StrokeNCT05743296
Differences in Brain Activity in the Application of Upper Limb Exercise Tasks Through Virtual Reality
An observational study of Stroke, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This study aims to find out the difference in brain activity when performing upper limb exercise tasks through virtual reality-based MOTOCOG equipment for chronic stroke patients. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Stroke
- How many people
- 25 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Dec 2022to 20 Feb 2023
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stroke patients
Who may be able to join
- Patients aged 19 to 80 years
- FMA Upper scores more than 25 and less than 58
- Patients whose lesions do not include stimulation regions
- Patients with stroke with more than 6 months of onset
- K-MMSE scores more than 24
- patients who can Grasp \& release
Who cannot join
- Difficult to communicate due to severe language impairment.
- Accompanied by an existing serious neurogenic disease
- Existing significant psychiatric disorders such as major schizophrenia, bipolar disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Differences in Brain Activity in the Application of Upper Limb Exercise Tasks Through Virtual Reality in Chronic Stroke Patients
This study aims to find out the difference in brain activity when performing upper limb exercise tasks through virtual reality-based MOTOCOG equipment for chronic stroke patients.
Read the detailed description
This study aims to find out the difference in brain activity when performing upper limb exercise tasks through virtual reality-based MOTOCOG equipment for chronic stroke patients. All participants will participate in tasks for upper limb exercise conducted for 26 minutes.
- Conditions
- Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cross-sectional study, no arm | Experimental: Training with the virtual reality program (MOTOCOG) Training consists of 26 minutes task-specific training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment Upper Extremity
Measurement of motor function of upper and lower extremities. The minimum and maximum values are 0 and 66, and higher scores mean a better outcome.
Measured: Baseline
Secondary outcomes (4)
Grip and Tip pinch strength test
The test is to measure the maximum isometric strength of hand, forearm, and finger muscles.
Measured: Baseline
Box & Block Test
The test is used to measure the gross manual dexterity of a patient, or of a person using an upper limb prosthetic device.
Measured: Baseline
9-hole pegboard test
The test is a standardized, quantitative assessment used to measure finger dexterity of a patient.
Measured: Baseline
Jebsen-Taylor Hand Function test
This test is a standardized and objective measure of fine and gross motor hand function using simulated activities of daily living (ADL).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start27 Dec 2022
- Primary completion20 Feb 2023
- Study completion20 Feb 2023
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 Samsung Medical CenterThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05743296
- Sponsor's protocol ID
- 2022-10-117
- Status last verified
- Nov 2022
- First submitted
- 22 Dec 2022
- Last updated
- 1 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim J, Kim E, Lee SH, Lee G, Kim YH. Use of cortical hemodynamic responses in digital therapeutics for upper limb rehabilitation in patients with stroke. J Neuroeng Rehabil. 2024 Jul 10;21(1):115. doi: 10.1186/s12984-024-01404-y.
PubMed 38987817
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences in Brain Activity in the Application of Upper Limb Exercise Tasks Through Virtual Reality in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT05743296
- Acronym / sponsor ID
- 2022-10-117
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 27 Dec 2022 (actual)
- Primary completion
- 20 Feb 2023 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 24 Feb 2023 (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.
This study aims to find out the difference in brain activity when performing upper limb exercise tasks through virtual reality-based MOTOCOG equipment for chronic stroke patients.
Detailed description
This study aims to find out the difference in brain activity when performing upper limb exercise tasks through virtual reality-based MOTOCOG equipment for chronic stroke patients. All participants will participate in tasks for upper limb exercise conducted for 26 minutes.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cross-sectional study, no arm | – | –Experimental: Training with the virtual reality program (MOTOCOG) Training consists of 26 minutes task-specific training. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke patients
Key inclusion criteria (6 listed)
- Patients aged 19 to 80 years
- FMA Upper scores more than 25 and less than 58
- Patients whose lesions do not include stimulation regions
- Patients with stroke with more than 6 months of onset
- K-MMSE scores more than 24
Key exclusion criteria (3 listed)
- Difficult to communicate due to severe language impairment.
- Accompanied by an existing serious neurogenic disease
- Existing significant psychiatric disorders such as major schizophrenia, bipolar disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fugl-Meyer Assessment Upper Extremity
Time frame: Baseline
Measurement of motor function of upper and lower extremities. The minimum and maximum values are 0 and 66, and higher scores mean a better outcome.
4 secondary outcomes
Grip and Tip pinch strength test
Time frame: Baseline
Box & Block Test
Time frame: Baseline
9-hole pegboard test
Time frame: Baseline
Jebsen-Taylor Hand Function test
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Derived from this study: PubMed 38987817Kim J, Kim E, Lee SH, Lee G, Kim YH. Use of cortical hemodynamic responses in digital therapeutics for upper limb rehabilitation in patients with stroke. J Neuroeng Rehabil. 2024 Jul 10;21(1):115. doi: 10.1186/s12984-024-01404-y.
Related trials for Stroke
Not yet recruiting
Foot Drop Rehabilitation and Mobility in Chronic Stroke
Stroke
Enrolling by invitation
Study on the Efficacy and Safety of Non-Invasive Brain-Computer Interface With MRI-Guided Multi-Channel Time-Domain Interference Stimulation in Treating Motor Dysfunction in Acute Cerebral Infarction Patients
Acute Ichemic Stroke
RecruitingObservational study
Development, Validation and Normative Data of the Italian Battery for the Recognition of Famous Faces (FAME)
Stroke, Alzheimer s Disease
Enrolling by invitation
Long-Term Clinical, Health Economic, and Process Evaluation of Intensive Technology-Integrated Motor Rehabilitation in Chronic Neurological Conditions (INTeRAcT-bis)
Stroke, Spinal Cord Injuries (SCI)
Not yet recruitingPhase 2
Rimonabant for Improving Walking Ability in Patients With Chronic Stroke
Chronic Stroke
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Samsung Medical Center 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 6 inclusion and 3 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: finished, as of the sponsor's last update on 1 Mar 2023. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Upper Extremity (time frame: Baseline). 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 NCT05743296, 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 Mar 2023.