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

Sponsor
National Rehabilitation Center, Seoul, Korea (Other)
Overall Status
Unknown status
CT.gov ID
NCT04054102
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
20
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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
  • Other: Robot and tDCS on-line
  • Other: Robot and sham tDCS
 N/A

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Primary Completion Date :
Dec 31, 2019
Anticipated Study Completion Date :
Dec 31, 2019

Arms and Interventions

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 Names:
  • 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 Names:
  • Robot used in this study is Armeo spring

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change of kinematic data during scale for the assessment and rating of ataxia [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 [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 [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 [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 [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 [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Rehabilitation Center Seoul Korea, Republic of 142884

    Sponsors and Collaborators

    • National Rehabilitation Center, Seoul, Korea

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Joon-Ho Shin, Team manager, National Rehabilitation Center, Seoul, Korea
    ClinicalTrials.gov Identifier:
    NCT04054102
    Other Study ID Numbers:
    • NRC-2018-01-002
    First Posted:
    Aug 13, 2019
    Last Update Posted:
    Aug 13, 2019
    Last Verified:
    Aug 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Joon-Ho Shin, Team manager, National Rehabilitation Center, Seoul, Korea
    stroke
    transcranial direct current stimulation
    upper extremity rehabilitation robot
    Additional relevant MeSH terms:
    Stroke

    Study Results

    No Results Posted as of Aug 13, 2019