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IRCT20190618043938N1 IRCT 2021-02-11 Shiraz University of Medical Sciences Effect of combined thermal and neuromuscular stimulations on dysphagia The effect of combined thermal and neuromuscular stimulations on stroke related dysphagic patients 2021-02-18 anticipated 12 Complete https://irct.ir/trial/40291 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The subjects of this study were found by using simple random sampling. Randomization sequence was created using “random allocation” software (version 2.0) and stratified in the center, with one to one allocation using random block size of 2 by a nonclinical involvement. The blinded statistician used this software to create a “random number table”; in this table, the order of the blocks is determined. According to that, participants were randomly categorized into two groups: intervention group and control group, Blinding description: A nurse enrolled participants and assigned them to groups; interviewed the patients’ family in order to obtain written informed consent, if the eligibility criteria were met. After assignment to interventions, an examiner who was unaware of the assignments measured the outcomes, the investigator who was unaware of the assignments implemented the protocol and the results were analyzed by another investigator, who was again unaware of the assignments and interventions. N/A Condition 1: Stroke. Condition 2: Dysphagia. Intervention 1: Intervention group: This treatment protocol consists of 10 different stimulations in different areas and are performed without the use of medical gloves. These stimulations are prioritized as they are mentioned in the following: 1. Thermal stimulation of face area: This stimulation is done by using a bag of hot water which is placed on half of the face for 15 seconds. This procedure is similarly performed on the other side and repeated for 5 cycles. 2. Superficial stroking to the face: The therapist’s palm is placed on the half of face and moved down from the hairline (reaching mandible bone) for 1 minute. This procedure is similarly performed on the other side and repeated for 3 cycles. 3. Thermal stimulation of the neck area: This stimulation is done using a bag of hot water which is placed on half of the neck. The bag covered the area from the mandible bone to the clavicle bone for 15 seconds. This procedure was similarly performed on the other side of the neck and repeated for 5 cycles. During 15 seconds of stimulation, we made sure that the water temperature does not lead to rubefaction. 4. Superficial stroking to the neck: The therapist’s palm is placed on half of the neck and moved from mandible bone to clavicle bone for 1 minute. This procedure is similarly performed on the other side of the neck and repeated for 3 cycles.5. Tapping on the suprahyoid triangle of the neck: The neck is tapped gently with 4 fingertips for 1 minute. There is a 30-second break between each set, and the procedure is repeated for 3 cycles. 6. Deep stroking in anterior belly of digastric muscle: The index finger pad is kept in contact at the origin of anterior belly of digastric muscle and is moved along with the muscle fiber (reaching sternocleidomastoid muscle) in each side of the neck for 30 seconds. The same procedure is performed on the other side of the neck and repeated for 3 cycles.7. Superficial stroking to the lips: The therapist’s index finger pad is placed at the corner of the upper lip perpendicularly and moved from left to right for 30 seconds. The same procedure is performed for the lower lip and repeated for 3 cycles. 8. Tapping on lips area: The therapist’s index finger pad is placed at the corner of the upper lip perpendicularly and is tapped from left to right for 30 seconds. The same procedure is performed for the lower lip and repeated for 3 cycles. 9. Intraoral superficial stroking stimulation: For this procedure, we use a tongue blade to stimulate 6 intraoral surfaces for about 1 minute without touching the surrounding structures: tongue (from back to front before triggering the gag reflex), palate (from back to front considering palatine reflex threshold), cheeks (from the inside out), and vestibule of lips (from left to right) for upper and lower lips.10. FN (facial nerves) stimulation: This treatment consisted of 2 stages: a. FN1: The therapist stroke 5 pathways on the face (above the eyebrows, under the eyes, cheeks, around the lips that include upper lip and lower lip) with a piece of ice for 30 seconds in every direction. The similar procedure is performed on the other side of the face. b. FN2: Deep stroking to the face: The therapist’s index finger pad is placed at the start point of every 5 pathways (above the eyebrows, under the eyes, cheeks, around the lips that include upper lip and lower lip) and moved to the endpoint of both sides of the face simultaneously for 30 seconds. The same procedure is performed on the other pathways.If patients' gag reflex is completely eliminated 3 below stimulations added after above protocol: 1. Stimulate the posterior pharyngeal wall: For this procedure, we used a tongue blade to stimulate gently the posterior pharyngeal wall without touching the surrounding structures. The duration of this stimulate was until the gag reflex response observed.2. Depress root of tongue: For this stimulation, we used a tongue blade to depress gently the root of tongue without touching the surrounding structures. The duration of this stimulate was until the gag reflex response observed.3. Elevate the soft plate: For this procedure, we used a tongue blade to elevate gently the soft plate without touching the surrounding structures, for 30 seconds. Intervention 2: Control group: This group didn't receive any treatment for swallowing disorders. These people followed the instructions and medications prescribed by the doctor according to the hospital routines. Yes - There is a plan to make this available What will be shared: All data except personal information is provided. When: The start of the access period is 6 months after the acceptance of the article. To whom: In addition to the lead researcher and project supervisor, access to information may be reviewed by the Ethics Committee upon request. Conditions: Researchers can use the data of these studies if necessary and perform advanced analysis or meta-analysis studies. Where to obtain: Dr. Shiva Ebrahimian. Shiraz. Chamran Boulevard. Abivardi St. 1. Faculty of Rehabilitation Sciences. Cel No. : 09133035770 . Email: ebrahimsh@sums.ac.ir How to obtain: After 6 months of accepting the article, while announcing a written request to the executor of the project to receive information and a clear reason on how to use the information in an official letter to obtain permission from the ethics committee, comment and if approved by the ethics committee with emphasis on confidentiality The requested information is provided to the applicant. Comments:
public Atefe Hoseinzade
Rehabilitation School of Shiraz University of Medical Science. No 1. Abiverdit St. Chamran Blvd
Shiraz Iran (Islamic Republic of) 7194733669 +98 71 3626 1081 atefe.hoseinzade97@yahoo.com Shiraz University of Medical Sciences scientific Shiva Ebrahimian Dehaghani
Rehabilitation School of Shiraz University of Medical Science. No 1. Abiverdit St. Chamran Blvd
Shiraz Iran (Islamic Republic of) 7194733669 +98 71 3626 1081 ebrahimsh@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients were included in the sample if they were in the acute phase of the stroke (the first 30 days after the stroke) Patients were over 18 years of age and younger than 90 years Patients suffered from stroke-related dysphagia (in the oral and pharyngeal phases) Patients had to have a normal level of consciousness 18 years 90 years Both The patients were unwilling to participate in this study (non-cooperation or non-attendance) The patients could not collaborate in the swallowing examination because of low consciousness and low comprehension The recurrence of stroke Incidence of other neurological disorders that affect dysphagia 8B20 MD93 Fulfills criteria for stroke in that acute symptoms of focal brain injury that have lasted 24 hours or more (or led to death before 24 hours), but subtype of stroke (ischemic or haemorrhagic) has not been determined by neuroimaging or other techniques. Difficulty in swallowing which may result from neuromuscular disorder or mechanical obstruction. Dysphagia is classified into two distinct types: oropharyngeal dysphagia due to malfunction of the pharynx and upper oesophageal sphincter; and oesophageal dy Rehabilitation Rehabilitation Intervention group: This treatment protocol consists of 10 different stimulations in different areas and are performed without the use of medical gloves. These stimulations are prioritized as they are mentioned in the following: 1. Thermal stimulation of face area: This stimulation is done by using a bag of hot water which is placed on half of the face for 15 seconds. This procedure is similarly performed on the other side and repeated for 5 cycles. 2. Superficial stroking to the face: The therapist’s palm is placed on the half of face and moved down from the hairline (reaching mandible bone) for 1 minute. This procedure is similarly performed on the other side and repeated for 3 cycles. 3. Thermal stimulation of the neck area: This stimulation is done using a bag of hot water which is placed on half of the neck. The bag covered the area from the mandible bone to the clavicle bone for 15 seconds. This procedure was similarly performed on the other side of the neck and repeated for 5 cycles. During 15 seconds of stimulation, we made sure that the water temperature does not lead to rubefaction. 4. Superficial stroking to the neck: The therapist’s palm is placed on half of the neck and moved from mandible bone to clavicle bone for 1 minute. This procedure is similarly performed on the other side of the neck and repeated for 3 cycles.5. Tapping on the suprahyoid triangle of the neck: The neck is tapped gently with 4 fingertips for 1 minute. There is a 30-second break between each set, and the procedure is repeated for 3 cycles. 6. Deep stroking in anterior belly of digastric muscle: The index finger pad is kept in contact at the origin of anterior belly of digastric muscle and is moved along with the muscle fiber (reaching sternocleidomastoid muscle) in each side of the neck for 30 seconds. The same procedure is performed on the other side of the neck and repeated for 3 cycles.7. Superficial stroking to the lips: The therapist’s index finger pad is placed at the corner of the upper lip perpendicularly and moved from left to right for 30 seconds. The same procedure is performed for the lower lip and repeated for 3 cycles. 8. Tapping on lips area: The therapist’s index finger pad is placed at the corner of the upper lip perpendicularly and is tapped from left to right for 30 seconds. The same procedure is performed for the lower lip and repeated for 3 cycles. 9. Intraoral superficial stroking stimulation: For this procedure, we use a tongue blade to stimulate 6 intraoral surfaces for about 1 minute without touching the surrounding structures: tongue (from back to front before triggering the gag reflex), palate (from back to front considering palatine reflex threshold), cheeks (from the inside out), and vestibule of lips (from left to right) for upper and lower lips.10. FN (facial nerves) stimulation: This treatment consisted of 2 stages: a. FN1: The therapist stroke 5 pathways on the face (above the eyebrows, under the eyes, cheeks, around the lips that include upper lip and lower lip) with a piece of ice for 30 seconds in every direction. The similar procedure is performed on the other side of the face. b. FN2: Deep stroking to the face: The therapist’s index finger pad is placed at the start point of every 5 pathways (above the eyebrows, under the eyes, cheeks, around the lips that include upper lip and lower lip) and moved to the endpoint of both sides of the face simultaneously for 30 seconds. The same procedure is performed on the other pathways.If patients' gag reflex is completely eliminated 3 below stimulations added after above protocol: 1. Stimulate the posterior pharyngeal wall: For this procedure, we used a tongue blade to stimulate gently the posterior pharyngeal wall without touching the surrounding structures. The duration of this stimulate was until the gag reflex response observed.2. Depress root of tongue: For this stimulation, we used a tongue blade to depress gently the root of tongue without touching the surrounding structures. The duration of this stimulate was until the gag reflex response observed.3. Elevate the soft plate: For this procedure, we used a tongue blade to elevate gently the soft plate without touching the surrounding structures, for 30 seconds. Control group: This group didn't receive any treatment for swallowing disorders. These people followed the instructions and medications prescribed by the doctor according to the hospital routines. Swallowing Disorder. Timepoint: Swallowing disorder is measured by Mann assessment swallowing ability (MASA) test at the beginning of the study (before the start of the study) and 7, 14, 21, 28 and 35 days after the intervention. Method of measurement: Mann assessment swallowing ability (MASA) test. Oral Movements. Timepoint: Oral movements are measured by the Motility function test at the beginning of the study (before the start of the study) and 7, 14, 21, 28 and 35 days after the intervention. Method of measurement: Motility function test. Shiraz University of Medical Sciences Approved 2019-03-11 Ethics Committee of Shiraz University of Medical Sciences rehabilitation school of shiraz university of medical science. No.1 Abiverdi St. Chamran Blvd Shiraz Fars Iran (Islamic Republic of)