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IRCT20210516051322N1 IRCT 2021-07-25 Research Deputy of Tarbiat Modares University Effects of rotational exercises on the stability of patients with Parkinson’s disease Effects of 10-week exercise therapy in transverse plane at home on postural stability and initiation of gait in patients with Parkinson’s disease: a clinical trial 2021-08-06 anticipated 32 Complete https://irct.ir/trial/56418 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Having entered the patients in accordance with the inclusion criteria, concealed envelopes containing an equal sample size number of exercise or control statements will be provided to an uninformed person, such as a laboratory expert. He chooses one of the envelopes and thus the patient is placed in one of the two groups of control or exercise (intervention) in a simple and individual way. The result will be hidden only from the participating patient and the researchers are aware, Blinding description: Those responsible for data collection and those assessing the outcome are kept blind to the intervention groups. This is done by assigning neutral codes to the participants (without giving information about patients' intervention grouping like S12). N/A Parkinson Disease. Intervention 1: Intervention group: Horizontal plane exercise with common exercises.5 exercises that include body rotation exercises are added to the usual exercises. Each movement is performed at the beginning of the training sessions in two sets of ten. Between each set, the patient rests for 1 minute and once every two weeks, according to the physiotherapist, the number of exercises is increased by 20%. Exercises are done for 10 weeks and 3 days every week. Intervention 2: Control group: Common exercise therapy. Each movement is performed at the beginning of the training sessions in two sets of ten. Between each set, the patient rests for 1 minute and once every two weeks, according to the physiotherapist, the number of exercises is increased by 20%. Exercises are done for 10 weeks and 3 days every week. Yes - There is a plan to make this available What will be shared: All processed and analyzed data will be released. These data include the questionnaire scores and linear and nonlinear outcomes of the stability, before and after the interventions. When: from 6 months after the official publication of results To whom: All academic and clinical researchers Conditions: Only for therapeutical applications, use in neuro-musculoskeletal simulations, and designing rehabilitation assistive devices Where to obtain: By contacting the corresponding author of the published papers by email, phone or postal address How to obtain: Process: 1. Determining the data of interest by the applicant 2. contacting the corresponding author to submit the queries by the applicant 3. Reviewing the queries by the research team 4. Responding to the queries till 10 working days by the research team Comments:
public Amir Dodangeh
Jalal AleAhmad Nasr
Tehran Iran (Islamic Republic of) 14115-111 +98 21 8288 5052 amirdodangeh76@gmail.com Tarbiat Modares University scientific Mohammed Najafi Ashtiani
Jalal AleAhmad Nasr
Tehran Iran (Islamic Republic of) 14115-111 +98 21 8288 5052 mnajafi1987@gmail.com Tarbiat Modares University Iran (Islamic Republic of) Male or female patients with Parkinson's disease diagnosed by a specialist h&y criterion score between 2 and 3 able to walk without assistance Be treated with a fixed dose of dopaminergic drugs during the evaluation and exercise therapy and re-evaluation process able to perform simple verbal commands The age of the participants is 40 to 75 40 years 75 years Both Existence of a specific musculoskeletal, cardiorespiratory, balance, visual, or cognitive disorder that exercises affect the patient's gait Having diabetes any neurological problem other than Parkinson's DBS surgery in the last 6 months Participating in regular exercise therapy programs for the past 6 months Use of walking aids body mass index of 35 or more G20 Parkinson's disease Rehabilitation Rehabilitation Intervention group: Horizontal plane exercise with common exercises.5 exercises that include body rotation exercises are added to the usual exercises. Each movement is performed at the beginning of the training sessions in two sets of ten. Between each set, the patient rests for 1 minute and once every two weeks, according to the physiotherapist, the number of exercises is increased by 20%. Exercises are done for 10 weeks and 3 days every week. Control group: Common exercise therapy. Each movement is performed at the beginning of the training sessions in two sets of ten. Between each set, the patient rests for 1 minute and once every two weeks, according to the physiotherapist, the number of exercises is increased by 20%. Exercises are done for 10 weeks and 3 days every week. Linear and nonlinear metrics of stability based on the excursion of the center of foot pressure (CoP). Timepoint: Before the intervention and immediately after the intervention(10 weeks after start). Method of measurement: Force Plate system. Parkinson's disease quality of life questionnaire PDQ39. Timepoint: Before the intervention and immediately after the intervention(10 weeks after start). Method of measurement: questionnaire score using 5-point Likert scale. Research Deputy of Tarbiat Modares University Approved 2021-06-28 Tarbiat Modares University Ethics Committee Jalal AleAhmad., Nasr Tehran Tehran Iran (Islamic Republic of)