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IRCT20170725035278N3 IRCT 2021-03-07 Babol University of Medical Sciences The effect of intensive rehabilitation treatment protocol-based occupational therapy on freezing of gait, psychological symptoms, and quality of life in Parkinson's elderly The effect of intensive rehabilitation treatment protocol-based occupational therapy on freezing of gait, psychological symptoms, and quality of life in Parkinson's elderly 2021-02-19 anticipated 64 Complete https://irct.ir/trial/53614 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: the method of allocation of subjects after applying the entry and exit criteria is randomly allocated to the block method . the unit of randomization is individual . the size of blocks may be high and each block is repeated twice . then , using the software soft ware " s software , the sequencing is generated . using this list , which is randomly generated , participants are assigned to one of the two groups . in order to hide a random assignment list , a specific code will be assigned to each intervention group , which is only the main host of the project ( supervisor ) . these codes are written on a paper and sealed inside a sealed envelope . on this paper , as well as the envelope , a unique code for each patient will be written . also , inside each packet is a foil to make the envelope not readable under the light . each packet contains a white paper and a sheet of paper . all packets are arranged in order of random sequence within a box - box and sealed in the seal box . the main researcher , after examining the criteria of entering the study and obtaining informed consent and also registration of the patient " s specifications in special form , is called " " random assignment list " " ( this person is an expert who is involved in the process of entry and entry of the sample ) . also , before opening the envelope , the person must write the name and name of the family and the person 's age on the envelope in such a way that the manuscript falls on the paper in the envelope , Blinding description: According to the type of intervention, only the primary outcome evaluator is unaware of the type of intervention and also the data is provided to the statistical expert for statistical analysis in a blind and randomized code. N/A Parkinson's patients. Intervention 1: Intervention group: Occupational therapy exercises are performed in a clinic using simple sports equipment such as steps, large balls, as well as stationary bicycles or treadmills. The duration of the exercises is 4 weeks and 6 days a week for one hour. They do 5 days in the clinic and one day they have to do exercises at home. Intervention 2: Control group: There is no specific treatment for these people. 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 Not applicable in this study.
public Zahra Kargarian Marvasti
Ganj Afrooz St., Babol University of Medical Sciences
Babol Iran (Islamic Republic of) 47176-47745 +98 11 3219 0560 zkargarian.marvaste@gmail.com Babol University of Medical Sciences scientific Samaneh Pourhadi
Ganj Afrooz St., Babol University of Medical Sciences
babol Iran (Islamic Republic of) 4717647745 +98 11 3219 0560 samaneh.pourhadi@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) Achieving a score higher than 4 in the Freezing Walking Questionnaire,, being in stage 2 to 5 of the severity of Parkinson's disease and Yar having the minimum literacy to participate in research (part of cognitive occupational therapy exercises and following instructions) obtaining a score 21 and above In the Mini-Mental State Examination. age over 60 years 60 years no limit Both severe mental disorders. ( from the medical case of elderly people with Parkinson 's , and asking for their professional doctor ) heart disease and blood pressure vision problems the history of deep stimulation stimulation G20 Parkinson disease Rehabilitation N/A Intervention group: Occupational therapy exercises are performed in a clinic using simple sports equipment such as steps, large balls, as well as stationary bicycles or treadmills. The duration of the exercises is 4 weeks and 6 days a week for one hour. They do 5 days in the clinic and one day they have to do exercises at home. Control group: There is no specific treatment for these people. Freezing Of Gait. Timepoint: Before and after the intervention. Method of measurement: Freezing Of Gait Questionnaire (FOG). Psychological symptoms. Timepoint: Before and after the intervention. Method of measurement: Brief Symptome Inventory (BSI-18). Babol University of Medical Sciences Approved 2020-11-14 Ethics Committee of Babol University of Medical Sciences Ganj Afrooz St., Babol University of Medical Sciences Babol Mazandaran Iran (Islamic Republic of)