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IRCT20200919048753N1 IRCT 2020-11-20 Shiraz University of Medical Sciences effectiveness of added cognitive task training to multi directional treadmill training in patients with Parkinson's disease Investigating the added value of cognitive task training on a multi directional treadmill training program on gait parameters in patients with Parkinson’s disease: An Assessor Blind Randomized Controlled Clinical Trial 2020-12-21 anticipated 32 Complete https://irct.ir/trial/51272 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: All participants are entered to study by neurologists. According to related past studies the sample size estimated 28 subjects (14 subjects per groups) and with considering the 20% attrition with ratio of 1:1 (treadmill group:treadmill+cognitive exercise group) for each of group at least 16 subjects were considered. Assignment of people to groups will be based on the Block Balanced Randomization (BBR) method. After two months from the end of the study, follow up will be performed in both study groups, Randomization description: Assignment of patients in two groups of treadmill and treadmill + cognitive exercise was done by Block Balanced Randomization (BBR) method. The Randomization Sequence is generated with using the free web site at http://www.randomization.com. Non-transparent and sealed envelopes will be used to conceal the assignment of individuals to groups, Blinding description: The assessor will not be aware of which intervention will be administered to which subject. The data analyzer also does not know the groups (treadmill or treadmill+cognitive exercise). 2 Parkinson's disease. Intervention 1: control group : The people in the control group will be treated with treadmill exercise for 6 weeks. they will walk on treadmill in all four directions. Exercises in the control group will be offered 3 times a week, each training session lasts about 30 minutes(5min warm-up,[7min forward,7min backward,3min right sideway,3min left sideway],5min cooldown).All training sessions will be performed under the supervision of a physiotherapist. Intervention 2: Intervention group : The people in the intervention group will be treated with treadmill exercise+cognitive exercises for 6 weeks. They will walk on treadmill in all four directions. Exercises in the intervention group will be offered 3 times a week, each training session lasts about 30 minutes(5min warm-up,20min exercising[7min forward,7min backward,3min right sideway,3min left sideway],5min cooldown). Cognitive exercising will be counting backwards from 100 by subtracting 3’s, Naming words starting with a special letter such as M. All training sessions will be performed under the supervision of a physiotherapist. 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 more information.
public Fatemeh Fallahzadeh
Chamran Blvd . abiverdi1 school of rehabilitation sciences
shiraz Iran (Islamic Republic of) 7194733669 +98 71 3626 1081 ffallahzadeh@sums.ac.ir Shiraz University of Medical Sciences scientific Mohsen Razeghi
Chamran Blvd Abiverdi 1 school of rehabilitation sciences
shiraz Iran (Islamic Republic of) 7194733669 +98 71 3626 1081 razeghm@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) patients with idiopathic Parkinson's disease according to United Kingdom(UK)Bank patients in Hoehn and Yahr scale (H&Y I-III) stages of Parkinson's disease patients should be MED on state patients should be able to independent walking at least for 6 min based on Unified Parkinson's Disease Rating Scale (UPDRS) Montreal Cognitive Assessment (MOCA)≤24 for cognitive system no limit no limit Both other neurological disorders such as CVA, Alzheimer, severe neuropathic impairments A history of any serious orthopedic problems such as surgery or fractures that prevent you from walking on the treadmill Existence of any severe respiratory and pulmonary diseases that prevent the intervention protocol Having a history of heart failure or coronary heart disease and stroke that prevents the intervention protocol Existence of hearing and vision impairment that prevents the correct performance of tests History of head and neck surgery History of Deep Brain Stimulation History of malignant diseases that prevent the intervention protocol Musculoskeletal pain that prevents the intervention protocol Participate in exercise programs such as treadmills for at least the past two months G20 Parkinson's disease Treatment - Other Treatment - Other control group : The people in the control group will be treated with treadmill exercise for 6 weeks. they will walk on treadmill in all four directions. Exercises in the control group will be offered 3 times a week, each training session lasts about 30 minutes(5min warm-up,[7min forward,7min backward,3min right sideway,3min left sideway],5min cooldown).All training sessions will be performed under the supervision of a physiotherapist. Intervention group : The people in the intervention group will be treated with treadmill exercise+cognitive exercises for 6 weeks. They will walk on treadmill in all four directions. Exercises in the intervention group will be offered 3 times a week, each training session lasts about 30 minutes(5min warm-up,20min exercising[7min forward,7min backward,3min right sideway,3min left sideway],5min cooldown). Cognitive exercising will be counting backwards from 100 by subtracting 3’s, Naming words starting with a special letter such as M. All training sessions will be performed under the supervision of a physiotherapist. Walking speed. Timepoint: before intervention, immediately after 6 weeks of intervention, after 2 moths from the end of intervention. Method of measurement: 6 min walking test. Stride length. Timepoint: before intervention, immediately after 6 weeks of intervention, after 2 moths from the end of intervention. Method of measurement: meters. Motor system function. Timepoint: before intervention, immediately after 6 weeks of intervention, after 2 moths from the end of intervention. Method of measurement: Unified Parkinson's Disease rating Scale(UPDRS III). Cognitive function. Timepoint: before intervention, immediately after 6 weeks of intervention, after 2 moths from the end of intervention•. Method of measurement: MOCA test. The percentage difference between stride length and walking speed. Timepoint: before intervention, immediately after 6 weeks of intervention, after 2 moths from the end of intervention•. Method of measurement: Dual task cost methods(DTcost). Quality of life. Timepoint: before intervention, immediately after 6 weeks of intervention, after 2 moths from the end of intervention•. Method of measurement: PDQ39 questionnaire. Shiraz University of Medical Sciences Approved 2020-08-19 Ethics committee of research in Shiraz University of Medical Science Central building of Shiraz University of Medical Science, Zand Ave shiraz Fars Iran (Islamic Republic of)