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

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ClinicalTrials.gov Identifier: NCT03465631
Recruitment Status : Unknown
Verified March 2018 by Joon-Ho Shin, National Rehabilitation Center, Seoul, Korea.
Recruitment status was:  Recruiting
First Posted : March 14, 2018
Last Update Posted : March 14, 2018
Sponsor:
Information provided by (Responsible Party):
Joon-Ho Shin, National Rehabilitation Center, Seoul, Korea

Study Description
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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).

Condition or disease Intervention/treatment Phase
Stroke Device: SMART Glove system with tDCS Device: SMART Glove system with sham-tDCS Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : August 9, 2016
Estimated Primary Completion Date : March 31, 2018
Estimated Study Completion Date : March 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Stroke Impact Scale (SIS) [ Time Frame: pre-intervention after 1 week of baseline (T1), after 5 weeks of intervention (T2) ]
    Change of SIS scores


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03465631


Contacts
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Contact: Joon-Ho Shin, MS 82-2-901-1884 asfreelyas@gmail.com

Locations
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Korea, Republic of
National Rehabilitation Center Recruiting
Seoul, Korea, Republic of, 142884
Contact: Joon-Ho Shin, MS         
Principal Investigator: Joon-Ho Shin, MS         
Sponsors and Collaborators
National Rehabilitation Center, Seoul, Korea
Investigators
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Principal Investigator: Joon-Ho Shin, MS National Rehabilitation Center
More Information
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Responsible Party: Joon-Ho Shin, Team manager, National Rehabilitation Center, Seoul, Korea
ClinicalTrials.gov Identifier: NCT03465631    
Other Study ID Numbers: NRC-2016-03-026
First Posted: March 14, 2018    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joon-Ho Shin, National Rehabilitation Center, Seoul, Korea:
stroke rehabilitation
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases