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

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.

Study Overview

• Status: Terminated
• Conditions: Stroke
• Intervention / Treatment: Device: Robotic Therapy; Device: Active tDCS; Other: Physical Therapy; Device: Sham tDCS; Other: Occupational Therapy

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 Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 05403900
      • Hospital das Clínicas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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.; Other: Physical Therapy; Physical therapy will be administered for 40 minutes.; Device: Sham tDCS; In sham tDCS, no current will be delivered through the tDCS device.
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).	Other: Physical Therapy; Physical therapy will be administered for 40 minutes.; Device: Sham tDCS; In sham tDCS, no current will be delivered through the tDCS device.; Other: Occupational Therapy; Occupational therapy will be administered for 40 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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).

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico
• Investigators: Principal Investigator: Adriana B Conforto, MD Phd, University of Sao Paulo

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: February 20, 2015
• First Submitted That Met QC Criteria: April 9, 2015
• First Posted (Estimate): April 15, 2015

Study Record Updates

• Last Update Posted (Actual): October 20, 2020
• Last Update Submitted That Met QC Criteria: October 15, 2020
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: transcranial direct current stimulation; robotic therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 513.207

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No