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

National Rehabilitation Center, Seoul, Korea

Status: Unknown

Conditions: Stroke

Treatments: Device: SMART Glove system with sham-tDCS; Device: SMART Glove system with tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT03465631

NRC-2016-03-026

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

SMART Glove system with dual-tDCS

Experimental group

Description:

VR-based SMART Glove system with dual-tDCS

Treatment:

Device: SMART Glove system with tDCS

SMART Glove system with sham-tDCS

Sham Comparator group

Description:

VR-based SMART Glove system with sham-tDCS

Treatment:

Device: SMART Glove system with sham-tDCS