Back to resultsUpper Extremity Rehabilitation Using SMART Glove System With Transcranial Direct Current Stimulation
Primary Purpose
Stroke
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
SMART Glove system with tDCS
SMART Glove system with sham-tDCS
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke rehabilitation
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
Sites / Locations
- National Rehabilitation CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
SMART Glove system with dual-tDCS
SMART Glove system with sham-tDCS
Arm Description
VR-based SMART Glove system with dual-tDCS
VR-based SMART Glove system with sham-tDCS
Outcomes
Primary Outcome Measures
Box and block test
Change of box and block test scores
Secondary Outcome Measures
Fugl-Meyer assessment of the upper extremity (FMA)
Change of FMA scores
Jebsen Taylor Hand Function Test (JTT)
Change of JTT scores
Grip strength
Change of Grip strength (JAMAR) scores
Stroke Impact Scale (SIS)
Change of SIS scores
Full Information
NCT ID
NCT03465631
First Posted
March 8, 2018
Last Updated
March 8, 2018
Sponsor
National Rehabilitation Center, Seoul, Korea
1. Study Identification
Unique Protocol Identification Number
NCT03465631
Brief Title
Upper Extremity Rehabilitation Using SMART Glove System With Transcranial Direct Current Stimulation
Official Title
Distal Upper Extremity Rehabilitation Using SMART Glove System With Transcranial Direct Current Stimulation (tDCS) for Stroke Patients : a Double-blinded, Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 9, 2016 (Actual)
Primary Completion Date
March 31, 2018 (Anticipated)
Study Completion Date
March 31, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Rehabilitation Center, Seoul, Korea
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SMART Glove system with dual-tDCS
Arm Type
Experimental
Arm Description
VR-based SMART Glove system with dual-tDCS
Arm Title
SMART Glove system with sham-tDCS
Arm Type
Sham Comparator
Arm Description
VR-based SMART Glove system with sham-tDCS
Intervention Type
Device
Intervention Name(s)
SMART Glove system with tDCS
Intervention Description
combined bilateral tDCS and VR-based therapy on distal upper extremity training in patients with stroke.
Intervention Type
Device
Intervention Name(s)
SMART Glove system with sham-tDCS
Intervention Description
combined bilateral tDCS and VR-based therapy on distal upper extremity training in patients with stroke.
Primary Outcome Measure Information:
Title
Box and block test
Description
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 Outcome Measure Information:
Title
Fugl-Meyer assessment of the upper extremity (FMA)
Description
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)
Title
Jebsen Taylor Hand Function Test (JTT)
Description
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)
Title
Grip strength
Description
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)
Title
Stroke Impact Scale (SIS)
Description
Change of SIS scores
Time Frame
pre-intervention after 1 week of baseline (T1), after 5 weeks of intervention (T2)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joon-Ho Shin, MS
Phone
82-2-901-1884
Email
asfreelyas@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joon-Ho Shin, MS
Organizational Affiliation
National Rehabilitation Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Rehabilitation Center
City
Seoul
ZIP/Postal Code
142884
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joon-Ho Shin, MS
First Name & Middle Initial & Last Name & Degree
Joon-Ho Shin, MS
12. IPD Sharing Statement
Learn more about this trial
Upper Extremity Rehabilitation Using SMART Glove System With Transcranial Direct Current Stimulation
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