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

Overview

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

Full Title of Study: “Effects of Upper Extremity Rehabilitation Robot and Transcranial Direct Current Stimulation on Upper Extremity Function Among Subjects With Tremor After Cerebellar and Brainstem Stroke”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 31, 2019

Interventions

  • 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: Robot and sham tDCS
    • Combined sham tDCS and upper extremity rehabilitation robot for 5 times a week for 4 weeks

Arms, Groups and Cohorts

  • Experimental: Robot and tDCS on-line
    • Combined transcranial direct current stimulation(tDCS) on-line and upper extremity rehabilitation robot
  • Sham Comparator: Robot and sham tDCS
    • Combined sham tDCS and upper extremity rehabilitation robot

Clinical Trial Outcome Measures

Primary Measures

  • 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 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

Secondary Measures

  • 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
  • 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)
  • 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
  • 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
  • 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
  • Beck’s depression index
    • Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
    • Beck’s depression index
  • Stroke rehabilitation motivation scale
    • Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
    • Stroke rehabilitation motivation scale
  • Intrinsic motivation inventory
    • Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
    • Intrinsic motivation inventory
  • 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)
  • Functional reaching test
    • Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
    • Functional reaching test
  • modified Barthel index
    • Time Frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
    • modified Barthel index
  • % 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
  • 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
  • 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
  • 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
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • National Rehabilitation Center, Seoul, Korea
  • Provider of Information About this Clinical Study
    • Principal Investigator: Joon-Ho Shin, Team manager – National Rehabilitation Center, Seoul, Korea
  • Overall Official(s)
    • Joon-Ho Shin, MS, Principal Investigator, National Rehabilitation Center
  • Overall Contact(s)
    • Joon-Ho Shin, MS, 82-2-901-1884, asfreelyas@gmail.com

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