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

Terminated

Phase N/A Results N/A

Trial Description

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.

Trial Stopped: Because of low recruitment rates

Conditions

Interventions

  • Occupational therapy Other
    Intervention Desc: Occupational therapy will be administered for 40 minutes.
    ARM 1: Kind: Experimental
    Label: sham tDCS + PT + OT
    Description: 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).
    ARM 2: Kind: Experimental
    Label: sham tDCS + physical therapy + occupational therapy
    Description: 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).
  • Physical therapy Other
    Intervention Desc: Physical therapy will be administered for 40 minutes.
    ARM 1: Kind: Experimental
    Label: Active tDCS + robotic therapy + PT
    Description: 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).
    ARM 2: Kind: Experimental
    Label: sham tDCS + robotic therapy + PT
    Description: 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).
    ARM 3: Kind: Experimental
    Label: sham tDCS + PT + OT
    Description: 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).
    ARM 4: Kind: Experimental
    Label: Active tDCS + robotic therapy + physical therapy
    Description: 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).
    ARM 5: Kind: Experimental
    Label: sham tDCS + robotic therapy + physical therapy
    Description: 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).
    ARM 6: Kind: Experimental
    Label: sham tDCS + physical therapy + occupational therapy
    Description: 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).
  • Robotic therapy Device
    Intervention Desc: Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.
    ARM 1: Kind: Experimental
    Label: Active tDCS + robotic therapy + PT
    Description: 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).
    ARM 2: Kind: Experimental
    Label: sham tDCS + robotic therapy + PT
    Description: 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).
    ARM 3: Kind: Experimental
    Label: Active tDCS + robotic therapy + physical therapy
    Description: 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).
    ARM 4: Kind: Experimental
    Label: sham tDCS + robotic therapy + physical therapy
    Description: 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).
  • Sham tDCS Device
    Intervention Desc: In sham tDCS, no current will be delivered through the tDCS device.
    ARM 1: Kind: Experimental
    Label: sham tDCS + robotic therapy + PT
    Description: 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).
    ARM 2: Kind: Experimental
    Label: sham tDCS + PT + OT
    Description: 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).
    ARM 3: Kind: Experimental
    Label: sham tDCS + robotic therapy + physical therapy
    Description: 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).
    ARM 4: Kind: Experimental
    Label: sham tDCS + physical therapy + occupational therapy
    Description: 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).
  • Active tDCS Device
    Intervention Desc: 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).
    ARM 1: Kind: Experimental
    Label: Active tDCS + robotic therapy + PT
    Description: 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).
    ARM 2: Kind: Experimental
    Label: Active tDCS + robotic therapy + physical therapy
    Description: 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).

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Upper limb subscale of Fugl Meyer Assessment of Sensorimotor recovery after stroke Improvement post treatment (6 weeks from baseline) compared to baseline No
Primary Adverse events Improvement post treatment (6 weeks from baseline) compared to baseline Yes
Secondary Modified Rankin Scale Improvement post treatment (6 weeks from baseline) compared to baseline No
Secondary NIH Stroke Scale Improvement post treatment (Improvement post treatment (6 weeks from baseline) compared to baseline No
Secondary Stroke Impact Scale Improvement post treatment (6 weeks from baseline) compared to baseline No
Secondary Modified Ashworth Scale Improvement post treatment (6 weeks from baseline) compared to baseline No
Secondary Motor Activity Log Improvement post treatment (6 weeks from baseline) compared to baseline No
Secondary Fatigue Severity Scale Improvement post treatment (6 weeks from baseline) compared to baseline No
Secondary Pittsburgh Sleep Quality Index Improvement post treatment (6 weeks from baseline) compared to baseline No

Sponsors