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IRCT20180804040685N5 IRCT 2023-04-23 Tehran University of Medical Sciences Effects of telerehabilitation in multiple sclerosis Effects of supervised exercise program via telerehabilitation on gait and quality of life in patients with multiple sclerosis 2023-04-15 anticipated 38 Complete https://irct.ir/trial/69528 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The participants are randomly allocated to two parallel groups using the block randomization technique. The block size is six and randomize the allocation of intervention or control within each block can be done by using a random number generator. Once the randomization within each block is completed, assign the participants to their respective intervention or control group based on randomization results to make balance within each block. Then, continue the process for subsequent blocks until all of them are assigned. The blinding and concealment of the randomization process also will be done, Blinding description: Those who evaluate the outcome and those responsible for data collection do not know about the allocation of groups and the information of individuals is given in terms of numbers. N/A Multiple sclerosis rehabilitation, telerehabilitation, walking disabilities, quality of life. Intervention group: The intervention group underwent remote rehabilitation during 12 sessions of 1 month and a half through a designed exercise protocol (including stretching, aerobic, strength exercises) and under the supervision of a physical medicine and rehabilitation doctor via video calls. and all the necessary evaluations and tests before and after the sports intervention are done offline and with the cooperation of the telepartner.. 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 further information
public Hamid Reza Fateh
Shariati Hospital, Jalal Al Ahmad Street, Kargar Street, Tehran
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 2110 hr-fateh@tums.ac.ir Tehran University of Medical Sciences scientific Hamid Reza fateh
Tehran, North Kargar St, Jalal Al Ahmad Street, Shariati Hospital, Physical medicine and rehabilitation department
Tehran Iran (Islamic Republic of) 14117 13135 +98 21 8490 2110 hr-fateh@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Diagnosis of multiple sclerosis based on Mc Donalds criteria Expanded Disability Status Scale <6 No recurrence of the disease in the last 30 days 18 years 55 years Both Patients with severe disease who are unable to walk Active phase of the disease Associated underlying disease Pregnant women G35 Multiple sclerosis Rehabilitation Intervention group: The intervention group underwent remote rehabilitation during 12 sessions of 1 month and a half through a designed exercise protocol (including stretching, aerobic, strength exercises) and under the supervision of a physical medicine and rehabilitation doctor via video calls. and all the necessary evaluations and tests before and after the sports intervention are done offline and with the cooperation of the telepartner. Timed up and go test (TUG), 2-minute walk test (2MWT), multiple sclerosis impact scale-29 (MSIS-29). Timepoint: Before and immediately after the end of the intervention and after 2 months. Method of measurement: TUG is the time measured with the stopwatch from the time the patient gets up from the chair and walks 3 meters and returns and sits on the chair, and 2MWT is measured with the meter. The distance with maximum amount of walking power in 2 minutes, and the quality of life is measured by MSIS-29 questionnaire. Berg balance scale, muscle force, fatigue severity scale. Timepoint: Before and immediately after the end of the intervention and after 2 months. Method of measurement: Fatigue severity is measured by a questionnaire, static and dynamic balance is measured by a Berg balance questionnaire, and muscle strength is measured by a manual muscle strength test. Tehran University of medical Sciences Approved 2023-04-09 Ethics Committee of Tehran University of Medical Sciences Karger St., Jalal Al Ahmad Street, Shariati hospital Tehran Tehran Iran (Islamic Republic of)