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

NCT ID: NCT03465631

Last Updated: 2018-03-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-09
• Study Completion Date: 2018-03-31

Brief Summary

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

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

SMART Glove system with dual-tDCS

VR-based SMART Glove system with dual-tDCS

Group Type: EXPERIMENTAL

SMART Glove system with tDCS

Intervention Type: DEVICE

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

SMART Glove system with sham-tDCS

VR-based SMART Glove system with sham-tDCS

Group Type: SHAM_COMPARATOR

SMART Glove system with sham-tDCS

Intervention Type: DEVICE

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

Interventions

SMART Glove system with tDCS

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

Intervention Type: DEVICE

SMART Glove system with sham-tDCS

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Rehabilitation Center, Seoul, Korea

OTHER_GOV

Sponsor Role: lead

Responsible Party

Joon-Ho Shin

Team manager

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joon-Ho Shin, MS

Role: PRINCIPAL_INVESTIGATOR

National Rehabilitation Center

Locations

National Rehabilitation Center

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Joon-Ho Shin, MS

Role: CONTACT

asfreelyas@gmail.com

82-2-901-1884

Facility Contacts

Joon-Ho Shin, MS

Role: primary

Other Identifiers

NRC-2016-03-026

Identifier Type: -

Identifier Source: org_study_id