Oral Motor and Cognitive Dual-Task Training (OMCDT) Program for Improving Oral and Cognitive Functions Among People With Oral Frailty (OMCDT)
2026年7月23日 更新者:The Hong Kong Polytechnic University
Oral Motor and Cognitive Dual-Task Training (OMCDT) Program for People With Oral Frailty for Improving Oral and Cognitive Functions: a Feasibility Study
The goal of this clinical trial is to proposes a novel Oral Motor and Cognitive Dual-Task Training (OMCDT) program that combines both oral motor exercises and cognitive tasks to improve brain and oral function at the same time. It will also learn about the safety of drug ABC. The main questions it aims to answer is:
Does the OMCDT training can improve the oral and cognitive functions?
Participants will:
Take the OMCDT training once a week for 32 weeks Visit the lab twice in the intervention period (16-week, 32-week) for checkups and tests
研究概览
地位
邀请报名
研究类型
介入性
注册 (估计的)
66
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Kowloon、香港
- The Hong Kong Polytechnic University
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Adults aged 50 years or above;
- Cantonese speaking;
- Having oral frailty, which is defined as having at least two of the following components by Oral Frailty Five-item Checklist (OF-5): (i) Natural teeth fewer than 20, (ii) Have any difficulties eating tough foods now compared with 6 months ago; (iii) Have choked on tea or soup recently; (iv) Often experience having a dry mouth, and (v) Oral diadochokinetic /ta/ sound <6.0 times/second;
- Having subjective cognitive decline (SCD), which refers to self-reported experience of worsening or more frequent confusion or memory loss in the past 12 month, or having been diagnosed with mild or moderate cognitive impairment; defined as a score of 0.5, 1, or 2 on Clinical Dementia Rating (C.D.R) scale;
- Living independently or with partial assistance, defined as a score of Modified Barthel Index score greater than 60 out of 100;
- Right-handed person to minimize variability in cortical activation patterns during fNIRS measurement;
- Can understand the purpose and contents of this project and could give written consent.
Exclusion Criteria:
- Have attended the dental clinics for dental treatment or received orofacial myofunctional therapy (OMT), involving doing certain oral exercises with cheeks, tongue, or lips in previous 6 months;
- Have received other cognitive training in previous 6 month;
- Have impaired vision or hearing capacity that cannot understand the training instructions;
- Have a diagnosis of a neurological or psychiatric condition that could affect cognitive function;
- Have terminal illness, Temporomandibular joint dysfunction (TMJ) disorders; Sjogren's (SHOW-grins) syndrome;
- Have undergone glossectomy surgery;
- have been taking drugs that affect cognitive function (e.g. Benzodiazepines, antidepressants, central nervous drugs).
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Oral Motor and Cognitive Dual-Task Training (OMCDT) intervention group
The participants will be instructed to relax as much as possible, and the surrounding environment will be set up as monotonous as possible.
Only one PC, one (NIRS) with its accessories will be placed on a table.
Particularly, at Week 1, Week 16 and Week 32, participants will be instructed to sit in a comfortable chair in front of the PC and wear the NIRS device.
The intervention will be carried out follow the modified OCMDT protocol.
Each weekly session includes 28 small training activities lasting about 40 min for 32 weeks.
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Oral Motor and Cognitive Dual-Task Training (OMCDT) program that combines both oral motor exercises and cognitive tasks to improve brain and oral function at the same time, where the training includes 4 types of combined oral and cognitive functions.
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无干预:Control Group
The participants in the control group will receive usual care
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实验性的:Oral motor exercise group
Participants in the oral motor exercise group will receive evidence-based oral motor exercises without cognitive training.
The intervention will include four components: tongue-lip coordination exercises, tongue muscle strengthening exercises, lip and cheek muscle strengthening exercises, and mastication exercises.
Each component will be repeated for seven rounds, with a 10-second rest interval between rounds.
The intervention will be delivered once per week.
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The intervention will include four components: tongue-lip coordination exercises, tongue muscle strengthening exercises, lip and cheek muscle strengthening exercises, and mastication exercises.
Each component will be repeated for seven rounds, with a 10-second rest interval between rounds.
The intervention will be delivered once per week.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Proportion of participant randomized divided by proportion of people eligible
大体时间:Week 16; Week-32
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Recruitment rate will be assessed by calculating the proportion of participant randomized divided by proportion of people eligible.
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Week 16; Week-32
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Number of participants that withdraw divided by number of participants randomized
大体时间:16-week; 32-week
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Attrition rate will be assessed by calculating the number of participants that withdraw divided by number of participants randomized
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16-week; 32-week
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Proportion of participants who complete the allocated intervention with a minimum of 80% attendance
大体时间:16-week; 32-week
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Intervention completion rate will be assessed by calculating the proportion of participants who complete the allocated intervention with a minimum of 80% attendance.
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16-week; 32-week
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Maximum tongue pressure
大体时间:Baseline, 16-week, 32-week
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The tongue pressure will be measured three times using a tongue pressure meter (JMS Co., Ltd., Hiroshima, Japan) and the maximum value will be recorded.
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Baseline, 16-week, 32-week
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Oral motor coordination
大体时间:baseline; 16-week; 32-week
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Cantonese-specific ODK test will be assessed by counting the number of monosyllabic, disyllabic, and trisyllabic Cantonese syllables (e.g., /bo1/, /bui1 dip6/, /bei2 daan6 gou1/) that the subject can speak out correctly over 5-second interval.
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baseline; 16-week; 32-week
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Masticatory ability
大体时间:baseline; 16-week; 32-week
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Masticatory ability will be evaluated using xylitol chewing check gum (Lotte, Tokyo, Japan).
Participants will be instructed to chew the xylitol chewing check gum for 60 seconds.
After chewing, place the gum on white paper and compare against a standardized color scale.
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baseline; 16-week; 32-week
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Self-reported oral health
大体时间:Baseline, 16-week, 32-week
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The self-reported oral health will be evaluated by General Oral Health Assessment Index (GOHAI).
the Chinese version of GOHAI include 12 items There are five response categories for each question (l=always, 2=often,3=sometimes,4=seldom,and 5=never).
The GOHAI score was computed by adding up the scores of the responses to the 12 questions and a higher score indicates a better reported oral health status.
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Baseline, 16-week, 32-week
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Global cognitive status
大体时间:Baseline, 16-week, 32-week
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The total score of Hong Kong Version of Montreal Cognitive Assessment (HK-MoCA)
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Baseline, 16-week, 32-week
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Executive function
大体时间:baseline; 16-week; 32-week
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The time in second used by completing the Trail Making Test Part A (TMT-A) and Part B (TMT-B)
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baseline; 16-week; 32-week
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Memory
大体时间:baseline; 16-week; 32-week
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The score of Fuld Object Memory Evaluation and Modified Verbal Fluency Test (F.O.M.E.
& M.V.F.T.).
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baseline; 16-week; 32-week
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年5月1日
初级完成 (估计的)
2026年12月30日
研究完成 (估计的)
2027年6月15日
研究注册日期
首次提交
2026年6月29日
首先提交符合 QC 标准的
2026年7月23日
首次发布 (实际的)
2026年7月29日
研究记录更新
最后更新发布 (实际的)
2026年7月29日
上次提交的符合 QC 标准的更新
2026年7月23日
最后验证
2025年10月1日
更多信息
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