- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05743296
Differences in Brain Activity in the Application of Upper Limb Exercise Tasks Through Virtual Reality
February 27, 2023 updated by: Samsung Medical Center
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
25
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of, 06351
- Samsung Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Stroke patients
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Cross-sectional study, no arm
Experimental: Training with the virtual reality program (MOTOCOG) Training consists of 26 minutes task-specific training. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Fugl-Meyer Assessment Upper Extremity
Time Frame: Baseline
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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.
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Grip and Tip pinch strength test
Time Frame: Baseline
|
The test is to measure the maximum isometric strength of hand, forearm, and finger muscles.
|
Baseline
|
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Box & Block Test
Time Frame: Baseline
|
The test is used to measure the gross manual dexterity of a patient, or of a person using an upper limb prosthetic device.
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Baseline
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9-hole pegboard test
Time Frame: Baseline
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The test is a standardized, quantitative assessment used to measure finger dexterity of a patient.
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Baseline
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Jebsen-Taylor Hand Function test
Time Frame: Baseline
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This test is a standardized and objective measure of fine and gross motor hand function using simulated activities of daily living (ADL).
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Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 27, 2022
Primary Completion (Actual)
February 20, 2023
Study Completion (Actual)
February 20, 2023
Study Registration Dates
First Submitted
December 22, 2022
First Submitted That Met QC Criteria
February 20, 2023
First Posted (Actual)
February 24, 2023
Study Record Updates
Last Update Posted (Actual)
March 1, 2023
Last Update Submitted That Met QC Criteria
February 27, 2023
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-10-117
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.