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

National Rehabilitation Center, Seoul, Korea20 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Stroke

Interventions

SMART Glove system with tDCSDEVICE

combined bilateral tDCS and VR-based therapy on distal upper extremity training in patients with stroke.

SMART Glove system with sham-tDCSDEVICE

combined bilateral tDCS and VR-based therapy on distal upper extremity training in patients with stroke.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

National Rehabilitation Center

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Box and block test

Change of box and block test scores

Time frame: baseline (T0), pre-intervention after 1 week of baseline (T1), after 5 weeks of intervention (T2), and at 4 weeks post-intervention (T3)

Secondary Outcomes

Fugl-Meyer assessment of the upper extremity (FMA)

Change of FMA scores

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: pre-intervention after 1 week of baseline (T1), after 5 weeks of intervention (T2)

Central Contacts

Joon-Ho Shin, MS

CONTACT

82-2-901-1884 asfreelyas@gmail.com

Data from ClinicalTrials.gov

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