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IRCT20211008052695N1 IRCT 2021-11-17 Ahvaz University of Medical Sciences Evaluation of Atomoxetine efficacy on Freezing of gait in patient with Parkinson Evaluation of Atomoxetine efficacy on Freezing of gait in patient with Parkinson 2021-09-23 anticipated 32 Complete https://irct.ir/trial/59643 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study is a randomized controlled clinical trial. In this study, patients will be assigned to each treatment group using a randomized block method using four blocks in this study. Blocking is used to balance the number of samples assigned to each of the study groups. This feature helps to equate the number of samples assigned to each of the study groups in cases where intermediate analyzes are required during the sampling process. The blinding method will also be used to prevent the allocation from being disclosed in each block. This study will be double-blind. The correction will be performed by recording atomoxetine and placebo by a person who has no information about the patient group. A total of 32 patients of both sexes and all age groups were randomly selected from Parkinson's patients referred to Ahvaz Golestan Hospital in 6 months in 1400 who had frozen gait and were treated with levodopa. Hoehn and yahr scale divisions in groups 2 to 4 will be included in the study. Group A consists of 16 patients randomly selected by an uninformed person and treated with atomoxetine 40 mg for two weeks and then increased the dose to 80 mg for six weeks. Group B consists of 16 patients who are randomly selected by an uninformed person and are treated with a placebo similar to group A. The first visit will be on the first day before starting treatment and determining the score of the FOGQ questionnaire and starting the medication. This questionnaire consists of 6 questions, each of which receives a score of 0 to 4, and the minimum score is 0, and the maximum is 24. The second visit will take place two weeks after treatment, and the third visit will take place six weeks after the second visit. The score of the FOGQ questionnaire will be prepared from the patient, and finally, the data will be analyzed by SPSS statistical software version 22. The FOGQ questionnaire is a questionnaire that assesses the freezing of gait in Parkinson's patients. Giladi introduced this questionnaire in 1999. Giladi calculated the validity and reliability of this questionnaire on 40 patients with Parkinson's disease. Using Cronbach's alpha, 94% was obtained, and the validity rate for this questionnaire was 70% (Giladi article reference). In Iran, this questionnaire was translated by Taghizadeh in 2021. He used the questionnaire for 115 patients with Parkinson's disease. Cronbach's alpha was 92% (Taghizadeh article), Blinding description: Blinding will be done by recording atomoxetine and placebo by a person who has no information about the patient group. A total of 32 patients of both sexes and all age groups were randomly selected from Parkinson's patients referred to Ahvaz Golestan Hospital in a period of 6 months in 1400 who had frozen gait and were treated with levodopa. The Hoehn and yahr scale divisions in categories 2 to 4 will be included in the study. 3 Parkinson disease. Intervention 1: Intervention group: Group A includes 16 patients randomly selected by an uninformed person and treated with atomoxetine 40 mg for 2 weeks and then increase the dose to 80 mg for six weeks. Intervention 2: Control group: Group B includes 16 patients who are randomly selected by an uninformed person and are treated with a placebo similar to group A. Yes - There is a plan to make this available What will be shared: After the analysis, the study results are presented to all study participants in the form of a file. When: Start of the access period from the end of 1400 for 6 months after the end of printing the results To whom: Researchers and participants Conditions: Access to the data is not an obstacle if the participants' personal details are distorted. Where to obtain: Responsible person - 09163439107 How to obtain: Contact the project manager - review the application - register and submit Comments:
public Seyed Ehsan Mohamadianinejad
Farvardin Ave., Golestan Hospital., Golestan
Ahwaz Iran (Islamic Republic of) 6136763316 +98 61 3320 4531 D.R.ramezanirad@gmail.com Ahvaz University of Medical Sciences scientific Seyed Ehsan Mohamadianinejad
Farvardin Ave., Golestan Hospital., Golestan
Ahwaz Iran (Islamic Republic of) 6136763316 +98 61 3441 0975 D.R.ramezanirad@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) 1) Diagnosis of Parkinson's disease based on examination and history 2) Patients with stage 2-4 of Hoehn and yahr scale; 3) Normal tests (vitamin B12, thyroid, liver, and kidney tests) 4) Levodopa treatment for at least 3 months before the study 5) Ability to walk at least 20 steps without the use of assistive devices no limit no limit Both G21.9 Secondary parkinsonism, unspecified Treatment - Drugs Treatment - Drugs Intervention group: Group A includes 16 patients randomly selected by an uninformed person and treated with atomoxetine 40 mg for 2 weeks and then increase the dose to 80 mg for six weeks. Control group: Group B includes 16 patients who are randomly selected by an uninformed person and are treated with a placebo similar to group A. Freezing of gait in patient with Parkinson. Timepoint: Patients are treated with atomoxetine at a dose of 40 mg for 2 weeks and then increase the dose to 80 mg for six weeks. Method of measurement: The first visit will be on the first day and before starting treatment, determining the FOGQ questionnaire's score, and starting the medication. This questionnaire consists of 6 questions, each of which receives a score of 0 to 4, and the minimum score is 0, and the maximum is 24. The second visit will take place two weeks after the start of treatment, and the third visit will take place 6 weeks after the second visit. Ahvaz University of Medical Sciences Approved 2021-04-13 Research Ethics Committees of Golestan Hospital No. 9, 9 Resalat Ave., NIDC Complex ahwaz Khouzestan Iran (Islamic Republic of)