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Effects of Upper Extremity Rehabilitation Robot and Transcranial Direct Current Stimulation in Subacute Stroke

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Robot and tDCS on-line
Robot and sham tDCS
Sponsored by
National Rehabilitation Center, Seoul, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, transcranial direct current stimulation, upper extremity rehabilitation robot

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Hemiplegic patients secondary to first cerebrovascular accidents
  • Onset ≤ 6 months
  • Fugl-Meyer Assessment score ≥ 19
  • Cognitively intact enough to understand and follow the instructions from the investigator

Exclusion Criteria:

  • Severe upper extremity pain that could interfere with rehabilitation therapy
  • Neurological disorders other than stroke that can cause motor deficits
  • Uncontrolled severe medical conditions.

Sites / Locations

  • National Rehabilitation CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Robot and tDCS on-line

Robot and sham tDCS

Arm Description

Combined transcranial direct current stimulation(tDCS) on-line and upper extremity rehabilitation robot

Combined sham tDCS and upper extremity rehabilitation robot

Outcomes

Primary Outcome Measures

Change of kinematic data during scale for the assessment and rating of ataxia
kinematic data during scale for the assessment and rating of ataxia using Trakstar (mean velocity, jerk, smoothness)

Secondary Outcome Measures

kinematic data during scale for the assessment
kinematic data during scale for the assessment and rating of ataxia using Trakstar (mean velocity, jerk, smoothness)
Fugl-Meyer Assessment - upper extremity
indicator of the level of impairment of upper extremity, with higher scores indicating lower impairment
Wolf Motor Function Test
an activity indicator, has 15 items for testing functional ability
Motor activity log
Assesses the use of the paretic arm and hand during activities of daily living in hemiparetic stroke patients.
Action reach arm test
to assess upper extremity performance (coordination, dexterity and functioning) in stroke recovery

Full Information

First Posted
June 18, 2019
Last Updated
August 12, 2019
Sponsor
National Rehabilitation Center, Seoul, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT04054102
Brief Title
Effects of Upper Extremity Rehabilitation Robot and Transcranial Direct Current Stimulation in Subacute Stroke
Official Title
Effects of Upper Extremity Rehabilitation Robot and Transcranial Direct Current Stimulation on Reaching Function of Upper Extremity Among Subjects With Subacute Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Rehabilitation Center, Seoul, Korea

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
Comparison of real transcranial direct current stimulation (tDCS) and sham tDCS combined with robot training for upper extremity rehabilitation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, transcranial direct current stimulation, upper extremity rehabilitation robot

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participant does not know the allocation.
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Robot and tDCS on-line
Arm Type
Experimental
Arm Description
Combined transcranial direct current stimulation(tDCS) on-line and upper extremity rehabilitation robot
Arm Title
Robot and sham tDCS
Arm Type
Sham Comparator
Arm Description
Combined sham tDCS and upper extremity rehabilitation robot
Intervention Type
Other
Intervention Name(s)
Robot and tDCS on-line
Other Intervention Name(s)
Robot used in this study is Armeo spring
Intervention Description
Combined transcranial direct current stimulation(tDCS) on-line and upper extremity rehabilitation robot for 5 times a week for 4 weeks
Intervention Type
Other
Intervention Name(s)
Robot and sham tDCS
Other Intervention Name(s)
Robot used in this study is Armeo spring
Intervention Description
Combined sham tDCS and upper extremity rehabilitation robot for 5 times a week for 4 weeks
Primary Outcome Measure Information:
Title
Change of kinematic data during scale for the assessment and rating of ataxia
Description
kinematic data during scale for the assessment and rating of ataxia using Trakstar (mean velocity, jerk, smoothness)
Time Frame
Change from baseline at 4 weeks after baseline
Secondary Outcome Measure Information:
Title
kinematic data during scale for the assessment
Description
kinematic data during scale for the assessment and rating of ataxia using Trakstar (mean velocity, jerk, smoothness)
Time Frame
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
Title
Fugl-Meyer Assessment - upper extremity
Description
indicator of the level of impairment of upper extremity, with higher scores indicating lower impairment
Time Frame
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
Title
Wolf Motor Function Test
Description
an activity indicator, has 15 items for testing functional ability
Time Frame
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
Title
Motor activity log
Description
Assesses the use of the paretic arm and hand during activities of daily living in hemiparetic stroke patients.
Time Frame
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
Title
Action reach arm test
Description
to assess upper extremity performance (coordination, dexterity and functioning) in stroke recovery
Time Frame
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hemiplegic patients secondary to first cerebrovascular accidents Onset ≤ 6 months Fugl-Meyer Assessment score ≥ 19 Cognitively intact enough to understand and follow the instructions from the investigator Exclusion Criteria: Severe upper extremity pain that could interfere with rehabilitation therapy Neurological disorders other than stroke that can cause motor deficits Uncontrolled severe medical conditions.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joon-Ho Shin, MS
Phone
82-2-901-1884
Email
asfreelyas@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joon-Ho Shin, MS
Organizational Affiliation
National Rehabilitation Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Rehabilitation Center
City
Seoul
ZIP/Postal Code
142884
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joon-Ho Shin, MS
First Name & Middle Initial & Last Name & Degree
Joon-Ho Shin, MS

12. IPD Sharing Statement

Learn more about this trial

Effects of Upper Extremity Rehabilitation Robot and Transcranial Direct Current Stimulation in Subacute Stroke

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