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Because of low recruitment rates
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| Name | Class |
|---|---|
| Conselho Nacional de Desenvolvimento Científico e Tecnológico | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tDCS + robotic therapy + physical therapy | Active Comparator | 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). |
|
| sham tDCS + robotic therapy + physical therapy | Active Comparator | 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). |
|
| sham tDCS + physical therapy + occupational therapy | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic Therapy | Device | Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks from baseline |
| Percentage of Sessions With Adverse Events | Post treatment (6 weeks from baseline). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Modified Rankin Scale | Scores range from 0 to 6. Higher scores indicate greater severity. | 6 weeks from baseline |
| Change in National Institutes of Health Stroke Scale | Scores range from 0 to 42. Higher scores indicate greater severity. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adriana B Conforto, MD Phd | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das Clínicas | São Paulo | São Paulo | 05403900 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33175411 | Derived | Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6 Weeks |
| |||||||||||||
| 6 Months |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks from baseline |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tingling | Skin and subcutaneous tissue disorders | Systematic Assessment | Tolerability to tDCS intervention |
The study was stopped earlier due to low recruitment rates. We consider psychosocial aspects and poor family support as an important factor to these low rates. The small sample size (9 patients) does not allow conclusions with statistical relevance.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Adriana Bastos Conforto | Neurostimulation Laboratory, Hospital das Clínicas/São Paulo University, Brazil | +55 11 2661-7955 | adriana.conforto@hc.fm.usp.br |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| D009788 | Occupational Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| Active tDCS | Device | 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). |
|
| Sham tDCS | Device | In sham tDCS, no current will be delivered through the tDCS device. |
|
| Physical Therapy | Other | Physical therapy will be administered for 40 minutes. |
|
| Occupational Therapy | Other | Occupational therapy will be administered for 40 minutes. |
|
| 6 weeks from baseline |
| 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. | 6 weeks from baseline |
| 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. | 6 weeks |
| Change in Motor Activity Log | Each domain contains taks scored on 0 to 5 ordinal scale. Lower scores indicate greater severity. | 6 weeks from baseline |
| Upper Extremity Fugl Meyer Assessment | Motor function subscale was assessed. Scores range from 0 to 66. Lower scores indicate greater severity. | 6 months follow-up |
| Number of Participants With Adverse Events | 6 months follow-up |
| 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. | 6 weeks from baseline |
| 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. | 6 weeks from baseline |
| NOT COMPLETED |
|
|
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Time since stroke | Mean | Standard Deviation | days |
|
| Manual dominance | Count of Participants | Participants |
|
| Hemisphere lesioned | Count of Participants | Participants |
|
| Upper Extremity Fugl Meyer Assessment | Motor function subscale was assessed. Scores range from 0 - 66. Lower scores indicate greater severity. | Mean | Standard Deviation | units on a scale |
|
| Mini Mental State Exam | Scores range from 0 to 30. Lower scores indicate greater severity. | Median | Full Range | units on a scale |
|
| National Institutes of Health Stroke Scale | Scores range from 0 -42. Higher scores indicate greater severity. | Median | Full Range | units on a scale |
|
| Modified Rankin Scale | Scores range from 0 to 6. Higher scores indicate greater severity. | Median | Full Range | units on a scale |
|
| Hospital Anxiety and Depression Scale | Both subscales (Anxiety and Depression subscales) were assessed. Scores range from 0 to 42. Higher scores indicate greater severity. | Median | Full Range | units on a scale |
|
| OG001 | 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. |
| OG002 | 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. |
|
|
| Primary | Percentage of Sessions With Adverse Events | 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. | Posted | Number | percentage of sessions | Post treatment (6 weeks from baseline). | Number of sessions | Number of sessions |
|
|
|
| Secondary | Change in Modified Rankin Scale | Scores range from 0 to 6. Higher scores indicate greater severity. | Posted | Median | Full Range | score on a scale | 6 weeks from baseline |
|
|
|
| Secondary | Change in National Institutes of Health Stroke Scale | Scores range from 0 to 42. Higher scores indicate greater severity. | Posted | Median | Full Range | score on a scale | 6 weeks from baseline |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks from baseline |
|
|
|
| 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. | Posted | Number | participants | 6 weeks |
|
|
|
| Secondary | Change in Motor Activity Log | Each domain contains taks scored on 0 to 5 ordinal scale. Lower scores indicate greater severity. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks from baseline |
|
|
|
| Secondary | Upper Extremity Fugl Meyer Assessment | Motor function subscale was assessed. Scores range from 0 to 66. Lower scores indicate greater severity. | Posted | Mean | Standard Deviation | score on a scale | 6 months follow-up |
|
|
|
| Secondary | Number of Participants With Adverse Events | Posted | Number | participants | 6 months follow-up |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks from baseline |
|
|
|
| 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. | Posted | Median | Standard Deviation | score on a scale | 6 weeks from baseline |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 3 |
| 3 |
| EG001 | 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. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG002 | 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. | 0 | 3 | 0 | 3 | 2 | 3 |
|
| Pinching | Skin and subcutaneous tissue disorders | Systematic Assessment | Tolerability to tDCS intervention |
|
| Fatigue | Musculoskeletal and connective tissue disorders | Systematic Assessment | Tolerability to motor interventions (Robotic Therapy or Occupational Therapy) |
|
| Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Tolerability to motor interventions (Robotic Therapy or Occupational Therapy) |
|
| Sleepiness | Nervous system disorders | Systematic Assessment | Tolerability to motor interventions (Robotic Therapy or Occupational Therapy) |
|
| Fatigue | Musculoskeletal and connective tissue disorders | Systematic Assessment | Tolerability to Physical Therapy interventions |
|
| Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Tolerability to Physical Therapy interventions |
|
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D005791 |
| Patient Care |
|
| Tingling reported during tDCS |
|
| Burning reported during tDCS |
|
| Hot reported during tDCS |
|
| Pinching reported during tDCS |
|
| Metallic taste reported during tDCS |
|
| Itching reported during tDCS |
|
| Pain reported during RT or OT |
|
| Fatigue reported during RT or OT |
|
| Dizziness reported during RT or OT |
|
| Syncope reported during RT or OT |
|
| Seizure reported during RT or OT |
|
| Sleepiness reported during RT or OT |
|
| Dysesthesia reported during RT or OT |
|
| Pain reported during PT |
|
| Fatigue reported during PT |
|
| Dizziness reported during PT |
|
| Syncope reported during FT |
|
| Seizure reported during PT |
|
| Sleepiness reported during PT |
|
| Dysesthesia reported during PT |
|
|
| Emotions |
|
| Comunication |
|
| Activities of daily living |
|
| Mobility |
|
| HandFunction |
|
| Participation |
|
|
| Title | Measurements |
|---|---|
|
| dizziness |
|
| syncope |
|
| seizures |
|
| dysesthesia |
|
| psychiatric disorder |
|
| sleep |
|