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Clinical Trials/NCT04054102
NCT04054102
Unknown
Not Applicable

Effects of Upper Extremity Rehabilitation Robot and Transcranial Direct Current Stimulation on Reaching Function of Upper Extremity Among Subjects With Subacute Stroke

National Rehabilitation Center, Seoul, Korea1 site in 1 country20 target enrollmentMay 1, 2018
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
National Rehabilitation Center, Seoul, Korea
Enrollment
20
Locations
1
Primary Endpoint
Change of kinematic data during scale for the assessment and rating of ataxia
Last Updated
6 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
May 1, 2018
End Date
December 31, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
National Rehabilitation Center, Seoul, Korea
Responsible Party
Principal Investigator
Principal Investigator

Joon-Ho Shin

Team manager

National Rehabilitation Center, Seoul, Korea

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.

Outcomes

Primary Outcomes

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 Outcomes

  • Motor activity log(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline)
  • kinematic data during scale for the assessment(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline)
  • Fugl-Meyer Assessment - upper extremity(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline)
  • Wolf Motor Function Test(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline)
  • Action reach arm test(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline)

Study Sites (1)

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