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IRCT20230730058973N1 IRCT 2023-10-09 Ahvaz University of Medical Sciences Effect of kinesiology Taping in treatment of Oropharyngeal Dysphagia Evaluation of the Effectiveness of Using kinesiology Taping in the Treatment of Oropharyngeal Dysphagia in Stroke Patients Hospitalized in a Rehabilitation Unit 2023-09-23 anticipated 20 Complete https://irct.ir/trial/71824 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients included in the study will be placed in two experimental and control groups completely randomly and by random block permutations. The www.sealedenvelope.com website will be used to create random blocks for assigning people to groups. First, a sequence of four blocks will be made. Considering that we have two groups in this study, our blocks of four can be as follows: AABB, ABAB, BABA, BBAA, BAAB, ABBA In these blocks, the letters A and B represent our groups. Then, these six blocks will be numbered and samples will be taken from these six blocks in the form of placement. These blocks will then be put together to form our randomization sequence, Blinding description: This study is designed in a manner where the participants, outcome assessors, and data analysts will not know which group each participant is assigned to. As a result, this study is considered to be double-blinded. The participants will be informed of the treatment they will receive, but will not be aware of the treatment given to the other group. They also will not know whether they are in the experimental or control group. Outcome assessors will be unaware of which group, the patient they are assessing belongs to. Also, the data given to the analysts will be named with codes and numbers so that the analysts will not know which data belongs to which group. N/A Oropharyngeal Dysphagia. Intervention 1: Intervention group: This group will receive traditional treatment techniques and kinesiology tape (Sportex, Korea) simultaneously. The treatment will be presented to the patients during 18 treatment sessions ( 9 days and 2 sessions per day). For treatment with kinesiology tape, after cleaning the skin of the anterior neck area completely, an I-shaped tip will first be pulled down from the notch of the thyroid cartilage and attached to the sternum. Then, another V-shaped strip will be connected from the trunk of the hyoid bone to the upper surface of the inner part of the clavicle with downward tension. Then, a transverse tip is placed on the entire hyolaryngeal complex for further restriction. The approximate tension of the types used will be 70%. Traditional therapeutic exercises will be performed on the patients after taping, and the tapes will be attached every day before the start of the first daily session and removed after the end of the second treatment session. Intervention 2: Control group: Patients in this group will only receive traditional treatment for oropharyngeal dysphagia. The traditional treatment used in this study will be determined by a specialist speech-language pathologist based on the results of each patient's clinical assessment. A specific treatment plan will be designed for each patient, including oral sensory stimulation, oral motor exercises (strength, resistance, and range of motion exercises for the lips, jaw, and tongue), swallowing maneuvers (shaker exercise, Mendelssohn maneuvers, labored swallowing, etc.), and compensatory strategies (postural changes, awareness of food consistency, viscosity, and temperature). 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 Majid Soltani
Department of Speech Therapy, School of Rehabilitation Sciences, Ahvaz Jundishapur University of Medical Science, Golestan Highway, Ahvaz
Ahvaz Iran (Islamic Republic of) 6135733133 +98 61 3374 3101 soltani-m@ajums.ac.ir Ahvaz University of Medical Sciences scientific Majid Soltani
Department of Speech Therapy, School of Rehabilitation Sciences, Ahvaz Jundishapur University of Medical Science, Golestan Highway, Ahvaz.
Ahvaz Iran (Islamic Republic of) 6135733133 +98 61 3374 3101 soltani-m@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) The occurrence of stroke in these patients should have been confirmed by a neurologist More than 2 weeks should have passed since their stroke onset An experienced speech and language pathologist should have confirmed the presence of oral-pharyngeal dysphagia in these patients by flexible endoscopic evaluating of swallowing Dysphagia sgould be caused due to a stroke and should not be caused by surgery or drug toxicity Patients should be able to perform voluntary swallowing in these patients and should not be fed through nasogastric tubes Patients should have the essential level of alertness and cognitive ability to follow orders and implement treatment techniques. 18 years 70 years Both Impairment in the Esophageal phase of swallowing History of neurological diseases History of neuromuscular diseases in the head and neck region of the patients Tracheostomy Any specific skin disease or wound in the anterior neck region R13.12 Dysphagia, oropharyngeal phase Rehabilitation Rehabilitation Intervention group: This group will receive traditional treatment techniques and kinesiology tape (Sportex, Korea) simultaneously. The treatment will be presented to the patients during 18 treatment sessions ( 9 days and 2 sessions per day). For treatment with kinesiology tape, after cleaning the skin of the anterior neck area completely, an I-shaped tip will first be pulled down from the notch of the thyroid cartilage and attached to the sternum. Then, another V-shaped strip will be connected from the trunk of the hyoid bone to the upper surface of the inner part of the clavicle with downward tension. Then, a transverse tip is placed on the entire hyolaryngeal complex for further restriction. The approximate tension of the types used will be 70%. Traditional therapeutic exercises will be performed on the patients after taping, and the tapes will be attached every day before the start of the first daily session and removed after the end of the second treatment session. Control group: Patients in this group will only receive traditional treatment for oropharyngeal dysphagia. The traditional treatment used in this study will be determined by a specialist speech-language pathologist based on the results of each patient's clinical assessment. A specific treatment plan will be designed for each patient, including oral sensory stimulation, oral motor exercises (strength, resistance, and range of motion exercises for the lips, jaw, and tongue), swallowing maneuvers (shaker exercise, Mendelssohn maneuvers, labored swallowing, etc.), and compensatory strategies (postural changes, awareness of food consistency, viscosity, and temperature). The score of Penetration-Aspiration Scale. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the 18th treatment session. Method of measurement: Flexible Endoscopic Evaluation of Swallowing. The score of Oral phase impairment. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the 18th treatment session. Method of measurement: Northwestern Dysphagia Patient Check Sheet. The score of Pharyngeal phase impairment. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the 18th treatment session. Method of measurement: Northwestern Dysphagia Patient Check Sheet. The score of Pharyngeal phase delay. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the 18th treatment session. Method of measurement: Northwestern Dysphagia Patient Check Sheet. The score of Aspiration. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the 18th treatment session. Method of measurement: Northwestern Dysphagia Patient Check Sheet. Ahvaz University of Medical Sciences Approved 2023-08-12 Ethics Committee of Ahvaz Jundishapur University of Medical Sciences 13th Floor, Block A, Central Headquarters of the Ministry of Health, Treatment and Medical Education, Between South Flamak and Zarafshan, Simai Iran St., Qods (west), Twon. Tehran Tehran Iran (Islamic Republic of)