StrokeNCT02772510
Upper Extremity Rehabilitation Using Game Rehabilitation System With Functional Electrical Stimulation for Stroke Patients
A study testing Smart glove system with functional electrical stimulation and Functional electrical stimulation in people with Stroke, run by National Rehabilitation Center, Seoul, Korea at 1 site in South Korea.
Trial summary
The purpose of the present study was to investigate the effects of game-based virtual reality rehabilitation combined with functional electrical stimulation on distal upper extremity function, and compare the findings to those of functional electrical stimulation in stroke survivors. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Smart glove system with functional electrical stimulation and Functional electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2015to Oct 2016
- 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
- first-ever ischemic or hemorrhagic stroke
- wrist extensor of medical research council scale 1~3
- No clinical evidence of limited passive range of motion of affected wrist
Who cannot join
- age <18 years
- severe aphasia resulting in communication difficulties confounding intervention and outcome measures
- severe cognitive impairment resulting cooperation difficulties
- spasticity > modified Ashworth scale 1+
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
National Rehabilitation Center
Seoul, Seoul, 142884
Joon-Ho Shin, MS
Joon-Ho Shin, MS
About this study
Official title: Upper Extremity Rehabilitation Using Game-based Virtual Reality Rehabilitation System (Smart Glove System) With Functional Electrical Stimulation for Stroke Patients : Randomized Controlled Trial
The purpose of the present study was to investigate the effects of game-based virtual reality rehabilitation combined with functional electrical stimulation on distal upper extremity function, and compare the findings to those of functional electrical stimulation in stroke survivors.
- Conditions
- Stroke
- Being tested
- Smart glove system with functional electrical stimulation, Functional electrical stimulation
- Keywords
- Stroke, Rehabilitation, Hand, Game, Functional electrical stimulation, Virtual reality
- 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 functional electrical stimulationDevice
Game-based virtual reality rehabilitation system (Smart glove system) combined with functional electrical stimulation on distal upper extremity
Functional electrical stimulationDevice
Functional electrical stimulation on distal upper extremity
| Study group | Role | What they receive |
|---|---|---|
| Smart glove system with functional electrical stimulation | Experimental | game-based virtual reality rehabilitation combined with functional electrical stimulation for upper extremity Receives: Device: Smart glove system with functional electrical stimulation |
| Functional electrical stimulation | Active comparator | functional electrical stimulation on upper extremity Receives: Device: Functional electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wolf Motor Function Test
Measured: 4 weeks from baseline
Fugl-Meyer Assessment-hand & wrist
Measured: 4 weeks from baseline
Secondary outcomes (16)
Wolf Motor Function Test
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Box and Block Test
number of block transferred by hand from one box to other box.
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Fugl-Meyer Assessment upper extremity
global assessment of upper extremity impairment
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Stroke Impact Scale
Measured: baseline, 4 weeks after baseline
Motor Activity Log
Measured: baseline, 4 weeks after baseline
Medical research council scale of elbow flexion/extension
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Medical research council scale of wrist flexion/extension
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Range Of Motion of elbow flexion/extension
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Range Of Motion of wrist flexion/extension
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Brunnstrom stage
It represent the recovery status among stroke patients
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Jebsen-Taylor hand function test
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Modified Ashworth scale of elbow flexor/extension
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Modified Ashworth scale of wrist flexion/extension
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Modified Tardieu scale of elbow flexor/extension
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Modified Tardieu scale of wrist flexion/extension
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Adverse events
Any adverse events
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 posted13 May 2016 (estimated)
- Study startFeb 2015
- Primary completionOct 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Outcomes assessor
- Enrolment
- 54 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
- NCT02772510
- Sponsor's protocol ID
- NRC-2015-01-004
- Status last verified
- Oct 2016
- First submitted
- 8 May 2016
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lee SH, Lee JY, Kim MY, Jeon YJ, Kim S, Shin JH. Virtual Reality Rehabilitation With Functional Electrical Stimulation Improves Upper Extremity Function in Patients With Chronic Stroke: A Pilot Randomized Controlled Study. Arch Phys Med Rehabil. 2018 Aug;99(8):1447-1453.e1. doi: 10.1016/j.apmr.2018.01.030. Epub 2018 Mar 2.
PubMed 29505744
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upper Extremity Rehabilitation Using Game-based Virtual Reality Rehabilitation System (Smart Glove System) With Functional Electrical Stimulation for Stroke Patients : Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02772510
- Acronym / sponsor ID
- NRC-2015-01-004
- Conditions
- Stroke
- Keywords
- Stroke, Rehabilitation, Hand, Game, Functional electrical stimulation, Virtual reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- National Rehabilitation Center, Seoul, KoreaOther government
- Study start
- Feb 2015
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 13 May 2016 (estimated)
- 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 purpose of the present study was to investigate the effects of game-based virtual reality rehabilitation combined with functional electrical stimulation on distal upper extremity function, and compare the findings to those of functional electrical stimulation in stroke survivors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smart glove system with functional electrical stimulation | Experimental | Device: Smart glove system with functional electrical stimulationgame-based virtual reality rehabilitation combined with functional electrical stimulation for upper extremity |
| Functional electrical stimulation | Active comparator | Device: Functional electrical stimulationfunctional electrical stimulation on upper extremity |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- first-ever ischemic or hemorrhagic stroke
- wrist extensor of medical research council scale 1~3
- No clinical evidence of limited passive range of motion of affected wrist
Key exclusion criteria (4 listed)
- age <18 years
- severe aphasia resulting in communication difficulties confounding intervention and outcome measures
- severe cognitive impairment resulting cooperation difficulties
- spasticity > modified Ashworth scale 1+
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 functional electrical stimulationGame-based virtual reality rehabilitation system (Smart glove system) combined with functional electrical stimulation on distal upper extremity | Device | Smart glove system with functional electrical stimulation |
| Functional electrical stimulationFunctional electrical stimulation on distal upper extremity | Device | Functional electrical stimulation |
Primary outcome
Wolf Motor Function Test
Time frame: 4 weeks from baseline
Fugl-Meyer Assessment-hand & wrist
Time frame: 4 weeks from baseline
16 secondary outcomes
Wolf Motor Function Test
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Box and Block Test
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Fugl-Meyer Assessment upper extremity
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Stroke Impact Scale
Time frame: baseline, 4 weeks after baseline
Motor Activity Log
Time frame: baseline, 4 weeks after baseline
Medical research council scale of elbow flexion/extension
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Medical research council scale of wrist flexion/extension
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Range Of Motion of elbow flexion/extension
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Range Of Motion of wrist flexion/extension
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Brunnstrom stage
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Jebsen-Taylor hand function test
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Modified Ashworth scale of elbow flexor/extension
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Modified Ashworth scale of wrist flexion/extension
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Modified Tardieu scale of elbow flexor/extension
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Modified Tardieu scale of wrist flexion/extension
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Adverse events
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 25 Oct 2016.
- Derived from this study: PubMed 29505744Lee SH, Lee JY, Kim MY, Jeon YJ, Kim S, Shin JH. Virtual Reality Rehabilitation With Functional Electrical Stimulation Improves Upper Extremity Function in Patients With Chronic Stroke: A Pilot Randomized Controlled Study. Arch Phys Med Rehabil. 2018 Aug;99(8):1447-1453.e1. doi: 10.1016/j.apmr.2018.01.030. Epub 2018 Mar 2.
- Individual participant dataSharing planned: No
Related trials for Stroke
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
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 functional electrical stimulation and Functional electrical stimulation 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 4 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 25 Oct 2016. 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. 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?
Wolf Motor Function Test (time frame: 4 weeks from 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?
On the ClinicalTrials.gov record for NCT02772510, which also lists 1 linked publication.
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 25 Oct 2016.