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Jan. 24, 2020

Nov. 14, 2022

jRCTs032190193

Effects of exercise with tongue training tool on the oral function of dementia patients living in nursing homes: a randomized open trial

Effects of exercise with tongue training tool on the oral function of dementia patients living in nursing homes

Oct. 21, 2020

19

The age range was 70s to 90s, 11 subjects in the intervention group (4 males, 7 females) and 8 subjects in the control group (2 males, 6 females).

Of the assigned subjects, two dropouts were identified in the control group; the others completed the study.

No adverse events were in this study.

In this study, tongue pressure was set as the primary outcome of efficacy. Comparing geometric means, tongue pressure in the intervention group was significantly higher than that in the control group from 4 weeks after the start of tongue pressure training (4w), 8 weeks after the start of tongue pressure training (8w), and 12 weeks after the start of tongue pressure training (12w). The ratios and their 95% confidence intervals (CI) of the estimated geometric means around each assessment time point were 1.4 (95%CI: 1.1-1.9) for 4w, 1.5 (95%CI: 1.1-2.0) for 8w, and 1.4 (95%CI: 1.0-1.9) for 12w. For ODKs "Pa" and "Ta," the intervention group was significantly higher than the control group at 12w, with the ratio of estimated peripheral geometric means and its 95% CI being 1.2 (95%CI: 1.0-1.3) for "Pa" and 1.2 (95%CI: 1.0-1.3) for "Ta" respectively.

The results of this study indicated that continuous tongue pressure training using the PecoPanda could improve the tongue pressure of the subjects. It was also thought that the use of PecoPanda strengthened the muscles necessary to pronounce "pa" and "ta," resulting in easier pronunciation of those sounds.

Sept. 22, 2022

No

No data sharing is planned.

https://jrct.mhlw.go.jp/latest-detail/jRCTs032190193

Hamajima Takuya

Medical Corporation Shinseikai

266 Takagi, Nishi-ku, Saitama-shi, Saitama, Japan

+81-48-625-7581

takuya-hamajima@shinsei-gr.com

Suzuki Naoko

ORTHOMEDICO Inc.

2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo

+81-3-3818-0610

nao@orthomedico.jp

Complete

Jan. 24, 2020

April. 16, 2020
22

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

prevention purpose

1. Subjects aged 65 or over who were diagnosed with dementia and were living in nursing homes where Medical Corporation Shinseikai involves in intraoral care
2. Subjects who are judged as eligible to participate in the study by the principal investigator
3. Subjects whose maximum tongue pressure is less than 30 kPa at screening (baseline)
4. If number of people whose maximum tongue pressure is less than 30 kPa at screening (baseline) exceed the sample size, select subjects with relatively low value in maximum tongue pressure

1. Subjects who are ineligibility to participate in the study based on the evaluation of the principal investigator

65age old over
No limit

Both

dementia

Active group: Intervention 1 + Intervention 2
Control group: Intervention 1

Intervention 1: Oral care program
Intervention 2: Tongue training with Peko-panda (JMS Co., Ltd.) is performed twice a week, 3 sets of less than 6 times/set

maximum tongue pressure

repetitive saliva swallowing test (RSST), oral diadochokinetic (ODK) rate, oral assessment, Geriatric Oral Health Assessment Index (GOHAI)

ORTHOMEDICO Inc.
Applicable
Takara Clinic Certified Review Board
9F Taisei Bldg., 2-3-2 Higashi-gotanda, Shinagawa-ku, Tokyo, Tokyo

+81-3-5793-3623

irb@takara-clinic.com
Approval

Dec. 03, 2019

none

History of Changes

No Publication date
4 Nov. 14, 2022 (this page) Changes
3 April. 13, 2022 Detail Changes
2 May. 13, 2020 Detail Changes
1 Jan. 24, 2020 Detail