Back to resultsRobotic Therapy and Brain Stimulation in the Early Phase After Stroke
Primary Purpose
Stroke
Status
Active
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Robotic Therapy
Active stimulation
Sham stimulation
Sponsored by
About this trial
This is an interventional other trial for Stroke focused on measuring stroke, robotic therapy, transcranial direct current stimulation
Eligibility Criteria
Inclusion Criteria:
Ischemic or hemorrhagic stroke onset from 3 days to 9 weeks before, confirmed by computed tomography or magnetic resonance imaging.
Motor impairment of an upper limb, defined as a score between 1 - 3 in the Medical Research Council Scale, for at lest one the following movements: elbow extension, shoulder flexion, or shoulder extension.
Ability to provide written informed consent.
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 in the Modified Ashworth Spasticity Scale.
No active shoulder and elbow movements
Uncontrolled medical problems such as end-stage cancer or renal disease
Pregnancy
Potential contraindications to transcranial direct current stimulation: history of seizures, lesions on the scalp, intracranial metal implants, prior intracranial surgery, use of drugs that interfere on cortical excitability (such as antiepileptic drugs, benzodiazepines)
Other neurological disorders such as Parkinson's disease
Psychiatric illness
Aphasia or severe cognitive deficits that compromise comprehension of the experimental protocol or ability to provide consent.
Hemineglect
Cerebellar lesions or on cerebellar pathways
Contact precautions
Sites / Locations
- Suzana Bleckmann Reis
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Active stimulation + robotic therapy
Sham stimulation + robotic therapy
Arm Description
Active transcranial direct current stimulation will be applied during 20 minutes prior to robotic training. Number of interventions sessions: 1
Sham transcranial direct current stimulation will be applied during 20 minutes prior to robotic training. Number of interventions sessions: 1
Outcomes
Primary Outcome Measures
Movement Smoothness
The speed shape, calculated as mean speed divided by peak speed.
Secondary Outcome Measures
Number of peaks of the movement
Number of peaks of the movement is calculated as the negative of the number of peaks in the speed profile.
Jerk metric of the movement
Jerk metric of the movement is calculated by dividing the negative mean jerk magnitude by the peak speed.
Full Information
NCT ID
NCT03230695
First Posted
July 24, 2017
Last Updated
October 27, 2022
Sponsor
University of Sao Paulo General Hospital
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
1. Study Identification
Unique Protocol Identification Number
NCT03230695
Brief Title
Robotic Therapy and Brain Stimulation in the Early Phase After Stroke
Official Title
Effects of Robotic Therapy and Transcranial Direct Current Stimulation on Motor Performance of the Paretic Upper Limb in the Early Phase After Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 3, 2017 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
July 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Stroke is the second cause of death worldwide and the majority of the survivors remain with motor impairments. Inhibition of the motor cortex of the unaffected hemisphere has emerged as a potential intervention to enhance effects of other rehabilitation strategies on improvement of motor performance of the paretic upper limb. In this proof-of-concept study we will evaluate the effects of inhibition of the motor cortex of the unaffected hemisphere associated with robotic therapy on improvement of motor performance of the paretic upper limb in the early phase post-stroke.
Detailed Description
The main goal of this study is to test the proof of concept of benefits of inhibition of the motor cortex of the unaffected hemisphere on learning evaluated by improvement in kinematics of motor performance, in patients with upper limb paresis in the early phase post-stroke. For this purpose, patients will be randomized to receive real or sham transcranial direct current stimulation before a session of robotic therapy. Data will be collected by kinematic assessment performed automatically by the robot at baseline, immediately after and 24h after the intervention.
The working hypothesis is that one session of upper limb motor training will lead to improvement of performance in metrics of kinematics, and this improvement will be maintained up to 24h after the end of the training.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, robotic therapy, transcranial direct current stimulation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active stimulation + robotic therapy
Arm Type
Active Comparator
Arm Description
Active transcranial direct current stimulation will be applied during 20 minutes prior to robotic training.
Number of interventions sessions: 1
Arm Title
Sham stimulation + robotic therapy
Arm Type
Sham Comparator
Arm Description
Sham transcranial direct current stimulation will be applied during 20 minutes prior to robotic training.
Number of interventions sessions: 1
Intervention Type
Device
Intervention Name(s)
Robotic Therapy
Intervention Description
Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.
Intervention Type
Device
Intervention Name(s)
Active stimulation
Intervention Description
Active transcranial direct current stimulation 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
Intervention Name(s)
Sham stimulation
Intervention Description
In sham transcranial direct current stimulation, no current will be delivered through the transcranial direct current stimulation device after the first 30 seconds.
Primary Outcome Measure Information:
Title
Movement Smoothness
Description
The speed shape, calculated as mean speed divided by peak speed.
Time Frame
Kinematic assessment at baseline, immediately after intervention; and 24h after.
Secondary Outcome Measure Information:
Title
Number of peaks of the movement
Description
Number of peaks of the movement is calculated as the negative of the number of peaks in the speed profile.
Time Frame
kinematic assessment at baseline, immediately after intervention; and 24h after.
Title
Jerk metric of the movement
Description
Jerk metric of the movement is calculated by dividing the negative mean jerk magnitude by the peak speed.
Time Frame
kinematic assessment at baseline, immediately after intervention; and 24h after
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ischemic or hemorrhagic stroke onset from 3 days to 9 weeks before, confirmed by computed tomography or magnetic resonance imaging.
Motor impairment of an upper limb, defined as a score between 1 - 3 in the Medical Research Council Scale, for at lest one the following movements: elbow extension, shoulder flexion, or shoulder extension.
Ability to provide written informed consent.
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 in the Modified Ashworth Spasticity Scale.
No active shoulder and elbow movements
Uncontrolled medical problems such as end-stage cancer or renal disease
Pregnancy
Potential contraindications to transcranial direct current stimulation: history of seizures, lesions on the scalp, intracranial metal implants, prior intracranial surgery, use of drugs that interfere on cortical excitability (such as antiepileptic drugs, benzodiazepines)
Other neurological disorders such as Parkinson's disease
Psychiatric illness
Aphasia or severe cognitive deficits that compromise comprehension of the experimental protocol or ability to provide consent.
Hemineglect
Cerebellar lesions or on cerebellar pathways
Contact precautions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adriana B Conforto, D, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Suzana Bleckmann Reis
City
São Paulo
ZIP/Postal Code
05403900
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Robotic Therapy and Brain Stimulation in the Early Phase After Stroke
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