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Clinical Trials/NCT04055597
NCT04055597
Unknown
Not Applicable

Effects of Upper Extremity Rehabilitation Robot and Transcranial Direct Current Stimulation on Upper Extremity Function Among Subjects With Tremor After Cerebellar and Brainstem Stroke

National Rehabilitation Center, Seoul, Korea1 site in 1 country40 target enrollmentJune 1, 2017
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
National Rehabilitation Center, Seoul, Korea
Enrollment
40
Locations
1
Primary Endpoint
Change of Functional ataxia rating scale - upper limb
Last Updated
6 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
June 1, 2017
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

  • 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

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

  • Fugl-Meyer Assessment - upper extremity(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
  • Composite cerebellar functional severity score(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
  • Jerk during reaching and finger pointing(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
  • Smoothness during reaching and finger pointing(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
  • Behavioral activation system/behavioral inhibition system scale(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
  • Beck's depression index(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
  • Stroke rehabilitation motivation scale(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
  • Intrinsic motivation inventory(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
  • Numeric rating scale for upper extremity pain(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
  • Functional reaching test(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
  • modified Barthel index(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
  • % maximal voluntary contraction from upper extremity muscles during reaching task(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
  • Kinematic data during scale for the assessment and rating of ataxia(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
  • Scale for the assessment and rating of ataxia(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
  • Functional ataxia rating scale - upper limb(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(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)

Study Sites (1)

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