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Trial record 3 of 44 for:    NOT MRI NOT Imaging NOT intensive NOT auditory NOT thermal NOT mirror NOT TENS NOT tactile NOT motion NOT Passy NOT music NOT flow NOT vibration NOT fluid NOT ASIS NOT traditional | Recruiting, Not yet recruiting, Available Studies | Stroke | Deep Brain Stimulation OR magnetic OR transcranial direct current

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

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ClinicalTrials.gov Identifier: NCT04054102
Recruitment Status : Recruiting
First Posted : August 13, 2019
Last Update Posted : August 13, 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.

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

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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 Reaching Function of Upper Extremity Among Subjects With Subacute 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
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
Other Name: Robot used in this study is Armeo spring

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
Other Name: Robot used in this study is Armeo spring




Primary Outcome Measures :
  1. Change of kinematic data during scale for the assessment and rating of ataxia [ Time Frame: Change from baseline at 4 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, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 12 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, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 12 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, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline ]
    an activity indicator, has 15 items for testing functional ability

  4. Motor activity log [ Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 12 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, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline ]
    to assess upper extremity performance (coordination, dexterity and functioning) in stroke recovery



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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): NCT04054102


Contacts
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Contact: Joon-Ho Shin, MS 82-2-901-1884 asfreelyas@gmail.com

Locations
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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
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Principal Investigator: Joon-Ho Shin, MS National Rehabilitation Center

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Responsible Party: Joon-Ho Shin, Team manager, National Rehabilitation Center, Seoul, Korea
ClinicalTrials.gov Identifier: NCT04054102     History of Changes
Other Study ID Numbers: NRC-2018-01-002
First Posted: August 13, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019

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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:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases