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

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

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

Conditions
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Stroke

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


Participation Criteria
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Eligibility Criteria
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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

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: Quadruple


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 | Other: 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 4 weeks<br>|
| Sham Comparator: Robot and sham tDCS<br>Combined sham tDCS and upper extremity rehabilitation robot | Other: Robot and sham tDCS<br>* Combined sham tDCS and upper extremity rehabilitation robot for 5 times a week for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Scale for the assessment and rating of ataxia | Change of Scale for the assessment and rating of ataxia | Change of Scale for the assessment and rating of ataxia at 4 weeks after baseline compared to baseline | 
| Change of Functional ataxia rating scale - upper limb | Change of Functional ataxia rating scale - upper limb | Change of the Functional ataxia rating scale - upper limb, at 4 weeks after baseline compared to baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment - upper extremity | Fugl-Meyer Assessment - upper extremity | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Composite cerebellar functional severity score | Composite cerebellar functional severity score (Nine hole peg test + click test) | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Jerk during reaching and finger pointing | Kinematic data during reaching and finger pointing using Trakstar | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Smoothness during reaching and finger pointing | Kinematic data during reaching and finger pointing using Trakstar | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Behavioral activation system/behavioral inhibition system scale | In terms of motivation | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Beck's depression index | Beck's depression index | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Stroke rehabilitation motivation scale | Stroke rehabilitation motivation scale | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Intrinsic motivation inventory | Intrinsic motivation inventory | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Numeric rating scale for upper extremity pain | Question about the upper extremity pain (0-10; higher is better) | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Functional reaching test | Functional reaching test | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| modified Barthel index | 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 | data from surface electromyography 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 | 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 | 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 | Functional ataxia rating scale - upper limb, kinematic data during scale for the assessment | 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 | 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 | 

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