Oral FrailtyOMCDTNCT07733726
Oral Motor and Cognitive Dual-Task Training (OMCDT) Program for Improving Oral and Cognitive Functions Among People With Oral Frailty
A study testing Oral Motor and Cognitive Dual-Task Training (OMCDT) and Oral motor exercise in people with Oral Frailty and Mild Cognitive Impairment (MCI), run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Oral Frailty, Mild Cognitive Impairment (MCI), Moderate Cognitive Impairment
- What is being tested?
- Oral Motor and Cognitive Dual-Task Training (OMCDT) and Oral motor exercise
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 May 2026to 15 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
- Being tested
- Oral Motor and Cognitive Dual-Task Training (OMCDT), Oral motor exercise
- Keywords
- Oral function, Cognition, Dual task training, Elderly
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Oral motor exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 16-week; 32-week
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 16-week, 32-week
Global cognitive status
The total score of Hong Kong Version of Montreal Cognitive Assessment (HK-MoCA)
Measured: 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)
Measured: 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.).
Measured: baseline; 16-week; 32-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start1 May 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07733726
- Sponsor's protocol ID
- P0058617
- Other IDs
- P0058617
- Acronym
- OMCDT
- Status last verified
- Oct 2025
- First submitted
- 29 Jun 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Motor and Cognitive Dual-Task Training (OMCDT) Program for People With Oral Frailty for Improving Oral and Cognitive Functions: a Feasibility Study
- ClinicalTrials.gov ID
- NCT07733726
- Acronym / sponsor ID
- OMCDT / P0058617
- Keywords
- Oral function, Cognition, Dual task training, Elderly
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oral Motor and Cognitive Dual-Task Training (OMCDT) intervention group | Experimental | Other: Oral Motor and Cognitive Dual-Task Training (OMCDT)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. |
| Control Group | No intervention | –The participants in the control group will receive usual care |
| Oral motor exercise group | Experimental | Behavioral: Oral motor exerciseParticipants 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Oral Motor and Cognitive Dual-Task Training (OMCDT) intervention group |
| Oral motor exerciseThe 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. | Behavioural | Oral motor exercise group |
Primary outcome
Proportion of participant randomized divided by proportion of people eligible
Time frame: 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
Time frame: 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
Time frame: 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.
7 secondary outcomes
Maximum tongue pressure
Time frame: Baseline, 16-week, 32-week
Oral motor coordination
Time frame: baseline; 16-week; 32-week
Masticatory ability
Time frame: baseline; 16-week; 32-week
Self-reported oral health
Time frame: Baseline, 16-week, 32-week
Global cognitive status
Time frame: Baseline, 16-week, 32-week
Executive function
Time frame: baseline; 16-week; 32-week
Memory
Time frame: baseline; 16-week; 32-week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Motor and Cognitive Dual-Task Training (OMCDT) and Oral motor exercise in people with Oral Frailty and Mild Cognitive Impairment (MCI), run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participant randomized divided by proportion of people eligible (time frame: Week 16; Week-32). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.