Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04005131
Recruitment Status : Recruiting
First Posted : July 2, 2019
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
Joon-Ho Shin, National Rehabilitation Center, Seoul, Korea

Brief Summary:
Comparison of real transcranial direct current stimulation (tDCS) and sham tDCS combined with robot training for upper extremity rehabilitation in subjects with chronic stroke - delayed start study.

Condition or disease Intervention/treatment Phase
Stroke Device: Robot and tDCS on-line Device: Robot and tDCS on-line after sham tDCS Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Participant does not know the allocation.
Primary Purpose: Treatment
Official Title: Effects of Upper Extremity Rehabilitation Robot and Transcranial Direct Current Stimulation on Upper Extremity Function Among Subjects With Chronic Stroke
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Robot and tDCS on-line
Combined transcranial direct current stimulation(tDCS) on-line and upper extremity rehabilitation robot for 10 weeks
Device: Robot and tDCS on-line
Combined transcranial direct current stimulation(tDCS) on-line and upper extremity rehabilitation robot for 5 times a week for 10 weeks

Active Comparator: Robot and tDCS on-line after sham tDCS
Combined sham tDCS and upper extremity rehabilitation robot for 5 weeks, followed by combined tDCS on-line and upper extremity rehabilitation robot for 5 weeks
Device: Robot and tDCS on-line after sham tDCS
Combined sham tDCS and upper extremity rehabilitation robot for 5 times a week for 5 weeks, followed by combined tDCS on-line and upper extremity rehabilitation robot for 5 times a week for 5 weeks




Primary Outcome Measures :
  1. kinematic data during scale for the assessment [ Time Frame: 5 weeks after baseline ]
    kinematic data during scale for the assessment and rating of ataxia using Trakstar (mean velocity, jerk, smoothness)


Secondary Outcome Measures :
  1. kinematic data during scale for the assessment [ Time Frame: baseline, 1 weeks after baseline, 5 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline ]
    kinematic data during scale for the assessment and rating of ataxia using Trakstar (mean velocity, jerk, smoothness)

  2. Fugl-Meyer Assessment - upper extremity [ Time Frame: baseline, 1 weeks after baseline, 5 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline ]
    indicator of the level of impairment of upper extremity, with higher scores indicating lower impairment

  3. Wolf Motor Function Test [ Time Frame: baseline, 1 weeks after baseline, 5 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline ]
    an activity indicator, has 15 items for testing functional ability

  4. Motor activity log [ Time Frame: baseline, 1 weeks after baseline, 5 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline ]
    Assesses the use of the paretic arm and hand during activities of daily living in hemiparetic stroke patients.

  5. Action reach arm test [ Time Frame: baseline, 1 weeks after baseline, 5 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline ]
    to assess upper extremity performance (coordination, dexterity and functioning) in stroke recovery



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04005131


Contacts
Layout table for location contacts
Contact: Joon-Ho Shin 82-2-901-1884 asfreelyas@gmail.com

Locations
Layout table for location information
Korea, Republic of
National Rehabilitation Center Recruiting
Seoul, Korea, Republic of, 142884
Contact: Joon-Ho Shin, MS         
Principal Investigator: Joon-Ho Shin, MS         
Sponsors and Collaborators
National Rehabilitation Center, Seoul, Korea
Investigators
Layout table for investigator information
Principal Investigator: Joon-Ho Shin National Rehabilitation Center

Layout table for additonal information
Responsible Party: Joon-Ho Shin, Team manager, National Rehabilitation Center, Seoul, Korea
ClinicalTrials.gov Identifier: NCT04005131     History of Changes
Other Study ID Numbers: NRC-2018-01-003
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: June 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joon-Ho Shin, National Rehabilitation Center, Seoul, Korea:
stroke
transcranial direct current stimulation
upper extremity rehabilitation robot
Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases