StrokeROTSNCT02416791
Robotic Therapy and Transcranial Direct Current Stimulation in Patients With Stroke
A study testing Robotic Therapy, Active tDCS and Physical Therapy in people with Stroke, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Robotic Therapy, Active tDCS and Physical Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Robotic Therapy, Active tDCS, Sham tDCS, Physical Therapy, Occupational Therapy
- Keywords
- robotic therapy, transcranial direct current stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic TherapyDevice
Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.
Active tDCSDevice
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 tDCSDevice
In sham tDCS, no current will be delivered through the tDCS device.
Physical TherapyOther
Physical therapy will be administered for 40 minutes.
Occupational TherapyOther
Occupational therapy will be administered for 40 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Robotic Therapy; Device: Active tDCS; Other: Physical Therapy |
| 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). Receives: Device: Robotic Therapy; Device: Sham tDCS; Other: Physical Therapy |
| 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). Receives: Device: Sham tDCS; Other: Physical Therapy; Other: Occupational Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks from baseline
Percentage of Sessions With Adverse Events
Measured: Post treatment (6 weeks from baseline).
Secondary outcomes (9)
Change in Modified Rankin Scale
Scores range from 0 to 6. Higher scores indicate greater severity.
Measured: 6 weeks from baseline
Change in National Institutes of Health Stroke Scale
Scores range from 0 to 42. Higher scores indicate greater severity.
Measured: 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.
Measured: 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.
Measured: 6 weeks
Change in Motor Activity Log
Each domain contains taks scored on 0 to 5 ordinal scale. Lower scores indicate greater severity.
Measured: 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.
Measured: 6 months follow-up
Number of Participants With Adverse Events
Measured: 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.
Measured: 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.
Measured: 6 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: Because of low recruitment rates
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Sponsor
- Investigators
- Adriana B Conforto, MD Phd, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02416791
- Sponsor's protocol ID
- 513.207
- Acronym
- ROTS
- Status last verified
- Dec 2015
- First submitted
- 20 Feb 2015
- Last updated
- 20 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 33175411
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Therapy and Transcranial Direct Current Stimulation in Patients With Stroke
- ClinicalTrials.gov ID
- NCT02416791
- Acronym / sponsor ID
- ROTS / 513.207
- Conditions
- Stroke
- Keywords
- robotic therapy, transcranial direct current stimulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Because of low recruitment rates
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Jun 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 15 Apr 2015 (estimated)
- Results
- Posted 20 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active tDCS + robotic therapy + physical therapy | Active comparator | Device: Robotic Therapy, Device: Active tDCS, Other: Physical TherapyActive 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 | Device: Robotic Therapy, Device: Sham tDCS, Other: Physical TherapySham 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 | Device: Sham tDCS, Other: Physical Therapy, Other: Occupational TherapySham 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic TherapyRobotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb. | Device | Active tDCS + robotic therapy + physical therapy, sham tDCS + robotic therapy + physical therapy |
| Active tDCSActive 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). | Device | Active tDCS + robotic therapy + physical therapy |
| Sham tDCSIn sham tDCS, no current will be delivered through the tDCS device. | Device | sham tDCS + physical therapy + occupational therapy, sham tDCS + robotic therapy + physical therapy |
| Physical TherapyPhysical therapy will be administered for 40 minutes. | Other | Active tDCS + robotic therapy + physical therapy, sham tDCS + physical therapy + occupational therapy, sham tDCS + robotic therapy + physical therapy |
| Occupational TherapyOccupational therapy will be administered for 40 minutes. | Other | sham tDCS + physical therapy + occupational therapy |
Primary outcome
Change in Upper Extremity Fugl Meyer Assessment
Time frame: 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
Time frame: Post treatment (6 weeks from baseline).
9 secondary outcomes
Change in Modified Rankin Scale
Time frame: 6 weeks from baseline
Change in National Institutes of Health Stroke Scale
Time frame: 6 weeks from baseline
Change in Stroke Impact Scale
Time frame: 6 weeks from baseline
Number of Participants Who Presented Score on Modified Ashworth Scale >2
Time frame: 6 weeks
Change in Motor Activity Log
Time frame: 6 weeks from baseline
Upper Extremity Fugl Meyer Assessment
Time frame: 6 months follow-up
Number of Participants With Adverse Events
Time frame: 6 months follow-up
Change in Fatigue Severity Scale
Time frame: 6 weeks from baseline
Change in Pittsburgh Sleep Quality Index
Time frame: 6 weeks from baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33175411Elsner 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.
Related trials for Stroke
Active, not recruitingObservational study
Symptomatic Carotid Outcomes Registry
Carotid Stenosis, Ischemic Stroke
RecruitingPhase 3
Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
Atrial Fibrillation (AF)
Not yet recruiting
The Effects of an Augmented Reality-Based Mirror Therapy System in Patients With Stroke
Stroke
Recruiting
A Pivotal Study Evaluating Safety and Effectiveness of Adaptative Tip Catheter in Patients With Acute Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
Role of EEG in Differentiation Between Ischemic and Hemorrhagic Stroke
Acute Ischemic Stroke, Acute Haemorrhagic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adriana B Conforto, MD Phd principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic Therapy, Active tDCS and Physical Therapy in people with Stroke, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Upper Extremity Fugl Meyer Assessment (time frame: 6 weeks from baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02416791, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2020.