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

March 8, 2018 updated by: Joon-Ho Shin, National Rehabilitation Center, Seoul, Korea

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 142884
        • Recruiting
        • National Rehabilitation Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SMART Glove system with dual-tDCS
VR-based SMART Glove system with dual-tDCS
Device: SMART Glove system with tDCS
combined bilateral tDCS and VR-based therapy on distal upper extremity training in patients with stroke.
Sham Comparator: SMART Glove system with sham-tDCS
VR-based SMART Glove system with sham-tDCS
Device: SMART Glove system with sham-tDCS
combined bilateral tDCS and VR-based therapy on distal upper extremity training in patients with stroke.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Box and block test
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)
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)
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)
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)
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)
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
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)
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)
Time Frame: pre-intervention after 1 week of baseline (T1), after 5 weeks of intervention (T2)
Change of SIS scores
pre-intervention after 1 week of baseline (T1), after 5 weeks of intervention (T2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Rehabilitation Center, Seoul, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 9, 2016

Primary Completion (Anticipated)

March 31, 2018

Study Completion (Anticipated)

March 31, 2018

Study Registration Dates

First Submitted

March 8, 2018

First Submitted That Met QC Criteria

March 8, 2018

First Posted (Actual)

March 14, 2018

Study Record Updates

Last Update Posted (Actual)

March 14, 2018

Last Update Submitted That Met QC Criteria

March 8, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NRC-2016-03-026

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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