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IRCT20190812044516N2 IRCT 2023-03-07 Shahid Beheshti University of Medical Sciences Effects of high-amplitude intense exercises in patients with Parkinson Effects of high-amplitude intense exercises with the Silverman-voice therapy on the bradykinesia of patients with Parkinson 2023-04-03 anticipated 32 Complete https://irct.ir/trial/68903 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: we use block randomization to allocate participants to the groups with an equal sample size over time. The groups will labeled (E= experimental, C= control). Then a block size of four will chose.So, there were six possible ways to equally assign participants to a block (EECC, ECEC, ECCE, CEEC, CECE, CCEE). Blocks were randomly chosen to determine the assignment of all 32 individuals (16 participants in each group). Allocation concealment is performed using sealed, opaque envelopes, Blinding description: Participants in the study do not know which group they are in. The assessment of patients before and after the intervention will be done by another physiotherapist who is not aware of the study procedure. N/A Parkinson’s disease. Intervention 1: Intervention group: The participants in the intervention group will perform general physical therapy exercises (including stretching and strengthening exercises) along with the Lee Silverman Standard Method exercise program, which includes high-amplitude, high-intensity exercises. The intervention program will be 4 days a week for 4 weeks and a total of 16 one-hour sessions. Intervention 2: Control group: The participants in the control group will perform general physical therapy exercises (including stretching and strengthening exercises).The intervention program will be 4 days a week for 4 weeks and a total of 16 one-hour sessions. Yes - There is a plan to make this available What will be shared: Information on the main outcome is shared When: Six months after the publication of the results To whom: Researchers in academic and scientific institutions Conditions: In order to study Where to obtain: E-mail address of Nahid Tahan nahidta2431@gmail.com How to obtain: Request by sending to the respondent's email Comments:
public Nahid Tahan
Damavand Ave., Imam Hossein Sq., Tehran,
Tehran Iran (Islamic Republic of) 1616913111 +98 21 7756 1723 nahidta2431@gmail.com Shahid Beheshti University of Medical Sciences scientific Nahid Tahan
Damavand Ave., Imam Hossein Sq., Tehran
Tehran Iran (Islamic Republic of) 1616913111 +98 21 7756 1724 nahidta2431@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Diagnosed as Idiopathic Parkinson stable medication 4 weeks prior to inclusion Being able to walk for 6 m with or without aids 40 years 80 years Both Severe depression Any medical or musculoskeletal contraindications to exercise G20 Parkinson's disease Rehabilitation Rehabilitation Intervention group: The participants in the intervention group will perform general physical therapy exercises (including stretching and strengthening exercises) along with the Lee Silverman Standard Method exercise program, which includes high-amplitude, high-intensity exercises. The intervention program will be 4 days a week for 4 weeks and a total of 16 one-hour sessions Control group: The participants in the control group will perform general physical therapy exercises (including stretching and strengthening exercises).The intervention program will be 4 days a week for 4 weeks and a total of 16 one-hour sessions Motor TUG test. Timepoint: Before the intervention and one month after the start of the intervention. Method of measurement: Time duration of test in second. Cognitive TUG test. Timepoint: Before the intervention and one month after the start of the intervention. Method of measurement: Time duration of test in second. Montreal Cognitive Assessment. Timepoint: Before the intervention and one month after the start of the intervention. Method of measurement: The score of test. Shahid Mehehsti university of medical Sciences Approved 2023-01-01 Ethics committee of shahid behehsti university of medical sciences No.15, Yaman St, Arabi St, Next to Taleghani Hospital, Chamran High way, Tehran Tehran Iran (Islamic Republic of)