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IRCT20200915048732N1 IRCT 2020-12-03 Shiraz University of Medical Sciences The evaluation of the additive value of cognitive task on whole body vibration on balance and cognition in multiple sclerosis The evaluation of the additive value of performing cognitive task while inducing whole body vibration on balance indices and cognition in multiple sclerosis patients 2021-01-20 anticipated 40 Complete https://irct.ir/trial/50974 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be assigned to each group by applying Random Allocation software, in a blocking method (size of 4). Group allocation will be defined in a block of four (2 participants in each group) and continue to put all 40 participants into two groups of Intervention and control, Blinding description: Data analyser and the physiotherapist who will measure the outcome measures, will be blinded to the patient’s allocation group. N/A Multiple sclerosis. Intervention 1: Intervention group: Patients are treated for 6 weeks, 3 sessions per week, 5 set per session by whole body vibration apparatus at the same time as performing Stroop cognitive task. In this task, congruent and incongruent colored words will be shown to the patients randomly in each trial. In the congruent condition the word and its color are the same and in the incongruent condition the word and its color will be different. For example, the word "blue" will be displayed in a different color; for example, with yellow color letters. Vibration rate in the first 2 weeks 5 set of 30 seconds with 1 minute break between sets, in the second 2 weeks 5 set of 45 seconds with 1 minute break between sets and in the third 2 weeks 5 set of 1 minute with 1 minute break is between sets. Intervention 2: Control group: This group is treated by only whole body vibration apparatus. Vibration rate is as the same as intervention group. 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 Mahsa Badpa
Rehabilitation School of Shiraz University of Medical Sciences, Abiverdi 1 St., Chamran Blvd.
Shiraz Iran (Islamic Republic of) 33669-71947 +98 71 3627 1551 m_badpa@sums.ac.ir Shiraz University of Medical Sciences scientific Dr. Mohsen Razeghi
Rehabilitation School of Shiraz University of Medical Sciences, Abiverdi 1 St., Chamran Blvd.
Shiraz Iran (Islamic Republic of) 33669-71947 +98 71 3627 1551 razeghm@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Age range of 20-50 years A definite diagnosis of MS, Relapsing-remitting type, as diagnosed by a neurologist Patients with mild to moderate disability (EDSS = 1-5.5) who are able to stand or ambulate independently. (ambulate at least 100 meters independently without aids or assistance) Literacy Fluent and understandable speech 20 years 50 years Both Pregnancy A positive history of having fracture and implant in the knee and hip joints History of epilepsy Malignant tumors Corticosteroid injection 28 days before the intervention Severe osteoporosis Discopathy, Acute protrusion, Spondylolisthesis Severe diabetes Severe wounds and scarring Any musculoskeletal or neurological conditions except MS limiting balance Uncorrected auditory or visual impairment Disorders of the vestibular system at the diagnosis of a specialist Severe mental disorders that lead to impossibility of cooperation of the participant. Using drugs which affecting balance Vertigo History of attacks and relapses during the past 2 months Having experience of vibration during the last 3 months Receive physiotherapy interventions simultaneously or up to 1 month before the start of the research project G35 Multiple sclerosis Rehabilitation Rehabilitation Intervention group: Patients are treated for 6 weeks, 3 sessions per week, 5 set per session by whole body vibration apparatus at the same time as performing Stroop cognitive task. In this task, congruent and incongruent colored words will be shown to the patients randomly in each trial. In the congruent condition the word and its color are the same and in the incongruent condition the word and its color will be different. For example, the word "blue" will be displayed in a different color; for example, with yellow color letters. Vibration rate in the first 2 weeks 5 set of 30 seconds with 1 minute break between sets, in the second 2 weeks 5 set of 45 seconds with 1 minute break between sets and in the third 2 weeks 5 set of 1 minute with 1 minute break is between sets. Control group: This group is treated by only whole body vibration apparatus. Vibration rate is as the same as intervention group. Static balance. Timepoint: Before and after intervention. Method of measurement: Biodex balance system. Dynamic balance. Timepoint: Before and after intervention. Method of measurement: Biodex balance system. Functional balance. Timepoint: Before and after intervention. Method of measurement: Mini Balance Evaluation Systems Test (Mini- BESTest). Balance confidence. Timepoint: Before and after intervention. Method of measurement: Activities Specific Balance Confidence scale (ABC). Risk of falling. Timepoint: Before and after intervention. Method of measurement: Biodex balance system. Cognitive performance. Timepoint: Before and after intervention. Method of measurement: Montreal Cognitive Assessment Test (MOCA), Symbol Digit Modalities Test (SDMT). Quality of life. Timepoint: Before and after intervention. Method of measurement: Multiple Sclerosis Quality of Life-54 Questionnaire (MSQoL-54). Shiraz University of Medical Sciences Approved 2020-05-20 Ethics committee of Shiraz University of Medical Sciences Rehabilitation School of Shiraz University of Medical Sciences, Abiverdi 1 St., Chamran Blvd. Shiraz Fars Iran (Islamic Republic of)