StrokeNCT02592759
Effects of Upper Extremity Rehabilitation Using Smart Glove in Stroke Patients
A study testing Smart Glove Treatment in people with Stroke and Hemiplegia, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the therapeutic effects of smart glove which is motion-based program designed for upper extremity rehabilitation after stroke. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Stroke, Hemiplegia
- What is being tested?
- Smart Glove Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2015to Dec 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CT or MRI proved 1st stroke patients with unilateral hemiplegia caused by stroke (ischemic, hemorrhagic, intracranial hemorrhage)
- 72 hours ~ 3 months after stroke
- Upper extremity hemiplegia with Brunnström stage 2-5.
- The patients can sit to receive treatment for at least 1 hour
Who cannot join
- The patients cannot perform occupational treatments because of severe hemineglect or hemianopia
- Contracture due to severe limitation of motion
- Upper extremity spasticity in the wrist and fingers with modified Ashworth scale > 2 points
- Fugl-Meyer Assessment-Wrist \& Hand score >= 21 points
- moderate to severe cognitive dysfunction < MMSE 18 points
- Severe aphasia
- The patients who has been diagnosed as malignant tumor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Upper Extremity Rehabilitation Using Smart Glove in Stroke
The purpose of this study is to evaluate the therapeutic effects of smart glove which is motion-based program designed for upper extremity rehabilitation after stroke.
Read the detailed description
This study will evaluate the therapeutic effects (upper extremity power, function and activity of daily living) of smart glove which is motion-based rehabilitation program.
- Conditions
- Stroke, Hemiplegia
- Being tested
- Smart Glove Treatment
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart Glove TreatmentDevice
Smart glove is digital motion-based treatment device for stroke rehabilitation. The stroke patients wear this glove and hand motion is displayed on the computer monitor. They play games with this glove and are motivated to rehabilitation treatment because of fun.
| Study group | Role | What they receive |
|---|---|---|
| Smart Glove Group | Experimental | The subjects will be treated with conventional occupational therapy for 30 minutes and smart glove treatment for 30 minutes. 5 treatments per week will be conducted a total of 2 weeks. Receives: Device: Smart Glove Treatment |
| Homework group | No intervention | The subjects will be treated with conventional occupational therapy for 30 minutes and upper extremity rehabilitation homework which means the self training at bedside, for 30 minutes. 5 treatments per week will be conducted a total of 2 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment of Upper Extremity change
Evaluation tool for upper extremity function
Measured: Change from baseline points at 2 weeks and 6 weeks
Secondary outcomes (6)
Brunnström stage change
Evaluation tool for recovery
Measured: Change from baseline stage at 2 weeks and 6 weeks
Modified Barthel Index change
Evaluation tool for the level of active daily living
Measured: Change from baseline points at 2 weeks and 6 weeks
Care Burden Scale change
Evaluation tool to measure the care burden
Measured: Change from baseline points at 2 weeks and 6 weeks
Hand power change
Hand power using hand-held dynamometer
Measured: Change from baseline power at 2 weeks and 6 weeks
Jebsen Hand function Test change
Evaluation tool for upper extremity function
Measured: Change from baseline points at 2 weeks and 6 weeks
Box and Block Test change
Evaluation tool for upper extremity function
Measured: Change from baseline points at 2 weeks and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2018
- Study completionDec 2018
Why it stopped: The trial was prematurely terminated due to slow recruitment.
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.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center
- Responsible party
- Principal investigator, Shi-Uk Lee, Seoul National University Hospital
- Investigators
- Shi-Uk Lee, MD, PhD, Principal investigator, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02592759
- Sponsor's protocol ID
- 16-2015-74
- Status last verified
- Sep 2019
- First submitted
- 22 Oct 2015
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kang MG, Yun SJ, Lee SY, Oh BM, Lee HH, Lee SU, Seo HG. Effects of Upper-Extremity Rehabilitation Using Smart Glove in Patients With Subacute Stroke: Results of a Prematurely Terminated Multicenter Randomized Controlled Trial. Front Neurol. 2020 Nov 9;11:580393. doi: 10.3389/fneur.2020.580393. eCollection 2020.
PubMed 33240205
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Upper Extremity Rehabilitation Using Smart Glove in Stroke
- ClinicalTrials.gov ID
- NCT02592759
- Acronym / sponsor ID
- 16-2015-74
- Conditions
- Stroke, Hemiplegia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial was prematurely terminated due to slow recruitment.
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center
- Study start
- Oct 2015
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 30 Oct 2015 (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 this study is to evaluate the therapeutic effects of smart glove which is motion-based program designed for upper extremity rehabilitation after stroke.
Detailed description
This study will evaluate the therapeutic effects (upper extremity power, function and activity of daily living) of smart glove which is motion-based rehabilitation program.
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 Group | Experimental | Device: Smart Glove TreatmentThe subjects will be treated with conventional occupational therapy for 30 minutes and smart glove treatment for 30 minutes. 5 treatments per week will be conducted a total of 2 weeks. |
| Homework group | No intervention | –The subjects will be treated with conventional occupational therapy for 30 minutes and upper extremity rehabilitation homework which means the self training at bedside, for 30 minutes. 5 treatments per week will be conducted a total of 2 weeks. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- CT or MRI proved 1st stroke patients with unilateral hemiplegia caused by stroke (ischemic, hemorrhagic, intracranial hemorrhage)
- 72 hours ~ 3 months after stroke
- Upper extremity hemiplegia with Brunnström stage 2-5.
- The patients can sit to receive treatment for at least 1 hour
Key exclusion criteria (7 listed)
- The patients cannot perform occupational treatments because of severe hemineglect or hemianopia
- Contracture due to severe limitation of motion
- Upper extremity spasticity in the wrist and fingers with modified Ashworth scale > 2 points
- Fugl-Meyer Assessment-Wrist \& Hand score >= 21 points
- moderate to severe cognitive dysfunction < MMSE 18 points
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 TreatmentSmart glove is digital motion-based treatment device for stroke rehabilitation. The stroke patients wear this glove and hand motion is displayed on the computer monitor. They play games with this glove and are motivated to rehabilitation treatment because of fun. | Device | Smart Glove Group |
Primary outcome
Fugl-Meyer Assessment of Upper Extremity change
Time frame: Change from baseline points at 2 weeks and 6 weeks
Evaluation tool for upper extremity function
6 secondary outcomes
Brunnström stage change
Time frame: Change from baseline stage at 2 weeks and 6 weeks
Modified Barthel Index change
Time frame: Change from baseline points at 2 weeks and 6 weeks
Care Burden Scale change
Time frame: Change from baseline points at 2 weeks and 6 weeks
Hand power change
Time frame: Change from baseline power at 2 weeks and 6 weeks
Jebsen Hand function Test change
Time frame: Change from baseline points at 2 weeks and 6 weeks
Box and Block Test change
Time frame: Change from baseline points at 2 weeks and 6 weeks
Results and safety
The study was stopped early (reason given: The trial was prematurely terminated due to slow recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
- Derived from this study: PubMed 33240205Kang MG, Yun SJ, Lee SY, Oh BM, Lee HH, Lee SU, Seo HG. Effects of Upper-Extremity Rehabilitation Using Smart Glove in Patients With Subacute Stroke: Results of a Prematurely Terminated Multicenter Randomized Controlled Trial. Front Neurol. 2020 Nov 9;11:580393. doi: 10.3389/fneur.2020.580393. eCollection 2020.
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Shi-Uk Lee, MD, PhD principal investigator
SMG-SNU Boramae Medical 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 Treatment in people with Stroke and Hemiplegia, run by Seoul National University Hospital 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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 1 Oct 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. 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?
The study was stopped early (reason given: The trial was prematurely terminated due to slow recruitment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment of Upper Extremity change (time frame: Change from baseline points at 2 weeks and 6 weeks). 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 NCT02592759, 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 1 Oct 2019.