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IRCT20230226057541N1 IRCT 2023-10-17 Mashhad University of Medical Sciences Investigating the effectiveness of biofeedback on reducing hand tremors in Parkinson's patients Investigating the effectiveness of biofeedback exercise on reducing hand tremors in Parkinson's patients 2023-11-06 anticipated 18 Complete https://irct.ir/trial/68847 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Cluster randomization using Excel software; to assign the participants to each of the intervention and sham groups, we use the rand and rank functions in Excel software. By using these functions, half of the participating population is selected for the intervention group and the other half is assigned to the sham group, Blinding description: The clinical trial will be done in a triple-blind way. 1- The person who divides the patient into two groups is one of those interventions that does not identify the patients. The list of patients is divided into two intervention and sham groups by random selection in Excel. 2- It is clear whether they are in the intervention or sham group. 3- All the recorded data are analyzed, and it is determined whether it belongs to the intervention or sham group. Patients are divided into two groups by random selection of Excel software, and each person is assigned a code, and data analysis is performed for each code, and the analyst is completely blinded to the patients. N/A Parkinson. Intervention 1: Intervention group: 10 sessions of biofeedback training to control hand tremors. Intervention 2: Control group: trying to control the hand tremor, by holding the device in turned-off mode in 10 sessions. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Hamidreza Kobravi
Biomedical Engineering Department, 1st floor, Engineering Building, Ostad Yusofi Street, Emamieh Boulevard ,GhasemAbad
Mashhad Iran (Islamic Republic of) 9187147578 +98 51 3729 8358 hamidrezakobravi@gmail.com Islamic Azad University scientific Ali Shoeibi
Ghaem Hospital, Ahmadabad Avenue
mashhad Iran (Islamic Republic of) 9919991766 +98 51 3840 0001 shoeibia@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Diagnosis of Parkinson's disease based on UPDRS criteria rest tremor in at least one hand Absence of mood disorders (depression or anxiety disorder) Informed consent 20 years no limit Both Severe disability that prevents the patient from cooperating in the trial Symptoms of neuropathy and other neurological disorders affecting feedback G520 Parkinson disease Rehabilitation Rehabilitation Intervention group: 10 sessions of biofeedback training to control hand tremors Control group: trying to control the hand tremor, by holding the device in turned-off mode in 10 sessions Postural tremor of hands. Timepoint: Before starting interventions, after completing interventions, follow-up session. Method of measurement: Based on movement disorder society-sponsored revision of the unified Parkinson’s disease rating scale (MDS-UPDRS). Kinetic tremor of hands. Timepoint: Before starting interventions, after completing interventions, follow-up session. Method of measurement: Based on movement disorder society-sponsored revision of the unified Parkinson’s disease rating scale (MDS-UPDRS). Rest tremor amplitude. Timepoint: Before starting interventions, after completing interventions, follow-up session. Method of measurement: Based on movement disorder society-sponsored revision of the unified Parkinson’s disease rating scale (MDS-UPDRS). Constancy of rest tremor. Timepoint: Before starting interventions, after completing interventions, follow-up session. Method of measurement: Based on movement disorder society-sponsored revision of the unified Parkinson’s disease rating scale (MDS-UPDRS). Characteristics of hand tremor accelerometer. Timepoint: During training with the device. Method of measurement: Using an accelerometer. Quality of life scale in Parkinson's disease PDQ-39. Timepoint: Before starting interventions, after completing interventions, follow-up session. Method of measurement: Quality of life in Parkinson's disease PDQ-39 Questionnaire. Mashhad University of Medical Sciences Approved 2023-07-18 Ethics committee of Mashhad University of Medical Sciences Ghoreshi Building, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)