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临床试验/NCT05503420
NCT05503420Unknown2 期

Randomized Controlled Trial on Effects of Masticatory Muscles Training Exercises on the Masticatory Performance and Rehabilitation of Stroke Patients

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2021年10月1日最近更新:
适应症

试验速览

阶段
2 期
入组人数
96
试验地点
1
主要终点
masticatory performance

研究概览

简要总结

Stroke is one of the top causes of death and morbidity of adults, especially the older population in the economically developed countries. People who survives from stroke attack usually suffer from a wide range of impairments and often have poor chewing ability even when they are physically well enough to be discharged from hospital. Aim of this proposed study is to investigate the effects of providing masticatory muscles training exercises on the masticatory performance, nutrition intake and general health conditions of stroke rehabilitation patients. Around 100 stroke patients undergoing rehabilitation in the rehabilitation centre in Tung Wah Eastern Hospital, Hong Kong, will be recruited and allocated randomly into one of two study groups: Group 1 will be provided with an oral device for chewing muscles exercises and training exercises on chewing (the intervention group); and Group 2 will just follow the current stroke rehabilitation programme which does not have any training in chewing (a negative control group). A video on the chewing muscles exercises will be produced and placed online for the participants in Group 1 to view on demand. Data from the participants in both groups will be collected at four time points: at baseline before provision of the interventions, and at around 1, 3 and 6 months after the intervention. Each participant will be interviewed by a trained interviewer and undergo a clinical examination. The information collected will include the participant's oral health status such as numbers of decayed teeth and occluding tooth pairs, and their masticatory performance measured both objectively by chewing on a colour-changeable gum and subjectively by a chewing function questionnaire. Their type of stroke (ischemic or hemorrhagic) and general health conditions such as physical function status and nutrition intake will be recorded. The masticatory performance and general health conditions of the two groups of study participants at baseline and follow-up evaluations will be compared to assess if the masticatory muscles training exercises can improve the rehabilitation outcomes. It is anticipated that this proposed randomized trial will provide high-level clinical evidence to support the introduction of masticatory muscles training exercises into the rehabilitation programme of stroke patients and to inform how the exercises will benefit the patients, such as improving their chewing ability and general health conditions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Investigator)

入排标准

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

入选标准

  • aged 30 years or above, first-time stroke patient within 20 days post-stroke and medical status being stable

排除标准

  • unable to follow basic instructions, unable to communicate clearly, being bed-ridden, dysphagic (on nasogastric tube) and not having any natural teeth in either of the jaws

结局指标

主要结局

masticatory performance

时间窗: 6 months

colour of a color-changeable gum after chewing for 90 seconds measured in a\* value

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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