CClinicalTrials.gg
Status unknownNCT03465631Updated Mar 14, 2018

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

An interventional study of SMART Glove system with tDCS and SMART Glove system with sham-tDCS in Stroke, sponsored by National Rehabilitation Center, Seoul, Korea. Status unknown at 1 site in Korea, Republic of. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-03-14.

Sponsored by National Rehabilitation Center, Seoul, Korea · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Stroke

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Keywords

  • stroke rehabilitation
03

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    SMART Glove system with dual-tDCS

    VR-based SMART Glove system with dual-tDCS

    Device: SMART Glove system with tDCS

  • Sham comparator
    SMART Glove system with sham-tDCS

    VR-based SMART Glove system with sham-tDCS

    Device: SMART Glove system with sham-tDCS

Interventions

  • DeviceSMART Glove system with tDCS

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

  • DeviceSMART Glove system with sham-tDCS

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

05

What researchers measure

Primary outcomes

  1. Box and block test

    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 outcomes

  1. Fugl-Meyer assessment of the upper extremity (FMA)

    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)

  2. Jebsen Taylor Hand Function Test (JTT)

    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)

  3. Grip strength

    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)

  4. Stroke Impact Scale (SIS)

    Change of SIS scores

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

06

Study locations

1 of 1 sites recruiting
  • National Rehabilitation Center
    Seoul, 142884, Korea, Republic of
    • Joon-Ho Shin, MS · Contact
    • Joon-Ho Shin, MS · Principal investigator
    Recruiting
07

Registry details

Key details

Study ID
NCT03465631
Lead sponsor
National Rehabilitation Center, Seoul, Korea
Responsible party
Joon-Ho Shin (Team manager, National Rehabilitation Center, Seoul, Korea) — Principal investigator
First posted
Mar 14, 2018
Start date
Aug 9, 2016
Primary completion
Mar 31, 2018 (estimated)
Completion
Mar 31, 2018 (estimated)
Last update
Mar 14, 2018

Study contacts

Joon-Ho Shin, MS
Contact
asfreelyas@gmail.com
82-2-901-1884
Joon-Ho Shin, MS
principal investigator · National Rehabilitation Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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