Two events of fall outside the hospital were related and considered non-treatment-related.
|
0.00%
0/3 • 06 months
Data about adverse effect were collected in each session of treatment, for each different intervention - tDCS, Physical Therapy, and motor therapy (Robotic therapy or Occupational Therapy). All minor adverse events related (tingling, pinching, fatigue, pain, sleepiness, fatigue and pain) were considered treatment-related and reported to Ethical Committee. Two events of fall outside the hospital were related and considered non-treatment-related.
|
|
Musculoskeletal and connective tissue disorders
Pain
|
100.0%
3/3 • Number of events 6 • 06 months
Data about adverse effect were collected in each session of treatment, for each different intervention - tDCS, Physical Therapy, and motor therapy (Robotic therapy or Occupational Therapy). All minor adverse events related (tingling, pinching, fatigue, pain, sleepiness, fatigue and pain) were considered treatment-related and reported to Ethical Committee. Two events of fall outside the hospital were related and considered non-treatment-related.
|
66.7%
2/3 • Number of events 11 • 06 months
Data about adverse effect were collected in each session of treatment, for each different intervention - tDCS, Physical Therapy, and motor therapy (Robotic therapy or Occupational Therapy). All minor adverse events related (tingling, pinching, fatigue, pain, sleepiness, fatigue and pain) were considered treatment-related and reported to Ethical Committee. Two events of fall outside the hospital were related and considered non-treatment-related.
|
33.3%
1/3 • Number of events 13 • 06 months
Data about adverse effect were collected in each session of treatment, for each different intervention - tDCS, Physical Therapy, and motor therapy (Robotic therapy or Occupational Therapy). All minor adverse events related (tingling, pinching, fatigue, pain, sleepiness, fatigue and pain) were considered treatment-related and reported to Ethical Committee. Two events of fall outside the hospital were related and considered non-treatment-related.
|
|
Nervous system disorders
Sleepiness
|
66.7%
2/3 • Number of events 5 • 06 months
Data about adverse effect were collected in each session of treatment, for each different intervention - tDCS, Physical Therapy, and motor therapy (Robotic therapy or Occupational Therapy). All minor adverse events related (tingling, pinching, fatigue, pain, sleepiness, fatigue and pain) were considered treatment-related and reported to Ethical Committee. Two events of fall outside the hospital were related and considered non-treatment-related.
|
33.3%
1/3 • Number of events 3 • 06 months
Data about adverse effect were collected in each session of treatment, for each different intervention - tDCS, Physical Therapy, and motor therapy (Robotic therapy or Occupational Therapy). All minor adverse events related (tingling, pinching, fatigue, pain, sleepiness, fatigue and pain) were considered treatment-related and reported to Ethical Committee. Two events of fall outside the hospital were related and considered non-treatment-related.
|
66.7%
2/3 • Number of events 3 • 06 months
Data about adverse effect were collected in each session of treatment, for each different intervention - tDCS, Physical Therapy, and motor therapy (Robotic therapy or Occupational Therapy). All minor adverse events related (tingling, pinching, fatigue, pain, sleepiness, fatigue and pain) were considered treatment-related and reported to Ethical Committee. Two events of fall outside the hospital were related and considered non-treatment-related.
|
Additional Information
Professor Adriana Bastos Conforto
Neurostimulation Laboratory, Hospital das Clínicas/São Paulo University, Brazil
Phone: +55 11 2661-7955
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place