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
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 장소
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Kowloon, 홍콩
- The Hong Kong Polytechnic University
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: 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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간섭 없음: Control Group
The participants in the control group will receive usual care
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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportion of participant randomized divided by proportion of people eligible
기간: 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
기간: 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
기간: 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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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Maximum tongue pressure
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- P0058617 (기타 보조금/기금 번호: Start-up Fund for RAPs under the Strategic Hiring Scheme)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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