Upper Extremity Rehabilitation Using SMART Glove System With Transcranial Direct Current Stimulation

Study Overview
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Brief Summary
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The aim of this study to investigate the effect of combined bilateral tDCS and VR-based therapy on distal upper extremity training in patients with stroke. We hypothesized that experimental group (VR-based training with dual-tDCS) would improve distal upper extremity function rather than control group (VR-based training with dual sham tDCS).

Detailed Description
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This is a double-blind, randomized controlled study. Patients were randomly assigned to 1 : 1 ratio to experimental group (VR-based training with dual-tDCS; VR-Dual) or the control group (VR-based training with dual sham tDCS; VR-Sham) . For both conditions, VR-Dual and VR-Sham group commenced at the same time (20 minutes). The therapist and patients were blinded as to whether the patients received real or sham tDCS. The study was approved by the Ethics Committee of the National Rehabilitation Center, Korea, and all participants provided written informed consent before enrollment.

Official Title
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Distal Upper Extremity Rehabilitation Using SMART Glove System With Transcranial Direct Current Stimulation (tDCS) for Stroke Patients : a Double-blinded, Randomized Controlled Trial

Conditions
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Stroke

Intervention / Treatment
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* Device: SMART Glove system with tDCS
* Device: SMART Glove system with sham-tDCS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: first-time ischemic or hemorrhagic stroke unilateral upper extremity functional deficits after stroke presence of a score of at least 3 points on the Medical Research Council (MRC) a score ≥ 4 on the Brunnstrom stage a score ≥ 25 on the Korean version of the Mini-Mental Status Exam (K-MMSE) Exclusion Criteria: age < 20 years wrist and finger spasticity with the Modified Ashworth Scale (MAS) score ≥ 2 uncontrolled hypertension, heart problems, infection, or any history of seizure or epilepsy neurological disorders that cause motor deficits being unable to perform the task or to understand instructions presence of pacemaker, pregnancy, cognitive impairment, or psychiatric disorders

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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: SMART Glove system with dual-tDCS<br>VR-based SMART Glove system with dual-tDCS | Device: SMART Glove system with tDCS<br>* combined bilateral tDCS and VR-based therapy on distal upper extremity training in patients with stroke.<br>|
| Sham Comparator: SMART Glove system with sham-tDCS<br>VR-based SMART Glove system with sham-tDCS | Device: SMART Glove system with sham-tDCS<br>* combined bilateral tDCS and VR-based therapy on distal upper extremity training in patients with stroke.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Box and block test | Change of box and block test scores | baseline (T0), pre-intervention after 1 week of baseline (T1), after 5 weeks of intervention (T2), and at 4 weeks post-intervention (T3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer assessment of the upper extremity (FMA) | Change of FMA scores | baseline (T0), pre-intervention after 1 week of baseline (T1), after 5 weeks of intervention (T2), and at 4 weeks post-intervention (T3) | 
| Jebsen Taylor Hand Function Test (JTT) | Change of JTT scores | baseline (T0), pre-intervention after 1 week of baseline (T1), after 5 weeks of intervention (T2), and at 4 weeks post-intervention (T3) | 
| Grip strength | Change of Grip strength (JAMAR) scores | baseline (T0), pre-intervention after 1 week of baseline (T1), after 5 weeks of intervention (T2), and at 4 weeks post-intervention (T3) | 
| Stroke Impact Scale (SIS) | Change of SIS scores | pre-intervention after 1 week of baseline (T1), after 5 weeks of intervention (T2) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke rehabilitation