StrokeNCT03465631
Upper Extremity Rehabilitation Using SMART Glove System With Transcranial Direct Current Stimulation
A study testing SMART Glove system with tDCS in people with Stroke, run by National Rehabilitation Center, Seoul, Korea at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- SMART Glove system with tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Aug 2016to 31 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
National Rehabilitation Center
Seoul, 142884
Joon-Ho Shin, MS
Joon-Ho Shin, MS
About this study
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
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.
- Conditions
- Stroke
- Being tested
- SMART Glove system with tDCS, SMART Glove system with sham-tDCS
- Keywords
- stroke rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 sham-tDCSDevice
combined bilateral tDCS and VR-based therapy on distal upper extremity training in patients with stroke.
| Study group | Role | What they receive |
|---|---|---|
| SMART Glove system with dual-tDCS | Experimental | VR-based SMART Glove system with dual-tDCS Receives: Device: SMART Glove system with tDCS |
| SMART Glove system with sham-tDCS | Sham comparator | VR-based SMART Glove system with sham-tDCS Receives: Device: SMART Glove system with sham-tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Box and block test
Change of box and block test scores
Measured: 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)
Change of FMA scores
Measured: 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)
Change of JTT scores
Measured: 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
Change of Grip strength (JAMAR) scores
Measured: 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)
Change of SIS scores
Measured: pre-intervention after 1 week of baseline (T1), after 5 weeks of intervention (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start9 Aug 2016
- Primary completion31 Mar 2018 (estimated)
- Study completion31 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Rehabilitation Center, Seoul, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Joon-Ho Shin, National Rehabilitation Center, Seoul, Korea
- Investigators
- Joon-Ho Shin, MS, Principal investigator, National Rehabilitation Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03465631
- Sponsor's protocol ID
- NRC-2016-03-026
- Status last verified
- Mar 2018
- First submitted
- 8 Mar 2018
- Last updated
- 14 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03465631
- Acronym / sponsor ID
- NRC-2016-03-026
- Conditions
- Stroke
- Keywords
- stroke rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- National Rehabilitation Center, Seoul, KoreaOther government
- Study start
- 9 Aug 2016 (actual)
- Primary completion
- 31 Mar 2018 (estimated)
- Study completion
- 31 Mar 2018 (estimated)
- First posted
- 14 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMART Glove system with dual-tDCS | Experimental | Device: SMART Glove system with tDCSVR-based SMART Glove system with dual-tDCS |
| SMART Glove system with sham-tDCS | Sham comparator | Device: SMART Glove system with sham-tDCSVR-based SMART Glove system with sham-tDCS |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMART Glove system with tDCScombined bilateral tDCS and VR-based therapy on distal upper extremity training in patients with stroke. | Device | SMART Glove system with dual-tDCS |
| SMART Glove system with sham-tDCScombined bilateral tDCS and VR-based therapy on distal upper extremity training in patients with stroke. | Device | SMART Glove system with sham-tDCS |
Primary outcome
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
4 secondary outcomes
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)
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)
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)
Stroke Impact Scale (SIS)
Time frame: pre-intervention after 1 week of baseline (T1), after 5 weeks of intervention (T2)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joon-Ho Shin, MS principal investigator
National Rehabilitation Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMART Glove system with tDCS in people with Stroke, run by National Rehabilitation Center, Seoul, Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joon-Ho Shin, MS (82-2-901-1884, asfreelyas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2018.