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

Study Overview
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Brief Summary
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Comparison of real transcranial direct current stimulation (tDCS) and sham tDCS combined with robot training for upper extremity rehabilitation in subjects with chronic stroke - delayed start study.

Official Title
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Effects of Upper Extremity Rehabilitation Robot and Transcranial Direct Current Stimulation on Upper Extremity Function Among Subjects With Chronic Stroke

Conditions
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Stroke

Intervention / Treatment
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* Device: Robot and tDCS on-line
* Device: Robot and tDCS on-line after sham tDCS


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robot and tDCS on-line<br>Combined transcranial direct current stimulation(tDCS) on-line and upper extremity rehabilitation robot for 10 weeks | Device: Robot and tDCS on-line<br>* Combined transcranial direct current stimulation(tDCS) on-line and upper extremity rehabilitation robot for 5 times a week for 10 weeks<br>|
| Active Comparator: Robot and tDCS on-line after sham tDCS<br>Combined sham tDCS and upper extremity rehabilitation robot for 5 weeks, followed by combined tDCS on-line and upper extremity rehabilitation robot for 5 weeks | Device: Robot and tDCS on-line after sham tDCS<br>* Combined sham tDCS and upper extremity rehabilitation robot for 5 times a week for 5 weeks, followed by combined tDCS on-line and upper extremity rehabilitation robot for 5 times a week for 5 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| kinematic data during scale for the assessment | kinematic data during scale for the assessment and rating of ataxia using Trakstar (mean velocity, jerk, smoothness) | 5 weeks after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| kinematic data during scale for the assessment | kinematic data during scale for the assessment and rating of ataxia using Trakstar (mean velocity, jerk, smoothness) | baseline, 1 weeks after baseline, 5 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline | 
| Fugl-Meyer Assessment - upper extremity | indicator of the level of impairment of upper extremity, with higher scores indicating lower impairment | baseline, 1 weeks after baseline, 5 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline | 
| Wolf Motor Function Test | an activity indicator, has 15 items for testing functional ability | baseline, 1 weeks after baseline, 5 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline | 
| Motor activity log | Assesses the use of the paretic arm and hand during activities of daily living in hemiparetic stroke patients. | baseline, 1 weeks after baseline, 5 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline | 
| Action reach arm test | to assess upper extremity performance (coordination, dexterity and functioning) in stroke recovery | baseline, 1 weeks after baseline, 5 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, transcranial direct current stimulation, upper extremity rehabilitation robot