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

23. juli 2026 oppdatert av: The Hong Kong Polytechnic University

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

Studieoversikt

Status

Påmelding etter invitasjon

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

66

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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).

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Annen: 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.
Ingen inngripen: Control Group
The participants in the control group will receive usual care
Eksperimentell: 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.
Atferdsmessig: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion of participant randomized divided by proportion of people eligible
Tidsramme: Week 16; Week-32
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
Tidsramme: 16-week; 32-week
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
Tidsramme: 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.
16-week; 32-week

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Maximum tongue pressure
Tidsramme: Baseline, 16-week, 32-week
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
Tidsramme: baseline; 16-week; 32-week
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
Tidsramme: baseline; 16-week; 32-week
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
Tidsramme: Baseline, 16-week, 32-week
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
Tidsramme: Baseline, 16-week, 32-week
The total score of Hong Kong Version of Montreal Cognitive Assessment (HK-MoCA)
Baseline, 16-week, 32-week
Executive function
Tidsramme: baseline; 16-week; 32-week
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
Tidsramme: baseline; 16-week; 32-week
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

The Hong Kong Polytechnic University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mai 2026

Primær fullføring (Antatt)

30. desember 2026

Studiet fullført (Antatt)

15. juni 2027

Datoer for studieregistrering

Først innsendt

29. juni 2026

Først innsendt som oppfylte QC-kriteriene

23. juli 2026

Først lagt ut (Faktiske)

29. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. juli 2026

Sist bekreftet

1. oktober 2025

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • P0058617 (Annet stipend/finansieringsnummer: Start-up Fund for RAPs under the Strategic Hiring Scheme)

Plan for individuelle deltakerdata (IPD)

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NEI

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Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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