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
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Kowloon, Hong Kong
- The Hong Kong Polytechnic University
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
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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.
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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.
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Sin intervención: Control Group
The participants in the control group will receive usual care
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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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Proportion of participant randomized divided by proportion of people eligible
Periodo de tiempo: Week 16; Week-32
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Recruitment rate will be assessed by calculating the proportion of participant randomized divided by proportion of people eligible.
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Week 16; Week-32
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Number of participants that withdraw divided by number of participants randomized
Periodo de tiempo: 16-week; 32-week
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Attrition rate will be assessed by calculating the number of participants that withdraw divided by number of participants randomized
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16-week; 32-week
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Proportion of participants who complete the allocated intervention with a minimum of 80% attendance
Periodo de tiempo: 16-week; 32-week
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Intervention completion rate will be assessed by calculating the proportion of participants who complete the allocated intervention with a minimum of 80% attendance.
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16-week; 32-week
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Maximum tongue pressure
Periodo de tiempo: Baseline, 16-week, 32-week
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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.
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Baseline, 16-week, 32-week
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Oral motor coordination
Periodo de tiempo: baseline; 16-week; 32-week
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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.
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baseline; 16-week; 32-week
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Masticatory ability
Periodo de tiempo: baseline; 16-week; 32-week
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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.
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baseline; 16-week; 32-week
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Self-reported oral health
Periodo de tiempo: Baseline, 16-week, 32-week
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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.
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Baseline, 16-week, 32-week
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Global cognitive status
Periodo de tiempo: Baseline, 16-week, 32-week
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The total score of Hong Kong Version of Montreal Cognitive Assessment (HK-MoCA)
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Baseline, 16-week, 32-week
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Executive function
Periodo de tiempo: baseline; 16-week; 32-week
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The time in second used by completing the Trail Making Test Part A (TMT-A) and Part B (TMT-B)
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baseline; 16-week; 32-week
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Memory
Periodo de tiempo: baseline; 16-week; 32-week
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The score of Fuld Object Memory Evaluation and Modified Verbal Fluency Test (F.O.M.E.
& M.V.F.T.).
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baseline; 16-week; 32-week
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- P0058617 (Otro número de subvención/financiamiento: Start-up Fund for RAPs under the Strategic Hiring Scheme)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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