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IRCT20250922067329N1 IRCT 2025-10-21 The University of Tehran Studying the effect of vibrating gloves on reducing symptoms of Parkinson's disease Empowering Parkinson's patients with vibrational Coordinated Reset method 2025-10-23 anticipated 6 Complete https://irct.ir/trial/86461 interventional Randomization: N/A, Blinding: Single blinded, Placebo: Used, Assignment: Crossover, Purpose: Supportive, Blinding description: Two gloves, one as a dummy glove with no effect and one as a real glove that affects the disease, are randomly provided to patients. During the study, two gloves are used for each patient, one of which is a sham, and the patient and the clinical caregiver do not know whether the dummy glove or the real glove was received first. 1-2 Idiopathic Parkinson’s. Intervention 1: Intervention group: A group of 3 patients who have been provided with the original gloves.Then, after a month of using the original glove, they receive the sham glove.We do not have a control group. Intervention 2: Intervention group: A group of 3 patients who are given sham gloves. Then after a month of using the sham gloves, they receive the original gloves. We do not have a control group. Yes - There is a plan to make this available What will be shared: Age, gender, and duration of Parkinson's disease will be included in a table in articles submitted to reputable international journals. The study protocol, statistical analysis plan, informed consent form, clinical study report, and codes used in the MATLAB environment will also be included in the article. When: After the articles are published, research information in most articles will be made available to experts and researchers. Approximately 9 months after the research To whom: The general public, researchers, and patients can use its information. Conditions: This research data can be used without preconditions for continued research in this field and for the use of researchers and physicians. Where to obtain: They can obtain the necessary information on the official website of the published articles. How to obtain: Go to the article publishing website and download it or email the research manager and receive the required information. Comments:
public Aboozar Moradi
No. 1, 5th Floor, Block 9, Shahid Chamran Residential Complex, Nobonyad Square, Tehran, Iran
Tehran Iran (Islamic Republic of) 1957978198 +98 21 2610 1508 amoradi1981@ut.ac.ir The University of Tehran scientific Aboozar Moradi
No. 1, 5th Floor, Block 9, Shahid Chamran Residential Complex, Nobonyad Square, Tehran, Iran
Tehran Iran (Islamic Republic of) 1957978198 +98 21 2610 1508 amoradi1981@ut.ac.ir The University of Tehran Iran (Islamic Republic of) Patients participating in this trial are between 45 and 85 years old. While taking the medication, Parkinson's disease was diagnosed with Hoehn and Yahr stage 2 to 4 criteria. Patients must communicate clearly with staff and speak Persian. 45 years 85 years Both Patients cannot have dopamine dis regulation syndrome or the presence of other neurological diseases such as major depression, dementia, attention deficit disorder, psychosis, or essential tremor. Patients cannot have a history of epilepsy, traumatic brain injury, or brain surgery. Patients cannot have severe sensory abnormalities of the fingertips, such as vibratory urticaria. They were excluded from the study if they were currently using psychotropic or narcotic medications or taking medications that affect brain function that would alter recorded EEG activity (such as anticonvulsant, ADHD, depression, or anxiety medications). Patients who are pregnant, lactating, or trying to become pregnant during the study period will be excluded from the study. Also, according to the selected TUG task, patients should not have a history of multiple sclerosis (MS), Alzheimer's, hip fracture, total knee or hip replacement surgery, Huntington's disease, and a history of stroke. G20 Parkinson's disease Rehabilitation Rehabilitation Intervention group: A group of 3 patients who have been provided with the original gloves.Then, after a month of using the original glove, they receive the sham glove.We do not have a control group. Intervention group: A group of 3 patients who are given sham gloves. Then after a month of using the sham gloves, they receive the original gloves. We do not have a control group. EEG connectivity. Timepoint: We have an EEG data acquisition as initial data from the patient, 14 days later the glove is delivered and data is collected on the same day, the next day-15th day data is collected to examine the short-term effect, then 2 weeks later, 14 days after delivery, we will have another data collection session, and finally 30 days after delivery, we will have another session. Then the Sham glove will be delivered and 3 data collection sessions will be taken in the first month, the middle of the month, and the end of the month, which will ultimately have 8 data collection sessions. Method of measurement: EEG data acquisition is performed with the help of a portable device at the National Brain Mapping Laboratory. For each patient, two weeks before the start of the study, a 10-minute EEG is taken during a standard cognitive TUG task with a vibrating glove.Then, after two weeks, data collection is repeated. First, 10 minutes without stimulation are taken before data collection, and then the glove is worn by the patient and 10 minutes of EEG data collection is performed with the vibrating glove stimulation during the TUG task. Then, data is collected from the patient again for 10 minutes without gloves during the TUG task. This will be a data collection session.The next day, data collection is also collected in the same way. Then the glove will be provided to the patient. Then, 2 weeks after the glove is delivered, we will have an EEG data collection session on the same day. Finally, we will have a data collection session 2 weeks later. In this way, in the first month, we will have 4 half-hour EEG data collection sessions from the patient. Then, we perform the same procedure in the second month with the Sham glove, which will be a total of 9 sessions in 2 months and 2 weeks, collecting data from the patient. UPDRS-III. Timepoint: Before each EEG session, the patient's ,UPDRS-III is taken once, for a total of 8 times. Method of measurement: This variable is taken by a neurologist - the project consultant - from patients in the neurology clinic of Hazrat Rasool Akram Hospital. PDQ-39 Questionnaire. Timepoint: Each time the UPDRS-III is taken from patients, the questionnaire will be filled out once. In total, we will have 7 questionnaires from patients. Method of measurement: The patient sits next to the researcher and answers the questions, which the researcher records on a response sheet. This is a standardized form validated by Oxford University. Comparison of EEG connectivity before and after using with gloves. Timepoint: Once the data is collected, a meaningful comparison analysis is performed. Method of measurement: By comparing the brain connectivity matrix before and after the intervention, connectivity should be reduced on average. Comparison of UPDRS-III score before and after intervention with effect size criterion and t-test statistical test. Timepoint: Once after data collection, every 7 data collection times are examined with the pre-intervention state for these statistical criteria. Method of measurement: The UPDRS-III score before and after the intervention is examined using t-test and Anova-test statistical tests to determine the effect size of the intervention. Comparison of PDQ-39 scores before and after intervention using t-test and Anova-test statistical tests. Timepoint: Once after data collection, every 7 data collection times are examined with the pre-intervention state for these statistical criteria. Method of measurement: The PDQ-39 score before and after the intervention is examined using t-test and Anova-test statistical tests to determine the effect size of the intervention. The University of Tehran Approved 2025-09-03 Research Ethics Committees of Iran University of Medical Sciences Department of Research and Technology Central Headquarters Building Iran University of Medical Sciences Adjacent to Milad Tower,Hemmat Highway Tehran,Iran Tehran Tehran Iran (Islamic Republic of)