Evaluation of the Effectiveness of Using kinesiology Taping in the Treatment of Oropharyngeal Dysphagia in Stroke Patients Hospitalized in a Rehabilitation Unit

Determining the effectiveness of Kinesio tape in the treatment of oropharyngeal dysphagia in stroke patients

A randomized, controlled, double-blind, parallel-group clinical trial on 44 patients. Randomization will be done with the method of random block permutations.

44 patients who are selected among the patients hospitalized in the stroke rehabilitation department of Golestan Ahvaz Hospital by the available sampling method, will be placed in two experimental and control groups completely randomly and by random block permutations. The patients of both groups will be treated for 9 days, twice a day. Before and after the treatment they will be evaluated through the Farsi version of the Northwestern Dysphagia Checklist and Flexible Endoscopic Evaluation of Swallowing (penetration-aspiration scale).

Inclusion criteria: the occurrence of stroke, the presence of oropharyngeal dysphagia, the ability to perform voluntary swallowing, the Essential level of alertness and cognitive ability, and the score of the Persian version of the Mini-mental state examination above 22. Exclusion criteria l: Impairment in the Esophageal phase of swallowing, history of neurological diseases, history of neuromuscular diseases in the head and neck region, tracheostomy, and any specific skin disease or wound in the anterior neck area.

The interventional group receives traditional treatments and kinesiology tape simultaneously, and the control group receives only traditional treatments.

The score of the Penetration-Aspiration Scale; The score of Oral phase impairment, Pharyngeal phase impairment, Pharyngeal phase delay, and Aspiration.

Given that this research was conducted as part of a student thesis, its implementation was subject to time constraints. Additionally, the study was carried out in a ward with limited capacity (five beds) and stringent inclusion criteria, which further complicated the recruitment process. The criteria for patient inclusion in the study were numerous and restrictive, making it challenging to achieve the initial sample size within the available timeframe. Consequently, the research team, in consultation with a statistical consultant, decided to proceed with a smaller sample size and to conduct the study as a pilot trial. Also, in the methods section, the research team concluded that traditional treatment methods should be tailored specifically to each patient, based on existing studies, to enhance treatment effectiveness. The primary outcome measures were renamed to enhance clarity and ensure they more accurately reflected the variables being assessed. The MMSE score was removed from the inclusion criteria to facilitate the inclusion process. Finally, since the sampling has concluded, the start and end dates of the sampling need to be updated.

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.

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