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Robotic Therapy and Transcranial Direct Current Stimulation in Patients With Stroke (ROTS)

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ClinicalTrials.gov Identifier: NCT02416791
Recruitment Status : Terminated (Because of low recruitment rates)
First Posted : April 15, 2015
Last Update Posted : May 17, 2017
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

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.

Condition or disease Intervention/treatment Phase
Stroke Device: Robotic Therapy Device: Active tDCS Device: Sham tDCS Other: Physical Therapy Other: Occupational Therapy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Robotic Therapy and Transcranial Direct Current Stimulation in Patients With Stroke
Study Start Date : June 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Arm Intervention/treatment
Active Comparator: 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).

Device: Robotic Therapy
Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.

Device: 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).

Other: Physical Therapy
Physical therapy will be administered for 40 minutes.

Active Comparator: 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).

Device: Robotic Therapy
Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.

Device: Sham tDCS
In sham tDCS, no current will be delivered through the tDCS device.

Other: Physical Therapy
Physical therapy will be administered for 40 minutes.

Experimental: 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).
Device: Sham tDCS
In sham tDCS, no current will be delivered through the tDCS device.

Other: Physical Therapy
Physical therapy will be administered for 40 minutes.

Other: Occupational Therapy
Occupational therapy will be administered for 40 minutes.




Primary Outcome Measures :
  1. Upper limb subscale of Fugl Meyer Assessment of Sensorimotor recovery after stroke [ Time Frame: Change post treatment (6 weeks from baseline) compared to baseline ]
  2. Adverse events [ Time Frame: Change post treatment (6 weeks from baseline) compared to baseline ]

Secondary Outcome Measures :
  1. Modified Rankin Scale [ Time Frame: Change post treatment (6 weeks from baseline) compared to baseline ]
  2. NIH Stroke Scale [ Time Frame: Change post treatment (6 weeks from baseline) compared to baseline ]
  3. Stroke Impact Scale [ Time Frame: Change post treatment (6 weeks from baseline) compared to baseline ]
  4. Modified Ashworth Scale [ Time Frame: Change post treatment (6 weeks from baseline) compared to baseline ]
  5. Motor Activity Log [ Time Frame: Change post treatment (6 weeks from baseline) compared to baseline ]
  6. Upper limb subscale of Fugl Meyer Assessment of Sensorimotor recovery after stroke [ Time Frame: 6 months follow-up ]
  7. Adverse events [ Time Frame: 6 months follow-up ]
  8. Fatigue Severity Scale [ Time Frame: Change post treatment (6 weeks from baseline) compared to baseline ]
  9. Pittsburgh Sleep Quality Index [ Time Frame: Change post treatment (6 weeks from baseline) compared to baseline ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02416791


Locations
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Brazil
Hospital das Clínicas
São Paulo, SP, Brazil, 05403900
Sponsors and Collaborators
University of Sao Paulo General Hospital
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
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Principal Investigator: Adriana B Conforto, MD Phd Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo/Fundação Faculdade de Medicina

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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02416791     History of Changes
Other Study ID Numbers: 513.207
First Posted: April 15, 2015    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: December 2015

Keywords provided by University of Sao Paulo General Hospital:
robotic therapy
transcranial direct current stimulation

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases