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IRCT20250609066145N1 IRCT 2025-07-15 Iran University of Medical Sciences Early intervention of dysphagia in patient with multiple sclerosis MS The effect of the early swallowing intervention for prevention of dysphagia in patient with multiple sclerosis 2025-07-11 anticipated 5 Complete https://irct.ir/trial/84285 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: In order to determine the sample size, at least 5 patients will be randomly assigned to each group, and then, based on the analysis during implementation, the overall sample size of the study will be determined, Randomization description: The research sample includes patients with MS referring to medical centers affiliated with Iran and Tehran Universities of Medical Sciences, who will be included in the study using a convenience sampling method. Patients who meet the inclusion criteria will be allocated between the two groups using random allocation in creating a random sequence and observing allocation concealment using the variable block method. Given that the sample size of the study will be determined during implementation, it is not possible to specify the exact specifications of the blocks after each block at this time, but at least 5 codes from the first method and 5 codes from the second method will be included in each block. Each block will be placed in a box containing opaque envelopes with two treatment method codes. The blocks will be used for the lottery one after the other. The envelopes will be in the possession of the secretary, who will randomly select an envelope and give it to the patient. The patient then hands the therapist a sheet containing the name of their treatment group. Considering the effect of intervening variables on the dependent variables of the study, when assigning samples to groups, attention is paid to the homogeneity of the two groups in intervening variables, Blinding description: The current study is a double-blind study in which the assessor and patients in the study are blinded. 0 (exploratory trials) Multiple sclerosis. Intervention group: There is an intervention group where patients in this group will receive swallowing therapy interventions such as swallowing maneuvers, sensory-motor interventions, and motor interventions.. Yes - There is a plan to make this available What will be shared: In this study, data from the MASA, Robs & Kley, and EDSS questionnaires can be shared as patient outcomes and before and after results after de-identification. When: The data will be available in a paper about a year from now. To whom: The data will also be accessible just for academic researchers. Conditions: For individuals, only the patient's gender and scores before and after the assessments will be available. Where to obtain: Dr.Leila Ghelichi lghelichi@gimail.com Minoo Shahbazifar mino.shahbazifar@gmail.com How to obtain: After the requester has made a request and explained his/her need for access to the documents, the information will be sent to the requester after review and if the team agrees. Comments:
public Leila Ghelichi
Faculty of Rehabilitation Sciences, Mirdamad, Shah Nazari St., Madadkaran St
Tehran Iran (Islamic Republic of) 89171683192 +98 990 967 3192 mino.shahbazifar@gmail.com Iran University of Medical Sciences scientific Leila Ghelichi
Faculty of Rehabilitation Sciences, Mirdamad, Shah Nazari St., Madadkaran St
Tehran Iran (Islamic Republic of) 89171683192 +98 990 967 3192 mino.shahbazifar@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Based on the diagnosis of a specialist, the patient has MS. The participant's MASA score should be between 180-199 (with emphasis on signs of inability to close the lips, drooling, decreased strength and range of motion of the tongue, decreased laryngeal ascent, and hoarseness). The participant does not receive a negative score on the DYMAS screening test. The age range of the participant is 18-55 years. The disease has not relapsed within a month and is not being treated with steroid medications. The patient has no history of cognitive or dysarthric speech disorders. The patient does not have psychological disorders. The patient has not undergone any treatment program to improve her swallowing disorder. There is no history of comorbidities such as stroke, Parkinson's, cervical spinal cord injury, concussion, myasthenia gravis, and amyotrophic lateral sclerosis in the patient's medical history. 18 years 55 years Both Refluxed during treatment pregnancy The patient's unwillingness to continue the treatment process Recurrence of the disease G35 Multiple sclerosis Prevention Intervention group: There is an intervention group where patients in this group will receive swallowing therapy interventions such as swallowing maneuvers, sensory-motor interventions, and motor interventions. MASA questionnaire score, Robbins-Kelly test score, patient age. Timepoint: Before intervention, after intervention, 2 months after intervention, 4 months after intervention, 6 months after intervention. Method of measurement: Dymas screening test, Disability Assessment Index, Massa questionnaire, Robbins and Kelly test. What is the MASA score in each of the evaluation phases for the therapy group?What is the average score of the Robbins-Kelly test in each of the evaluation phases, divided by treatment groups?. Timepoint: 2 months after intervention, 4 months after intervention, 6 months after intervention. Method of measurement: Dysphagia in Multiple Sclerosis screening tool to determine the presence or absence of swallowing disorder, Expanded Disability Status Scale tool to measure the patient's disability, Mann Assessment of Swallowing Ability questionnaire to determine swallowing problems in MS patients, Robbins and Kelly questionnaire to determine the motor part of the speech organs and swallowing. Iran University of Medical Sciences Approved 2025-06-13 Ethics Committee of Iran University of Medical Sciences Faculty of Rehabilitation Sciences, Iran University of Medical Sciences, Mirdamad, Shah Nazari St., Madadkaran St. Tehran Tehran Iran (Islamic Republic of)