Effects of Upper Extremity Rehabilitation Robot and Transcranial Direct Current Stimulation Among Patients With Stroke

August 12, 2019 updated by: Joon-Ho Shin, National Rehabilitation Center, Seoul, Korea

Effects of Upper Extremity Rehabilitation Robot and Transcranial Direct Current Stimulation on Upper Extremity Function Among Subjects With Tremor After Cerebellar and Brainstem Stroke

Effects of upper extremity rehabilitation robot and transcranial direct current stimulation on upper extremity function among subjects with tremor after stroke

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 142884
        • Recruiting
        • National Rehabilitation Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Stroke with cerebellar hemorrhage or infarction
  • ataxia or tremor on upper extremities secondary to stroke
  • Cognitively intact enough to understand and follow the instructions from the investigator

Exclusion Criteria:

  • History of surgery of affected upper limb
  • Fracture of affected upper limb

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Robot and tDCS on-line
Combined transcranial direct current stimulation(tDCS) on-line and upper extremity rehabilitation robot
Other: Robot and tDCS on-line
Combined transcranial direct current stimulation(tDCS) on-line and upper extremity rehabilitation robot for 5 times a week for 4 weeks
Sham Comparator: Robot and sham tDCS
Combined sham tDCS and upper extremity rehabilitation robot
Other: Robot and sham tDCS
Combined sham tDCS and upper extremity rehabilitation robot for 5 times a week for 4 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of Scale for the assessment and rating of ataxia
Time Frame: Change of Scale for the assessment and rating of ataxia at 4 weeks after baseline compared to baseline
Change of Scale for the assessment and rating of ataxia
Change of Scale for the assessment and rating of ataxia at 4 weeks after baseline compared to baseline
Change of Functional ataxia rating scale - upper limb
Time Frame: Change of the Functional ataxia rating scale - upper limb, at 4 weeks after baseline compared to baseline
Change of Functional ataxia rating scale - upper limb
Change of the Functional ataxia rating scale - upper limb, at 4 weeks after baseline compared to baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Assessment - upper extremity
Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Fugl-Meyer Assessment - upper extremity
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Composite cerebellar functional severity score
Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Composite cerebellar functional severity score (Nine hole peg test + click test)
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Jerk during reaching and finger pointing
Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Kinematic data during reaching and finger pointing using Trakstar
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Smoothness during reaching and finger pointing
Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Kinematic data during reaching and finger pointing using Trakstar
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Behavioral activation system/behavioral inhibition system scale
Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
In terms of motivation
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Beck's depression index
Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Beck's depression index
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Stroke rehabilitation motivation scale
Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Stroke rehabilitation motivation scale
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Intrinsic motivation inventory
Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Intrinsic motivation inventory
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Numeric rating scale for upper extremity pain
Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Question about the upper extremity pain (0-10; higher is better)
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Functional reaching test
Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Functional reaching test
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
modified Barthel index
Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
modified Barthel index
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
% maximal voluntary contraction from upper extremity muscles during reaching task
Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
data from surface electromyography from upper extremity muscles during reaching task
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Kinematic data during scale for the assessment and rating of ataxia
Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Kinematic data during scale for the assessment and rating of ataxia
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Scale for the assessment and rating of ataxia
Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Scale for the assessment and rating of ataxia
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Functional ataxia rating scale - upper limb
Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Functional ataxia rating scale - upper limb, kinematic data during scale for the assessment
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Kinematic data during scale during the Functional ataxia rating scale - upper limb
Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Kinematic data during scale during the Functional ataxia rating scale - upper limb
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Rehabilitation Center, Seoul, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 1, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NRC-2017-01-004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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