Robotic Therapy and Transcranial Direct Current Stimulation in Patients With Stroke

NCT ID: NCT02416791

Last Updated: 2020-10-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2016-12-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

Robotic Therapy

Intervention Type: DEVICE

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

Active tDCS

Intervention Type: 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).

Physical Therapy

Intervention Type: OTHER

Physical therapy will be administered for 40 minutes.

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).

Group Type: ACTIVE_COMPARATOR

Robotic Therapy

Intervention Type: DEVICE

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

Sham tDCS

Intervention Type: DEVICE

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

Physical Therapy

Intervention Type: OTHER

Physical therapy will be administered for 40 minutes.

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).

Group Type: EXPERIMENTAL

Sham tDCS

Intervention Type: DEVICE

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

Physical Therapy

Intervention Type: OTHER

Physical therapy will be administered for 40 minutes.

Occupational Therapy

Intervention Type: OTHER

Occupational therapy will be administered for 40 minutes.

Interventions

Robotic Therapy

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

Intervention Type: 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).

Intervention Type: DEVICE

Sham tDCS

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

Intervention Type: DEVICE

Physical Therapy

Physical therapy will be administered for 40 minutes.

Intervention Type: OTHER

Occupational Therapy

Occupational therapy will be administered for 40 minutes.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adriana B Conforto, MD Phd

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

Hospital das Clínicas

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 33175411 (View on PubMed)

Other Identifiers

513.207

Identifier Type: -

Identifier Source: org_study_id