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IRCT20201129049534N7 IRCT 2023-04-15 Esfahan University of Medical Sciences effect of texture-modified diet in stroke patients with dysphagia Investigation on the effect of texture-modified diet on dietary intake and nutritional status in stroke patients with dysphagia receiving neuromuscular electrical stimulation and traditional dysphagia therapy 2023-04-04 anticipated 80 Complete https://irct.ir/trial/68941 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: After sampling in an easy or accessible way, random allocation of samples is done using the blocking method (4 blocks based on age and sex) and individually. This is done using a reputable random number making website: https://www.sealedenvelope.com/simple-randomiser/v1/lists First, we identify one letter for each group, for example, group A (intervention group 1), group B (intervention group 2), group C (intervention group 3) and group D (intervention group 4), and thus four groups named A and B and C and D will be formed and each research unit will be given a number according to the sample size of one list of 80 people will be obtained, which will be placed in each group of 20 people. Using the website and considering the four blocks, a list consisting of the letters A and B and C and D will be prepared randomly. Each participant will be assigned to one of the groups. 3 dysphagia. Intervention 1: Intervention group 1: Will receive a texture-modified diet that includes changing the concentration of liquids and softening solid foods to make them easier to swallow, along with electrotherapy including neuromuscular electrical stimulation with a frequency of 10 Hz for 20 minutes per session to strengthen the muscles of the laryngeal area as well as traditional swallowing therapy. Intervention 2: Intervention group 2: will receive electrotherapy including neuromuscular electrical stimulation with a frequency of 10 Hz for 20 minutes per session to strengthen the muscles of the laryngeal area and traditional swallowing therapy. Intervention 3: Intervention group 3: will receive a texture-modified diet that includes changing the concentration of liquids and softening solid foods to make them easier to swallow, along with traditional swallowing therapy. Intervention 4: Intervention group 4: will receive only traditional swallowing therapy. No - There is not a plan to make this available Justification or reason for not sharing IPD is Because of privacy of findings of study
public Mohammad baghernia
Hezar-jerib Ave, Isfahan University of Medical Sciences,Isfahan University of Medical Sciences, Isfahan,Iran
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3668 7898 bagherniya@nutr.mui.ac.ir Esfahan University of Medical Sciences scientific Mohammad baghernia
Hezar-jerib Ave, Isfahan University of Medical Sciences, Isfahan University of Medical Sciences,Isfahan,Iran
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3668 7898 bagherniya@nutr.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) chronic stroke patients with swallowing disorder the age between 50-70 years presence of dysphagia 50 years 70 years Both presence of dysphagia before stroke feeding with tube sever liver disease I63 Cerebral infarction Rehabilitation Rehabilitation Rehabilitation Rehabilitation Intervention group 1: Will receive a texture-modified diet that includes changing the concentration of liquids and softening solid foods to make them easier to swallow, along with electrotherapy including neuromuscular electrical stimulation with a frequency of 10 Hz for 20 minutes per session to strengthen the muscles of the laryngeal area as well as traditional swallowing therapy. Intervention group 2: will receive electrotherapy including neuromuscular electrical stimulation with a frequency of 10 Hz for 20 minutes per session to strengthen the muscles of the laryngeal area and traditional swallowing therapy. Intervention group 3: will receive a texture-modified diet that includes changing the concentration of liquids and softening solid foods to make them easier to swallow, along with traditional swallowing therapy. Intervention group 4: will receive only traditional swallowing therapy. Nutritional status. Timepoint: before treatment, end of first,second,third and fourth weeks and one month after intervention. Method of measurement: Minimal nutritional assessment. Dietary intake. Timepoint: before treatment, end of first,second,third and fourth weeks and one month after intervention. Method of measurement: Nutritionist 4 software. Swallowing capability. Timepoint: before treatment, end of first,second,third and fourth weeks and one month after intervention. Method of measurement: Dysphagia Outcome and Severity Scale. Esfahan University of Medical Sciences Approved 2023-02-27 Ethics committee of Isfahan University of Medical Sciences Hezar Jerib street Isfahan Isfehan Iran (Islamic Republic of)