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临床试验/NCT04569968
NCT04569968已完成不适用

Effect of Expiratory Muscle Training on Stomatognathic System in Patients With Stroke

Abant Izzet Baysal University2 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2020年8月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
146
试验地点
2
主要终点
Change in Masticatory Performance

研究概览

简要总结

Stroke affects the vital activities of daily living such as breathing and swallowing. After stroke excursion of the diaphragm reduces about 50%, and also the maximum expiratory pressure of the individual 50% or higher. Dysphagia occurs in 29% to 45% of the acute stroke cases.

详细描述

As a third leading cause of death and one of the major causes of disability, stroke still maintain its bad reputation in worldwide. Stroke owes its fame on wide range of symptoms mostly the musculoskeletal system symptoms such as spasticity, equilibrium and gait problems. Although mentioned symptoms keep their popularity devious two dysfunction caused by stroke; stomatognathic system dysfunction and respiratory dysfunction appears to change this equation. Considering the high incidence of dysphagia and the reduced cardiopulmonary capacity of the stroke patients, it seems inevitable. From this perspective aim of this study is to assess the effect of expiratory muscle training on the stomatognathic system in patients with stroke and as mentioned aid to shatter the mentioned equation.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Outcome measures will be performed by an another investigator.

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Mini mental score is 24 or higher
  • •55 years of age or higher
  • •Currently not taking respiratory muscle training
  • •Fonseca Questionnaire score is 20 or higher
  • •Onset of stroke is between 3 months and 5 years

排除标准

  • •Developed dysphagia caused by other diseases rather than stroke
  • •Repetitive stroke story
  • •Cancer in head and neck region
  • •Abdominal or thoracic surgery story
  • •Existence of neurodegenerative disease

研究组 & 干预措施

Expiratory muscle training group

Experimental

Daily expiratory muscle training for four weeks will be applied.

干预措施: Expiratory muscle training (Other)

Control group

No Intervention

Nothing will be applied except for the hospital conventional physiotherapy program.

结局指标

主要结局

Change in Masticatory Performance

时间窗: Two measurements: At the beginning and after three weeks

To assess masticatory performance of the patients, patients will be asked to chew 3 gr of peanuts with 20 chewing stroke and then spit on a sieve with 10 mesh and 1700 µm width. Then the residue will be collected and put into the centrifuge tube. After that residue will be centrifuged for 3 minutes with 1500 rpm. Same procedure will be used for the sieved content. Then this two values will be divided and recorded as a percentage for the calculation masticatory performance index.

Change in Temporomandibular Range of Motion Measurement

时间窗: Two measurements: At the beginning and after three weeks

Mandibular depression, protrusion and bilateral lateral deviation of the patients will be performed by a digital caliper. All measurements will be taken while the patients are seated with their head supported. Digital caliper will be positioned in central incisors for the mandibular depression and the protrusion. For lateral deviation first upper central incisor location in relation to the lower central incisor will be drawn by a biocompatible pen then measurement will be performed. After that, a second drawing made. Then the horizontal distance between these two points will be measured for the lateral deviation range of motion. Reference values for mandibular depression, protrusion and the lateral deviation are as follows: 40 mm, 6 mm, and 8 mm.

Change in General Oral Health Assessment Index

时间窗: Two measurements: At the beginning and after three weeks

Oral health of the patients will be assessed with general oral health assessment index. Index consists of twelve questions. Answers of these twelve questions makes up the total score. Minimum and maximum scores of the index are 12 and 60 points. Higher total scores mean higher risk of losing the general oral health.

Change in Eating Assessment Tool (EAT-10)

时间窗: Two measurements: At the beginning and after three weeks

Swallowing quality of the patients will be assessed with eating assessment tool (EAT-10). the tool has ten questions and the total score of the tool is 40 points. Minimum score is 0 point and the maximum score is 40 point. Higher total scores mean higher risk of losing the general oral health.

Change in Pain Pressure Threshold of the Masticatory Muscles

时间窗: Two measurements: At the beginning and after three weeks

Two points in the masseter muscle and two points at the temporalis muscle, in total four points will be measured for the pain pressure threshold assessment. Measurements will be taken four times from every point with two-minute intervals. Due to first measurement values are generally high, average of the last three measurements will be calculated and recorded.

Change in Craniocervical Angle Measurement

时间窗: Two measurements: At the beginning and after three weeks

Measurement will be taken while the patients are seated and their head in natural position. After that photos of the patients will be taken and then processus spinosus of the C7 and the tragus of the ear will be marked. After that, the angle between those to marking will be measured by the protractor.

Change in Repeated Saliva Swallow Test

时间窗: Two measurements: At the beginning and after three weeks

Patients will be asked to swallow their saliva as much as they can do in thirty seconds.

Change in Fonseca Questionnaire

时间窗: Two measurements: At the beginning and after three weeks

Temporomandibular joint dysfunction existence and its severity will be assessed with Fonseca Questionnaire. Questionnaire includes 10 questions with yes, sometimes and no answers matching with 10, 5, and 0 point. Total score of the questionnaire is 100 point. Categorization of dysfunction by the questionnaire as follows; 70-100 point: severe dysfunction, 45-65: moderate dysfunction, 20-40: mild dysfunction and 0-15: has no dysfunction at all.

Change in Intraoral pH Measurement

时间窗: Two measurements: At the beginning and after three weeks

Saliva of the patients will be collected between 08:00-12:00 am. After the saliva collected in centrifuge tube reaches 5 ml, collection process will be stopped and immediately pH of the saliva measured with two decimal digital pH meter

Change in Neck Flexor Endurance Test

时间窗: Two measurements: At the beginning and after three weeks

Test will be performed while the patients are in supine position. After the position is taken patient will be asked to elevate their head about one inch and keep it that way as much as they can do. The period that passes from starting to the positional alteration will be recorded as the test score.

次要结局

  • Mini Mental State Exame Test(At the enrollment process)
  • Change in Labial Commissure Angle(Two measurements: At the beginning and after three weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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