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
Design
A randomized, controlled, double-blind, parallel-group clinical trial on 44 patients. Randomization will be done with the method of random block permutations.
Settings and conduct
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).
Participants/Inclusion and exclusion criteria
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.
Intervention groups
The interventional group receives traditional treatments and kinesiology tape simultaneously, and the control group receives only traditional treatments.
Main outcome variables
The score of the Penetration-Aspiration Scale; The score of Oral phase impairment, Pharyngeal phase impairment, Pharyngeal phase delay, and Aspiration.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230730058973N1
Registration date:2023-10-09, 1402/07/17
Registration timing:registered_while_recruiting
Last update:2023-10-09, 1402/07/17
Update count:1
Registration date
2023-10-09, 1402/07/17
Registrant information
Name
Fatemeh Saadat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5325 3123
Email address
saadat.fa@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2024-06-21, 1403/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effectiveness of Using kinesiology Taping in the Treatment of Oropharyngeal Dysphagia in Stroke Patients Hospitalized in a Rehabilitation Unit
Public title
Effect of kinesiology Taping in treatment of Oropharyngeal Dysphagia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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, and the score of the Persian version of Mini-mental state examination should be above 22 (23 or more)
Exclusion criteria:
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
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz jundishapur University of Medical Sciences
Street address
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.
City
Tehran
Province
Tehran
Postal code
0000000000
Approval date
2023-08-12, 1402/05/21
Ethics committee reference number
IR.AJUMS.REC.1402.285
Health conditions studied
1
Description of health condition studied
Oropharyngeal Dysphagia
ICD-10 code
R13.12
ICD-10 code description
Dysphagia, oropharyngeal phase
Primary outcomes
1
Description
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
2
Description
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
3
Description
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
4
Description
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
5
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Rehabilitation
2
Description
Control group: Patients in this group will onely receive traditional treatment for oropharyngeal dysphagia. The traditional treatment techniques used in this study will be presented to the patients of both groups during 18 treatment sessions ( 9 days and 2 sessions per day) and include exercises for the range of motion of the lips (Lip Protrusion, Lip Retraction, Lip Retraction and Protrusion; each exercise 5 seconds, 8 times repetitions), jaw range of motion exercises (Jaw Opening, Side-to-Side Movement; each exercise 5 seconds, 8 repetitions), resistance exercises and tongue range of motion (Tongue Extension, Tongue Retraction, Tongue Extension and Retraction, Tongue Side To Sid, Tongue Push Up, Tongue Push Forward, Tongue Push To The Side, Tongue Inside Push; each exercise 5 seconds, 8 repetitions), shaker exercise or short-term head lift, 10 repetitions, 3 times), Mendelssohn maneuvers ( 10 repetitions, 2 times) and Effortful swallow (10 repetitions, 2 times).
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Majid Soltani
Street address
Golestan educational and specialized and subspecialty medical center, farvardin Ave, Golestan highway, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135733133
Phone
+98 61 3320 4501
Email
golestanjpspital@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
peyman zamani
Street address
research deputy, School of rehabilitation sciences, Ahvaz Jundishapur University of Medical science, Golestan highway, Ahvaz
City
ahvaz
Province
Khouzestan
Postal code
6135733133
Phone
+98 61 3374 3108
Email
Ahvaz-rehab@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Majid Soltani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Department of Speech Therapy, School of Rehabilitation Sciences, Ahvaz Jundishapur University of Medical Science, Golestan Highway, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135733133
Phone
+98 61 3374 3101
Email
soltani-m@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Majid Soltani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Department of Speech Therapy, School of Rehabilitation Sciences, Ahvaz Jundishapur University of Medical Science, Golestan Highway, Ahvaz.
City
Ahvaz
Province
Khouzestan
Postal code
6135733133
Phone
+98 61 3374 3101
Email
soltani-m@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Majid Soltani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Department of Speech Therapy, School of rehabilitation sciences, Ahvaz Jundishapur University of Medical Science, Golestan Highway, Ahvaz.
City
Ahvaz
Province
Khouzestan
Postal code
6135733133
Phone
+98 61 3374 3101
Email
soltani-m@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available