Oral Motor and Cognitive Dual-Task Training (OMCDT) Program for Improving Oral and Cognitive Functions Among People With Oral Frailty

Официальное название

Oral Motor and Cognitive Dual-Task Training (OMCDT) Program for People With Oral Frailty for Improving Oral and Cognitive Functions: a Feasibility Study

Обзор

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

Вмешательства

• Другое Oral Motor and Cognitive Dual-Task Training (OMCDT)
  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.
• Поведенческое Oral motor exercise
  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.

Первичные конечные точки

• Proportion of participant randomized divided by proportion of people eligible [Срок оценки: Week 16; Week-32]
• Number of participants that withdraw divided by number of participants randomized [Срок оценки: 16-week; 32-week]
• Proportion of participants who complete the allocated intervention with a minimum of 80% attendance [Срок оценки: 16-week; 32-week]

Вторичные конечные точки (7)

• Maximum tongue pressure [Срок оценки: Baseline, 16-week, 32-week]
• Oral motor coordination [Срок оценки: baseline; 16-week; 32-week]
• Masticatory ability [Срок оценки: baseline; 16-week; 32-week]
• Self-reported oral health [Срок оценки: Baseline, 16-week, 32-week]
• Global cognitive status [Срок оценки: Baseline, 16-week, 32-week]
• Executive function [Срок оценки: baseline; 16-week; 32-week]
• Memory [Срок оценки: baseline; 16-week; 32-week]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

• The Hong Kong Polytechnic University — Kowloon

Идентификаторы

NCT: NCT07733726 · P0058617 · P0058617

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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