Robotic Therapy and Transcranial Direct Current Stimulation in Patients With Stroke

Stroke Clinical Trial

— ROTS  

Official title:

Robotic Therapy and Transcranial Direct Current Stimulation in Patients With Stroke

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02416791
• Other study ID #: 513.207
• Status: Terminated
• Phase: N/A
• Start date: June 2015
• Est. completion date: December 2016

Study information

• Verified date: December 2015
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• 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).
• 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.
• Occupational Therapy
Occupational therapy will be administered for 40 minutes.

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	6 weeks from baseline
Primary	Percentage of Sessions With Adverse Events		Post treatment (6 weeks from baseline).
Secondary	Change in Modified Rankin Scale	Scores range from 0 to 6. Higher scores indicate greater severity.	6 weeks from baseline
Secondary	Change in National Institutes of Health Stroke Scale	Scores range from 0 to 42. Higher scores indicate greater severity.	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.	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.	6 weeks
Secondary	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
Secondary	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
Secondary	Number of Participants With Adverse Events		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.	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.	6 weeks from baseline