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

NCT07733726 | Enrolling By Invitation

• 1 other identifier: P0058617
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Oral Frailty; Mild Cognitive Impairment (MCI); Moderate Cognitive Impairment

Keywords

Oral function; Cognition; Dual task training; Elderly

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• 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

Study Arms (3)

Oral Motor and Cognitive Dual-Task Training (OMCDT) intervention group

EXPERIMENTAL

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)

Control Group

NO INTERVENTION

The participants in the control group will receive usual care

Oral motor exercise group

EXPERIMENTAL

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

Interventions

Oral Motor and Cognitive Dual-Task Training (OMCDT) OTHER

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.

Oral Motor and Cognitive Dual-Task Training (OMCDT) intervention group

Oral motor exercise BEHAVIORAL

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.

Oral motor exercise group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Kowloon, Hong Kong

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 29, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): June 15, 2027
• Last Updated: July 29, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)