StrokeNCT04055597
Effects of Upper Extremity Rehabilitation Robot and Transcranial Direct Current Stimulation Among Patients With Stroke
A study testing Robot and tDCS on-line in people with Stroke, run by National Rehabilitation Center, Seoul, Korea at 1 site in South Korea.
Trial summary
Effects of upper extremity rehabilitation robot and transcranial direct current stimulation on upper extremity function among subjects with tremor after stroke Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Robot and tDCS on-line
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2017to 31 Dec 2019
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stroke with cerebellar hemorrhage or infarction
- ataxia or tremor on upper extremities secondary to stroke
- Cognitively intact enough to understand and follow the instructions from the investigator
Who cannot join
- History of surgery of affected upper limb
- Fracture of affected upper limb
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: Effects of Upper Extremity Rehabilitation Robot and Transcranial Direct Current Stimulation on Upper Extremity Function Among Subjects With Tremor After Cerebellar and Brainstem Stroke
Effects of upper extremity rehabilitation robot and transcranial direct current stimulation on upper extremity function among subjects with tremor after stroke
- Conditions
- Stroke
- Being tested
- Robot and tDCS on-line, Robot and sham tDCS
- Keywords
- cerebellar stroke, upper extremity rehabilitation robot, transcranial direct current stimulation, 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.
Robot and tDCS on-lineOther
Combined transcranial direct current stimulation(tDCS) on-line and upper extremity rehabilitation robot for 5 times a week for 4 weeks
Robot and sham tDCSOther
Combined sham tDCS and upper extremity rehabilitation robot for 5 times a week for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Robot and tDCS on-line | Experimental | Combined transcranial direct current stimulation(tDCS) on-line and upper extremity rehabilitation robot Receives: Other: Robot and tDCS on-line |
| Robot and sham tDCS | Sham comparator | Combined sham tDCS and upper extremity rehabilitation robot Receives: Other: Robot and sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Scale for the assessment and rating of ataxia
Change of Scale for the assessment and rating of ataxia
Measured: Change of Scale for the assessment and rating of ataxia at 4 weeks after baseline compared to baseline
Change of Functional ataxia rating scale - upper limb
Change of Functional ataxia rating scale - upper limb
Measured: Change of the Functional ataxia rating scale - upper limb, at 4 weeks after baseline compared to baseline
Secondary outcomes (16)
Fugl-Meyer Assessment - upper extremity
Fugl-Meyer Assessment - upper extremity
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Composite cerebellar functional severity score
Composite cerebellar functional severity score (Nine hole peg test + click test)
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Jerk during reaching and finger pointing
Kinematic data during reaching and finger pointing using Trakstar
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Smoothness during reaching and finger pointing
Kinematic data during reaching and finger pointing using Trakstar
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Behavioral activation system/behavioral inhibition system scale
In terms of motivation
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Beck's depression index
Beck's depression index
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Stroke rehabilitation motivation scale
Stroke rehabilitation motivation scale
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Intrinsic motivation inventory
Intrinsic motivation inventory
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Numeric rating scale for upper extremity pain
Question about the upper extremity pain (0-10; higher is better)
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Functional reaching test
Functional reaching test
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
modified Barthel index
modified Barthel index
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
% maximal voluntary contraction from upper extremity muscles during reaching task
data from surface electromyography from upper extremity muscles during reaching task
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Kinematic data during scale for the assessment and rating of ataxia
Kinematic data during scale for the assessment and rating of ataxia
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Scale for the assessment and rating of ataxia
Scale for the assessment and rating of ataxia
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Functional ataxia rating scale - upper limb
Functional ataxia rating scale - upper limb, kinematic data during scale for the assessment
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Kinematic data during scale during the Functional ataxia rating scale - upper limb
Kinematic data during scale during the Functional ataxia rating scale - upper limb
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start1 Jun 2017
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 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
- NCT04055597
- Sponsor's protocol ID
- NRC-2017-01-004
- Status last verified
- Aug 2019
- First submitted
- 1 Mar 2018
- Last updated
- 14 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Upper Extremity Rehabilitation Robot and Transcranial Direct Current Stimulation on Upper Extremity Function Among Subjects With Tremor After Cerebellar and Brainstem Stroke
- ClinicalTrials.gov ID
- NCT04055597
- Acronym / sponsor ID
- NRC-2017-01-004
- Conditions
- Stroke
- Keywords
- cerebellar stroke, upper extremity rehabilitation robot, transcranial direct current stimulation, stroke rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Rehabilitation Center, Seoul, KoreaOther government
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 14 Aug 2019 (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.
Effects of upper extremity rehabilitation robot and transcranial direct current stimulation on upper extremity function among subjects with tremor after stroke
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot and tDCS on-line | Experimental | Other: Robot and tDCS on-lineCombined transcranial direct current stimulation(tDCS) on-line and upper extremity rehabilitation robot |
| Robot and sham tDCS | Sham comparator | Other: Robot and sham tDCSCombined sham tDCS and upper extremity rehabilitation robot |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stroke with cerebellar hemorrhage or infarction
- ataxia or tremor on upper extremities secondary to stroke
- Cognitively intact enough to understand and follow the instructions from the investigator
Key exclusion criteria (2 listed)
- History of surgery of affected upper limb
- Fracture of affected upper limb
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 |
|---|---|---|
| Robot and tDCS on-lineCombined transcranial direct current stimulation(tDCS) on-line and upper extremity rehabilitation robot for 5 times a week for 4 weeks | Other | Robot and tDCS on-line |
| Robot and sham tDCSCombined sham tDCS and upper extremity rehabilitation robot for 5 times a week for 4 weeks | Other | Robot and sham tDCS |
Primary outcome
Change of Scale for the assessment and rating of ataxia
Time frame: Change of Scale for the assessment and rating of ataxia at 4 weeks after baseline compared to baseline
Change of Scale for the assessment and rating of ataxia
Change of Functional ataxia rating scale - upper limb
Time frame: Change of the Functional ataxia rating scale - upper limb, at 4 weeks after baseline compared to baseline
Change of Functional ataxia rating scale - upper limb
16 secondary outcomes
Fugl-Meyer Assessment - upper extremity
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Composite cerebellar functional severity score
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Jerk during reaching and finger pointing
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Smoothness during reaching and finger pointing
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Behavioral activation system/behavioral inhibition system scale
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Beck's depression index
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Stroke rehabilitation motivation scale
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Intrinsic motivation inventory
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Numeric rating scale for upper extremity pain
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Functional reaching test
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
modified Barthel index
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
% maximal voluntary contraction from upper extremity muscles during reaching task
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Kinematic data during scale for the assessment and rating of ataxia
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Scale for the assessment and rating of ataxia
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Functional ataxia rating scale - upper limb
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Kinematic data during scale during the Functional ataxia rating scale - upper limb
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
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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 Robot and tDCS on-line 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 3 inclusion and 2 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 Aug 2019. 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?
Change of Scale for the assessment and rating of ataxia (time frame: Change of Scale for the assessment and rating of ataxia at 4 weeks after baseline compared to baseline). The study lists 2 primary outcomes in all. 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 Aug 2019.