Stroke
Conditions
Keywords
robotic therapy, transcranial direct current stimulation
Brief summary
Stroke is the second cause of death worldwide and represented the first cause of death in Brazil between 2006 and 2010. Most patients survive, and there is a need to develop cost-effective rehabilitation strategies to decrease the burden of disability from stroke. This study addresses this important issue, by combining two different interventions in the early phase post-stroke: robotic therapy associated or not with transcranial direct current stimulation (tDCS), as adjuvant interventions to conventional physical therapy, for motor upper limb rehabilitation.
Detailed description
Our main goal is to confirm the safety of robotic therapy associated with active tDCS and conventional therapy, compared to robotic therapy associated with sham tDCS and to conventional therapy, and to conventional therapy alone, for upper limb rehabilitation in an early phase (3-9 weeks) after stroke. Patients will be randomized to receive one of these three treatments, 3 times per week, for 6 weeks. Data about eventual adverse effect will be collected in each session of treatment. The working hypothesis is that robotic therapy associated with active tDCS and conventional therapy will be as safe as robotic therapy associated with conventional therapy, and as conventional therapy alone. We will aso preliminarily evaluate the efficacy of robotic therapy associated with active tDCS and conventional therapy, compared to robotic therapy associated with sham tDCS and to conventional therapy alone, in improvement of upper limb motor impairment. Our secondary goals are: 1) To evaluate safety and upper limb motor impairments in patients submitted to each of the three interventions, 6 months after end of treatment; 2) To compare effects of the abovementioned interventions on disability, spasticity and quality of life, in patients at an early stage after stroke, immediately after treatment and 6 months later. The working hypothesis is that the association of robotic therapy, tDCS and conventional therapy will lead to better outcomes than robotic therapy and conventional therapy, or conventional therapy alone. Patients will be assessed before the first session and after the last session of treatment, as well as 6 months after the last session of treatment.
Interventions
DEVICERobotic Therapy
Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.
DEVICEActive 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).
DEVICESham tDCS
In sham tDCS, no current will be delivered through the tDCS device.
OTHERPhysical Therapy
Physical therapy will be administered for 40 minutes.
OTHEROccupational Therapy
Occupational therapy will be administered for 40 minutes.
Sponsors
Conselho Nacional de Desenvolvimento Científico e Tecnológico
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ischemic or hemorrhagic stroke onset 3 - 9 weeks before the recruiting, confirmed by computed tomography or magnetic resonance imaging. * Moderate to severe motor impairment of an upper limb, defined as a score between 7 - 42 on the Upper Limb Subscale of Fugl Meyer Assessment of Sensorimotor Recovery after stroke. * Ability to provide written informed consent (patient ou legal representative) * Ability to comply with the schedule of interventions and evaluations in the protocol.
Exclusion criteria
* Severe spasticity at the paretic elbow, wrist or fingers, defined as a score of \> 3 on the Modified Ashworth Spasticity Scale. * Upper limb plegia * Uncontrolled medical problems such as end-stage cancer or renal disease * Pregnancy * Seizures, except for a single seizure during the first week post stroke * Pacemakers * Other neurological disorders such as Parkinson's disease * Psychiatric illness including severe depression * Aphasia ou severe cognitive deficits that compromise comprehension of the experimental protocol or ability to provide consent. * Hemineglect * Drugs that interfere on cortical excitability, except for antidepressants * Cerebellar lesions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Upper Extremity Fugl Meyer Assessment | 6 weeks from baseline | Change in Motor function subscale was assessed. Scores range from 0 to 66. Lower scores indicate greater severity. |
| Percentage of Sessions With Adverse Events | Post treatment (6 weeks from baseline). | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Stroke Impact Scale | 6 weeks from baseline | Scores 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. |
| Number of Participants Who Presented Score on Modified Ashworth Scale >2 | 6 weeks | Scores range from 0 to 4, with 5 choices. A score of 1 indicates no resistance, and 4 indicates rigidity. |
| Change in Motor Activity Log | 6 weeks from baseline | Each domain contains taks scored on 0 to 5 ordinal scale. Lower scores indicate greater severity. |
| Change in Modified Rankin Scale | 6 weeks from baseline | Scores range from 0 to 6. Higher scores indicate greater severity. |
| Number of Participants With Adverse Events | 6 months follow-up | — |
| Change in Fatigue Severity Scale | 6 weeks from baseline | Fatigue 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. |
| Change in Pittsburgh Sleep Quality Index | 6 weeks from baseline | The 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. |
| Upper Extremity Fugl Meyer Assessment | 6 months follow-up | Motor function subscale was assessed. Scores range from 0 to 66. Lower scores indicate greater severity. |
| Change in National Institutes of Health Stroke Scale | 6 weeks from baseline | Scores range from 0 to 42. Higher scores indicate greater severity. |
Countries
Brazil
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 3 |
| 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. | 3 |
| 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. | 3 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| 6 Months | Lost to Follow-up | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Active tDCS + Robotic Therapy + Physical Therapy | Sham tDCS + Robotic Therapy + Physical Therapy | Sham tDCS + Physical Therapy + Occupational Therapy | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 3 Participants | 2 Participants | 7 Participants |
| Age, Continuous | 55.3 years STANDARD_DEVIATION 15.2 | 53.33 years STANDARD_DEVIATION 4.02 | 54.0 years STANDARD_DEVIATION 8.52 | 54.22 years STANDARD_DEVIATION 10.97 |
| Hemisphere lesioned Left hemisphere | 3 Participants | 2 Participants | 2 Participants | 7 Participants |
| Hemisphere lesioned Right hemisphere | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Hospital Anxiety and Depression Scale | 8 units on a scale | 6 units on a scale | 8 units on a scale | 8 units on a scale |
| Manual dominance Left | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Manual dominance Right | 3 Participants | 2 Participants | 3 Participants | 8 Participants |
| Mini Mental State Exam | 20 units on a scale | 27 units on a scale | 25 units on a scale | 25 units on a scale |
| Modified Rankin Scale | 3 units on a scale | 3 units on a scale | 3 units on a scale | 3 units on a scale |
| National Institutes of Health Stroke Scale | 6 units on a scale | 6 units on a scale | 3 units on a scale | 4 units on a scale |
| Race/Ethnicity, Customized Ethnicity Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Ethnicity Back | 2 Participants | 2 Participants | 3 Participants | 7 Participants |
| Race/Ethnicity, Customized Ethnicity White | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 2 Participants | 7 Participants |
| Time since stroke | 49.3 days STANDARD_DEVIATION 11.1 | 40.0 days STANDARD_DEVIATION 16.75 | 36.66 days STANDARD_DEVIATION 11.11 | 41.56 days STANDARD_DEVIATION 15.21 |
| Upper Extremity Fugl Meyer Assessment | 19.3 units on a scale STANDARD_DEVIATION 9.8 | 17.7 units on a scale STANDARD_DEVIATION 4.2 | 21.7 units on a scale STANDARD_DEVIATION 7.8 | 18.89 units on a scale STANDARD_DEVIATION 6.27 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 3 | 0 / 3 |
| other Total, other adverse events | 3 / 3 | 3 / 3 | 2 / 3 |
| serious Total, serious adverse events | 0 / 3 | 0 / 3 | 0 / 3 |
Outcome results
Primary
Change in Upper Extremity Fugl Meyer Assessment
Change in Motor function subscale was assessed. Scores range from 0 to 66. Lower scores indicate greater severity.
Time frame: 6 weeks from baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active tDCS + Robotic Therapy + Physical Therapy | Change in Upper Extremity Fugl Meyer Assessment | 10.6 score on a scale | Standard Deviation 7.3 |
| Sham tDCS + Robotic Therapy + Physical Therapy | Change in Upper Extremity Fugl Meyer Assessment | 12.3 score on a scale | Standard Deviation 11.4 |
| Sham tDCS + Physical Therapy + Occupational Therapy | Change in Upper Extremity Fugl Meyer Assessment | 22.3 score on a scale | Standard Deviation 12.4 |
Primary
Percentage of Sessions With Adverse Events
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Active tDCS + Robotic Therapy + Physical Therapy | Percentage of Sessions With Adverse Events | Itching reported during tDCS | 5.6 percentage of sessions |
| Active tDCS + Robotic Therapy + Physical Therapy | Percentage of Sessions With Adverse Events | Dysesthesia reported during PT | 0 percentage of sessions |
| Active tDCS + Robotic Therapy + Physical Therapy | Percentage of Sessions With Adverse Events | Dysesthesia reported during RT or OT | 1.8 percentage of sessions |
| Active tDCS + Robotic Therapy + Physical Therapy | Percentage of Sessions With Adverse Events | Pain reported during RT or OT | 5.7 percentage of sessions |
| Active tDCS + Robotic Therapy + Physical Therapy | Percentage of Sessions With Adverse Events | Seizure reported during PT | 0 percentage of sessions |
| Active tDCS + Robotic Therapy + Physical Therapy | Percentage of Sessions With Adverse Events | Sleepiness reported during RT or OT | 9.4 percentage of sessions |
| Active tDCS + Robotic Therapy + Physical Therapy | Percentage of Sessions With Adverse Events | Fatigue reported during RT or OT | 18.9 percentage of sessions |
| Active tDCS + Robotic Therapy + Physical Therapy | Percentage of Sessions With Adverse Events | Burning reported during tDCS | 0 percentage of sessions |
| Active tDCS + Robotic Therapy + Physical Therapy | Percentage of Sessions With Adverse Events | Seizure reported during RT or OT | 0 percentage of sessions |
| Active tDCS + Robotic Therapy + Physical Therapy | Percentage of Sessions With Adverse Events | Dizziness reported during RT or OT | 0 percentage of sessions |
| Active tDCS + Robotic Therapy + Physical Therapy | Percentage of Sessions With Adverse Events | Fatigue reported during tDCS | 0 percentage of sessions |
| Active tDCS + Robotic Therapy + Physical Therapy | Percentage of Sessions With Adverse Events | Syncope reported during RT or OT | 0 percentage of sessions |
| Active tDCS + Robotic Therapy + Physical Therapy | Percentage of Sessions With Adverse Events | Syncope reported during FT | 0 percentage of sessions |
| Active tDCS + Robotic Therapy + Physical Therapy | Percentage of Sessions With Adverse Events | Hot reported during tDCS | 0 percentage of sessions |
| Active tDCS + Robotic Therapy + Physical Therapy | Percentage of Sessions With Adverse Events | Pain reported during tDCS | 0 percentage of sessions |
| Active tDCS + Robotic Therapy + Physical Therapy | Percentage of Sessions With Adverse Events | Dizziness reported during PT | 0 percentage of sessions |
| Active tDCS + Robotic Therapy + Physical Therapy | Percentage of Sessions With Adverse Events | Pinching reported during tDCS | 9.4 percentage of sessions |
| Active tDCS + Robotic Therapy + Physical Therapy | Percentage of Sessions With Adverse Events | Sleepiness reported during PT | 1.8 percentage of sessions |
| Active tDCS + Robotic Therapy + Physical Therapy | Percentage of Sessions With Adverse Events | Fatigue reported during PT | 3.8 percentage of sessions |
| Active tDCS + Robotic Therapy + Physical Therapy | Percentage of Sessions With Adverse Events | Metallic taste reported during tDCS | 0 percentage of sessions |
| Active tDCS + Robotic Therapy + Physical Therapy | Percentage of Sessions With Adverse Events | Tingling reported during tDCS | 100 percentage of sessions |
| Active tDCS + Robotic Therapy + Physical Therapy | Percentage of Sessions With Adverse Events | Pain reported during PT | 11.3 percentage of sessions |
| Sham tDCS + Robotic Therapy + Physical Therapy | Percentage of Sessions With Adverse Events | Sleepiness reported during RT or OT | 6.4 percentage of sessions |
| Sham tDCS + Robotic Therapy + Physical Therapy | Percentage of Sessions With Adverse Events | Pain reported during tDCS | 0 percentage of sessions |
| Sham tDCS + Robotic Therapy + Physical Therapy | Percentage of Sessions With Adverse Events | Fatigue reported during tDCS | 0 percentage of sessions |
| Sham tDCS + Robotic Therapy + Physical Therapy | Percentage of Sessions With Adverse Events | Tingling reported during tDCS | 27.7 percentage of sessions |
| Sham tDCS + Robotic Therapy + Physical Therapy | Percentage of Sessions With Adverse Events | Burning reported during tDCS | 2.1 percentage of sessions |
| Sham tDCS + Robotic Therapy + Physical Therapy | Percentage of Sessions With Adverse Events | Hot reported during tDCS | 0 percentage of sessions |
| Sham tDCS + Robotic Therapy + Physical Therapy | Percentage of Sessions With Adverse Events | Pinching reported during tDCS | 31.9 percentage of sessions |
| Sham tDCS + Robotic Therapy + Physical Therapy | Percentage of Sessions With Adverse Events | Metallic taste reported during tDCS | 0 percentage of sessions |
| Sham tDCS + Robotic Therapy + Physical Therapy | Percentage of Sessions With Adverse Events | Itching reported during tDCS | 2.1 percentage of sessions |
| Sham tDCS + Robotic Therapy + Physical Therapy | Percentage of Sessions With Adverse Events | Pain reported during RT or OT | 24.3 percentage of sessions |
| Sham tDCS + Robotic Therapy + Physical Therapy | Percentage of Sessions With Adverse Events | Fatigue reported during RT or OT | 14 percentage of sessions |
| Sham tDCS + Robotic Therapy + Physical Therapy | Percentage of Sessions With Adverse Events | Dizziness reported during RT or OT | 0 percentage of sessions |
| Sham tDCS + Robotic Therapy + Physical Therapy | Percentage of Sessions With Adverse Events | Syncope reported during RT or OT | 0 percentage of sessions |
| Sham tDCS + Robotic Therapy + Physical Therapy | Percentage of Sessions With Adverse Events | Seizure reported during RT or OT | 0 percentage of sessions |
| Sham tDCS + Robotic Therapy + Physical Therapy | Percentage of Sessions With Adverse Events | Dysesthesia reported during RT or OT | 0 percentage of sessions |
| Sham tDCS + Robotic Therapy + Physical Therapy | Percentage of Sessions With Adverse Events | Pain reported during PT | 23.4 percentage of sessions |
| Sham tDCS + Robotic Therapy + Physical Therapy | Percentage of Sessions With Adverse Events | Fatigue reported during PT | 17 percentage of sessions |
| Sham tDCS + Robotic Therapy + Physical Therapy | Percentage of Sessions With Adverse Events | Dizziness reported during PT | 0 percentage of sessions |
| Sham tDCS + Robotic Therapy + Physical Therapy | Percentage of Sessions With Adverse Events | Syncope reported during FT | 0 percentage of sessions |
| Sham tDCS + Robotic Therapy + Physical Therapy | Percentage of Sessions With Adverse Events | Seizure reported during PT | 0 percentage of sessions |
| Sham tDCS + Robotic Therapy + Physical Therapy | Percentage of Sessions With Adverse Events | Sleepiness reported during PT | 6.4 percentage of sessions |
| Sham tDCS + Robotic Therapy + Physical Therapy | Percentage of Sessions With Adverse Events | Dysesthesia reported during PT | 0 percentage of sessions |
| Sham tDCS + Physical Therapy + Occupational Therapy | Percentage of Sessions With Adverse Events | Pain reported during tDCS | 1.9 percentage of sessions |
| Sham tDCS + Physical Therapy + Occupational Therapy | Percentage of Sessions With Adverse Events | Dysesthesia reported during RT or OT | 0 percentage of sessions |
| Sham tDCS + Physical Therapy + Occupational Therapy | Percentage of Sessions With Adverse Events | Metallic taste reported during tDCS | 0 percentage of sessions |
| Sham tDCS + Physical Therapy + Occupational Therapy | Percentage of Sessions With Adverse Events | Seizure reported during PT | 0 percentage of sessions |
| Sham tDCS + Physical Therapy + Occupational Therapy | Percentage of Sessions With Adverse Events | Pain reported during PT | 24.5 percentage of sessions |
| Sham tDCS + Physical Therapy + Occupational Therapy | Percentage of Sessions With Adverse Events | Pinching reported during tDCS | 30.2 percentage of sessions |
| Sham tDCS + Physical Therapy + Occupational Therapy | Percentage of Sessions With Adverse Events | Fatigue reported during tDCS | 0 percentage of sessions |
| Sham tDCS + Physical Therapy + Occupational Therapy | Percentage of Sessions With Adverse Events | Hot reported during tDCS | 0 percentage of sessions |
| Sham tDCS + Physical Therapy + Occupational Therapy | Percentage of Sessions With Adverse Events | Dysesthesia reported during PT | 0 percentage of sessions |
| Sham tDCS + Physical Therapy + Occupational Therapy | Percentage of Sessions With Adverse Events | Dizziness reported during PT | 0 percentage of sessions |
| Sham tDCS + Physical Therapy + Occupational Therapy | Percentage of Sessions With Adverse Events | Burning reported during tDCS | 5.7 percentage of sessions |
| Sham tDCS + Physical Therapy + Occupational Therapy | Percentage of Sessions With Adverse Events | Sleepiness reported during PT | 5.7 percentage of sessions |
| Sham tDCS + Physical Therapy + Occupational Therapy | Percentage of Sessions With Adverse Events | Dizziness reported during RT or OT | 0 percentage of sessions |
| Sham tDCS + Physical Therapy + Occupational Therapy | Percentage of Sessions With Adverse Events | Syncope reported during FT | 0 percentage of sessions |
| Sham tDCS + Physical Therapy + Occupational Therapy | Percentage of Sessions With Adverse Events | Syncope reported during RT or OT | 0 percentage of sessions |
| Sham tDCS + Physical Therapy + Occupational Therapy | Percentage of Sessions With Adverse Events | Fatigue reported during RT or OT | 17 percentage of sessions |
| Sham tDCS + Physical Therapy + Occupational Therapy | Percentage of Sessions With Adverse Events | Tingling reported during tDCS | 37.7 percentage of sessions |
| Sham tDCS + Physical Therapy + Occupational Therapy | Percentage of Sessions With Adverse Events | Seizure reported during RT or OT | 0 percentage of sessions |
| Sham tDCS + Physical Therapy + Occupational Therapy | Percentage of Sessions With Adverse Events | Pain reported during RT or OT | 7.5 percentage of sessions |
| Sham tDCS + Physical Therapy + Occupational Therapy | Percentage of Sessions With Adverse Events | Fatigue reported during PT | 0 percentage of sessions |
| Sham tDCS + Physical Therapy + Occupational Therapy | Percentage of Sessions With Adverse Events | Sleepiness reported during RT or OT | 5.7 percentage of sessions |
| Sham tDCS + Physical Therapy + Occupational Therapy | Percentage of Sessions With Adverse Events | Itching reported during tDCS | 5.7 percentage of sessions |
Secondary
Change in Fatigue Severity Scale
Fatigue 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.
Time frame: 6 weeks from baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active tDCS + Robotic Therapy + Physical Therapy | Change in Fatigue Severity Scale | 1.7 score on a scale | Standard Deviation 11.4 |
| Sham tDCS + Robotic Therapy + Physical Therapy | Change in Fatigue Severity Scale | -1.7 score on a scale | Standard Deviation 16.3 |
| Sham tDCS + Physical Therapy + Occupational Therapy | Change in Fatigue Severity Scale | -30.7 score on a scale | Standard Deviation 13.7 |
Secondary
Change in Modified Rankin Scale
Scores range from 0 to 6. Higher scores indicate greater severity.
Time frame: 6 weeks from baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Active tDCS + Robotic Therapy + Physical Therapy | Change in Modified Rankin Scale | 0 score on a scale |
| Sham tDCS + Robotic Therapy + Physical Therapy | Change in Modified Rankin Scale | 0 score on a scale |
| Sham tDCS + Physical Therapy + Occupational Therapy | Change in Modified Rankin Scale | -1 score on a scale |
Secondary
Change in Motor Activity Log
Each domain contains taks scored on 0 to 5 ordinal scale. Lower scores indicate greater severity.
Time frame: 6 weeks from baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active tDCS + Robotic Therapy + Physical Therapy | Change in Motor Activity Log | Amount of Movement | 0.6 score on a scale | Standard Deviation 0.4 |
| Active tDCS + Robotic Therapy + Physical Therapy | Change in Motor Activity Log | Quality of Movement | 0.6 score on a scale | Standard Deviation 0.4 |
| Sham tDCS + Robotic Therapy + Physical Therapy | Change in Motor Activity Log | Amount of Movement | 0.4 score on a scale | Standard Deviation 0.4 |
| Sham tDCS + Robotic Therapy + Physical Therapy | Change in Motor Activity Log | Quality of Movement | 0.5 score on a scale | Standard Deviation 0.6 |
| Sham tDCS + Physical Therapy + Occupational Therapy | Change in Motor Activity Log | Amount of Movement | 0.6 score on a scale | Standard Deviation 0.2 |
| Sham tDCS + Physical Therapy + Occupational Therapy | Change in Motor Activity Log | Quality of Movement | 0.8 score on a scale | Standard Deviation 0.5 |
Secondary
Change in National Institutes of Health Stroke Scale
Scores range from 0 to 42. Higher scores indicate greater severity.
Time frame: 6 weeks from baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Active tDCS + Robotic Therapy + Physical Therapy | Change in National Institutes of Health Stroke Scale | -3 score on a scale |
| Sham tDCS + Robotic Therapy + Physical Therapy | Change in National Institutes of Health Stroke Scale | -1 score on a scale |
| Sham tDCS + Physical Therapy + Occupational Therapy | Change in National Institutes of Health Stroke Scale | -2 score on a scale |
Secondary
Change in Pittsburgh Sleep Quality Index
The 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.
Time frame: 6 weeks from baseline
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Active tDCS + Robotic Therapy + Physical Therapy | Change in Pittsburgh Sleep Quality Index | -1.0 score on a scale | Standard Deviation 1 |
| Sham tDCS + Robotic Therapy + Physical Therapy | Change in Pittsburgh Sleep Quality Index | -2.3 score on a scale | Standard Deviation 2.5 |
| Sham tDCS + Physical Therapy + Occupational Therapy | Change in Pittsburgh Sleep Quality Index | 0.3 score on a scale | Standard Deviation 3.1 |
Secondary
Change in Stroke Impact Scale
Scores 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.
Time frame: 6 weeks from baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active tDCS + Robotic Therapy + Physical Therapy | Change in Stroke Impact Scale | Strength | 14.6 score on a scale | Standard Deviation 7.7 |
| Active tDCS + Robotic Therapy + Physical Therapy | Change in Stroke Impact Scale | Memory | 11.9 score on a scale | Standard Deviation 4.4 |
| Active tDCS + Robotic Therapy + Physical Therapy | Change in Stroke Impact Scale | Emotions | 9.2 score on a scale | Standard Deviation 13.6 |
| Active tDCS + Robotic Therapy + Physical Therapy | Change in Stroke Impact Scale | Comunication | 2.3 score on a scale | Standard Deviation 6.7 |
| Active tDCS + Robotic Therapy + Physical Therapy | Change in Stroke Impact Scale | Activities of daily living | 14.1 score on a scale | Standard Deviation 22.4 |
| Active tDCS + Robotic Therapy + Physical Therapy | Change in Stroke Impact Scale | Mobility | 24.1 score on a scale | Standard Deviation 30.4 |
| Active tDCS + Robotic Therapy + Physical Therapy | Change in Stroke Impact Scale | HandFunction | 15.0 score on a scale | Standard Deviation 12.2 |
| Active tDCS + Robotic Therapy + Physical Therapy | Change in Stroke Impact Scale | Participation | 10.4 score on a scale | Standard Deviation 34.7 |
| Sham tDCS + Robotic Therapy + Physical Therapy | Change in Stroke Impact Scale | Emotions | 5.5 score on a scale | Standard Deviation 3.1 |
| Sham tDCS + Robotic Therapy + Physical Therapy | Change in Stroke Impact Scale | HandFunction | 36.7 score on a scale | Standard Deviation 0.3 |
| Sham tDCS + Robotic Therapy + Physical Therapy | Change in Stroke Impact Scale | Comunication | 6.0 score on a scale | Standard Deviation 1.7 |
| Sham tDCS + Robotic Therapy + Physical Therapy | Change in Stroke Impact Scale | Activities of daily living | 25.8 score on a scale | Standard Deviation 10 |
| Sham tDCS + Robotic Therapy + Physical Therapy | Change in Stroke Impact Scale | Mobility | 15.8 score on a scale | Standard Deviation 1 |
| Sham tDCS + Robotic Therapy + Physical Therapy | Change in Stroke Impact Scale | Strength | 16.7 score on a scale | Standard Deviation 7.8 |
| Sham tDCS + Robotic Therapy + Physical Therapy | Change in Stroke Impact Scale | Memory | 14.3 score on a scale | Standard Deviation 10.4 |
| Sham tDCS + Robotic Therapy + Physical Therapy | Change in Stroke Impact Scale | Participation | 15.6 score on a scale | Standard Deviation 6.6 |
| Sham tDCS + Physical Therapy + Occupational Therapy | Change in Stroke Impact Scale | Emotions | 3.7 score on a scale | Standard Deviation 1.5 |
| Sham tDCS + Physical Therapy + Occupational Therapy | Change in Stroke Impact Scale | Memory | -1.2 score on a scale | Standard Deviation 3.6 |
| Sham tDCS + Physical Therapy + Occupational Therapy | Change in Stroke Impact Scale | Strength | 10.4 score on a scale | Standard Deviation 7.7 |
| Sham tDCS + Physical Therapy + Occupational Therapy | Change in Stroke Impact Scale | Comunication | 3.6 score on a scale | Standard Deviation 4.4 |
| Sham tDCS + Physical Therapy + Occupational Therapy | Change in Stroke Impact Scale | HandFunction | 46.6 score on a scale | Standard Deviation 17.8 |
| Sham tDCS + Physical Therapy + Occupational Therapy | Change in Stroke Impact Scale | Mobility | 20.4 score on a scale | Standard Deviation 2.5 |
| Sham tDCS + Physical Therapy + Occupational Therapy | Change in Stroke Impact Scale | Activities of daily living | 20.0 score on a scale | Standard Deviation 7.8 |
| Sham tDCS + Physical Therapy + Occupational Therapy | Change in Stroke Impact Scale | Participation | -6.2 score on a scale | Standard Deviation 6.2 |
Secondary
Number of Participants Who Presented Score on Modified Ashworth Scale >2
Scores range from 0 to 4, with 5 choices. A score of 1 indicates no resistance, and 4 indicates rigidity.
Time frame: 6 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active tDCS + Robotic Therapy + Physical Therapy | Number of Participants Who Presented Score on Modified Ashworth Scale >2 | 0 participants |
| Sham tDCS + Robotic Therapy + Physical Therapy | Number of Participants Who Presented Score on Modified Ashworth Scale >2 | 0 participants |
| Sham tDCS + Physical Therapy + Occupational Therapy | Number of Participants Who Presented Score on Modified Ashworth Scale >2 | 0 participants |
Secondary
Number of Participants With Adverse Events
Time frame: 6 months follow-up
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Active tDCS + Robotic Therapy + Physical Therapy | Number of Participants With Adverse Events | headache | 0 participants |
| Active tDCS + Robotic Therapy + Physical Therapy | Number of Participants With Adverse Events | pain on shoulder mobilization | 1 participants |
| Active tDCS + Robotic Therapy + Physical Therapy | Number of Participants With Adverse Events | dizziness | 0 participants |
| Active tDCS + Robotic Therapy + Physical Therapy | Number of Participants With Adverse Events | syncope | 0 participants |
| Active tDCS + Robotic Therapy + Physical Therapy | Number of Participants With Adverse Events | seizures | 0 participants |
| Active tDCS + Robotic Therapy + Physical Therapy | Number of Participants With Adverse Events | dysesthesia | 0 participants |
| Active tDCS + Robotic Therapy + Physical Therapy | Number of Participants With Adverse Events | psychiatric disorder | 0 participants |
| Active tDCS + Robotic Therapy + Physical Therapy | Number of Participants With Adverse Events | sleep | 0 participants |
| Sham tDCS + Robotic Therapy + Physical Therapy | Number of Participants With Adverse Events | dizziness | 0 participants |
| Sham tDCS + Robotic Therapy + Physical Therapy | Number of Participants With Adverse Events | psychiatric disorder | 0 participants |
| Sham tDCS + Robotic Therapy + Physical Therapy | Number of Participants With Adverse Events | syncope | 0 participants |
| Sham tDCS + Robotic Therapy + Physical Therapy | Number of Participants With Adverse Events | seizures | 0 participants |
| Sham tDCS + Robotic Therapy + Physical Therapy | Number of Participants With Adverse Events | dysesthesia | 0 participants |
| Sham tDCS + Robotic Therapy + Physical Therapy | Number of Participants With Adverse Events | headache | 0 participants |
| Sham tDCS + Robotic Therapy + Physical Therapy | Number of Participants With Adverse Events | pain on shoulder mobilization | 2 participants |
| Sham tDCS + Robotic Therapy + Physical Therapy | Number of Participants With Adverse Events | sleep | 1 participants |
| Sham tDCS + Physical Therapy + Occupational Therapy | Number of Participants With Adverse Events | dizziness | 0 participants |
| Sham tDCS + Physical Therapy + Occupational Therapy | Number of Participants With Adverse Events | pain on shoulder mobilization | 1 participants |
| Sham tDCS + Physical Therapy + Occupational Therapy | Number of Participants With Adverse Events | headache | 0 participants |
| Sham tDCS + Physical Therapy + Occupational Therapy | Number of Participants With Adverse Events | syncope | 0 participants |
| Sham tDCS + Physical Therapy + Occupational Therapy | Number of Participants With Adverse Events | psychiatric disorder | 0 participants |
| Sham tDCS + Physical Therapy + Occupational Therapy | Number of Participants With Adverse Events | dysesthesia | 0 participants |
| Sham tDCS + Physical Therapy + Occupational Therapy | Number of Participants With Adverse Events | seizures | 0 participants |
| Sham tDCS + Physical Therapy + Occupational Therapy | Number of Participants With Adverse Events | sleep | 0 participants |
Secondary
Upper Extremity Fugl Meyer Assessment
Motor function subscale was assessed. Scores range from 0 to 66. Lower scores indicate greater severity.
Time frame: 6 months follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active tDCS + Robotic Therapy + Physical Therapy | Upper Extremity Fugl Meyer Assessment | 42 score on a scale | Standard Deviation 13 |
| Sham tDCS + Robotic Therapy + Physical Therapy | Upper Extremity Fugl Meyer Assessment | 34 score on a scale | Standard Deviation 14.9 |
| Sham tDCS + Physical Therapy + Occupational Therapy | Upper Extremity Fugl Meyer Assessment | 44.5 score on a scale | Standard Deviation 15.5 |