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临床试验/NCT05678686
NCT05678686已完成不适用

Investigation of The Effects of Different Exercise Methods on Swallowing Function in Stroke Patients

Karamanoğlu Mehmetbey University1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2022年10月3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
发起方
入组人数
42
试验地点
1
主要终点
Ultrasound Evaluation

研究概览

简要总结

The aim of this study is to examine the effects of PNF (proprioceptive neuromuscular facilitation) and CTAR (Chin Tuck Against Resistance) exercises on swallowing rehabilitation in stroke patients. In addition another aim is to examine the effects of these exercises on the swallowing function, quality of life, functional independence and functional oral intake of individuals, and to investigate the superiority of the exercises to each other in line with these features.

研究设计

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

盲法说明

The physicians who will evaluate imaging methods will not know which arm they are in. In addition patricipants will not know which arm they are in.

入排标准

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

入选标准

  • •18 years and older,
  • •Who have been diagnosed with stroke
  • •At least one month has passed since the diagnosis of stroke
  • •Voluntarily participated in the research,
  • •Cooperative, able to take instructions (Mini Mental Test score of 24 and above) and
  • •Individuals with a score of 2 or higher on the Penetration Aspiration Scale will be included.

排除标准

  • •Lack of long-term sitting balance, unable to maintain an upright position with or without support,
  • •Have tumors or neoplastic disease in the head and neck region,
  • •Radiotherapy applied to the neck, swallowing disorders caused by radiotherapy applied to the head and neck region,
  • •With additional musculoskeletal disease that may cause swallowing disorders,
  • •With non-stroke neurological disease (Traumatic Brain Injury, Parkinson's, Dementia, ALS, MS, etc.),
  • •Individuals who have previously received dysphagia treatment will be excluded from the study.

研究组 & 干预措施

Routine Exercise Group

Active Comparator

Conventional swallowing therapy exercises will be given to the routine exercise group.

干预措施: Active Comparator: Routine Exercise Group (Other)

PNF Exercise

Experimental

Head-neck PNF (Proprioceptive Neuromuscular Facilitation) movement patterns will be applied to the participants with the combined isometric contraction technique.

干预措施: Experimental: PNF Exercise (Other)

CTAR Exercise

Experimental

CTAR (Chin Tuck Against Resistance) exercises will be applied to the participants.

干预措施: Experimental: CTAR Exercise (Other)

结局指标

主要结局

Ultrasound Evaluation

时间窗: Change from baseline at 8 weeks

Neck submental muscle cross-sectional thickness measurement (millimeter-mm), sternocleidomastoideus muscle thickness measurement (mm), hyoid bone elevation measurement (millimeter-mm) and tongue base cross-sectional area (square-centimeter-cm2) will be measured by USG before and after therapy. USG measurements will be made by an experienced radiologist. Three measurements will be taken from each muscle group and the results will be averaged to minimize variations in muscle thickness.

Penetration Aspiration Scale (PAS)

时间窗: Change from baseline at 8 weeks

The penetration aspiration scale (PAS) is routinely used to assess penetration and aspiration severity during videofluoroscopic or FEES assessment. It has a scoring system from 0 to 8, depending on whether it is aspirated or penetrated after administration of liquid-consistent and solid foods with oral contrast agent or dye. High scores indicate the presence of aspiration and penetration.

次要结局

  • Cognitive Status(a day before the start of treatment)
  • The Barthel Index(Change from baseline at 8 weeks)
  • Swallowing Quality Of Life Questionnaire (SWAL-QOL)(Change from baseline at 8 weeks)
  • Eating Assessment Tool (EAT-10)(Change from baseline at 8 weeks)
  • Functional Oral Intake Scale (FOIS)(Change from baseline at 8 weeks)

研究者

发起方
Karamanoğlu Mehmetbey University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Esra Nur ÖZCAN

Lecturer

Karamanoğlu Mehmetbey University

研究点 (1)

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