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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Mild Cognitive Impairment (MCI); Moderate Cognitive Impairment; Oral Frailty
• Intervention / Treatment: Other: Oral Motor and Cognitive Dual-Task Training (OMCDT); Behavioral: Oral motor exercise

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Kowloon, Hong Kong
    • The Hong Kong Polytechnic University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adults aged 50 years or above;
2. Cantonese speaking;
3. 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;
4. 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;
5. Living independently or with partial assistance, defined as a score of Modified Barthel Index score greater than 60 out of 100;
6. Right-handed person to minimize variability in cortical activation patterns during fNIRS measurement;
7. Can understand the purpose and contents of this project and could give written consent.

Exclusion Criteria:

1. 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;
2. Have received other cognitive training in previous 6 month;
3. Have impaired vision or hearing capacity that cannot understand the training instructions;
4. Have a diagnosis of a neurological or psychiatric condition that could affect cognitive function;
5. Have terminal illness, Temporomandibular joint dysfunction (TMJ) disorders; Sjogren's (SHOW-grins) syndrome;
6. Have undergone glossectomy surgery;
7. have been taking drugs that affect cognitive function (e.g. Benzodiazepines, antidepressants, central nervous drugs).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
No Intervention: Control Group; The participants in the control group will receive usual care
Experimental: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participant randomized divided by proportion of people eligible	Recruitment rate will be assessed by calculating the proportion of participant randomized divided by proportion of people eligible.	Week 16; Week-32
Number of participants that withdraw divided by number of participants randomized	Attrition rate will be assessed by calculating the number of participants that withdraw divided by number of participants randomized	16-week; 32-week
Proportion of participants who complete the allocated intervention with a minimum of 80% attendance	Intervention completion rate will be assessed by calculating the proportion of participants who complete the allocated intervention with a minimum of 80% attendance.	16-week; 32-week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum tongue pressure	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.	Baseline, 16-week, 32-week
Oral motor coordination	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.	baseline; 16-week; 32-week
Masticatory ability	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.	baseline; 16-week; 32-week
Self-reported oral health	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.	Baseline, 16-week, 32-week
Global cognitive status	The total score of Hong Kong Version of Montreal Cognitive Assessment (HK-MoCA)	Baseline, 16-week, 32-week
Executive function	The time in second used by completing the Trail Making Test Part A (TMT-A) and Part B (TMT-B)	baseline; 16-week; 32-week
Memory	The score of Fuld Object Memory Evaluation and Modified Verbal Fluency Test (F.O.M.E. & M.V.F.T.).	baseline; 16-week; 32-week

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): June 15, 2027

Study Registration Dates

• First Submitted: June 29, 2026
• First Submitted That Met QC Criteria: July 23, 2026
• First Posted (Actual): July 29, 2026

Study Record Updates

• Last Update Posted (Actual): July 29, 2026
• Last Update Submitted That Met QC Criteria: July 23, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Elderly; Cognition; Dual task training; Oral function
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: P0058617 (Other Grant/Funding Number: Start-up Fund for RAPs under the Strategic Hiring Scheme)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No