NCT03465631

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 9, 2016

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 14, 2018

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
Last Updated

March 14, 2018

Status Verified

March 1, 2018

Enrollment Period

1.6 years

First QC Date

March 8, 2018

Last Update Submit

March 8, 2018

Conditions

Stroke

Keywords

stroke rehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Fugl-Meyer assessment of the upper extremity (FMA)

    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)

    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

    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)

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

Study Arms (2)

SMART Glove system with dual-tDCS

EXPERIMENTAL

VR-based SMART Glove system with dual-tDCS

Device: SMART Glove system with tDCS

SMART Glove system with sham-tDCS

SHAM COMPARATOR

VR-based SMART Glove system with sham-tDCS

Device: SMART Glove system with sham-tDCS

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 dual-tDCS
SMART Glove system with sham-tDCSDEVICE

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

SMART Glove system with sham-tDCS

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Rehabilitation Center

Seoul, 142884, South Korea

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Joon-Ho Shin, MS

    National Rehabilitation Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joon-Ho Shin, MS

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Team manager

Study Record Dates

First Submitted

March 8, 2018

First Posted

March 14, 2018

Study Start

August 9, 2016

Primary Completion

March 31, 2018

Study Completion

March 31, 2018

Last Updated

March 14, 2018

Record last verified: 2018-03

Locations

KR(1)