Oral Motor and Cognitive Dual-Task Training (OMCDT) Program for People With Oral Frailty for Improving Oral and Cognitive Functions: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Proportion of participant randomized divided by proportion of people eligible
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
After getting the consent of the participants, participants will be randomly assigned to two different groups using computer-generated numbers. The allocation will be carried out by using the closed-envelope method. The research assistant involved in assessing the outcome will be blinded to the allocation. The allocation will be released after completing the baseline data collection.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Proportion of participant randomized divided by proportion of people eligible
时间窗: Week 16; Week-32
Recruitment rate will be assessed by calculating the proportion of participant randomized divided by proportion of people eligible.
Number of participants that withdraw divided by number of participants randomized
时间窗: 16-week; 32-week
Attrition rate will be assessed by calculating the number of participants that withdraw divided by number of participants randomized
Proportion of participants who complete the allocated intervention with a minimum of 80% attendance
时间窗: 16-week; 32-week
Intervention completion rate will be assessed by calculating the proportion of participants who complete the allocated intervention with a minimum of 80% attendance.
次要结局
- Maximum tongue pressure(Baseline, 16-week, 32-week)
- Oral motor coordination(baseline; 16-week; 32-week)
- Masticatory ability(baseline; 16-week; 32-week)
- Self-reported oral health(Baseline, 16-week, 32-week)
- Global cognitive status(Baseline, 16-week, 32-week)
- Executive function(baseline; 16-week; 32-week)
- Memory(baseline; 16-week; 32-week)