UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032262 |
|---|---|
| Receipt number | R000036788 |
| Scientific Title | The effects of interferential current stimulation through the neck skin of dysphagia on swallowing in the residents of chronic phase facilities. |
| Date of disclosure of the study information | 2018/05/07 |
| Last modified on | 2024/11/27 16:51:17 |
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Basic information
Public title
The effects of interferential current stimulation through the neck skin of dysphagia on swallowing in the residents of chronic phase facilities.
Acronym
The effects of interferential current stimulation through the neck skin of dysphagia on swallowing in the residents of chronic phase facilities.
Scientific Title
The effects of interferential current stimulation through the neck skin of dysphagia on swallowing in the residents of chronic phase facilities.
Scientific Title:Acronym
The effects of interferential current stimulation through the neck skin of dysphagia on swallowing in the residents of chronic phase facilities.
Region
| Japan |
Condition
Condition
Dysphagia
Those who are ingesting some sort of swallowing -adjusted meal(requiring special preparation)by mouth.
Classification by specialty
| Rehabilitation medicine | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
IFC(interferential current stimulation therapy)is a noninvasive therapy which does not involve muscle contraction.According to a previous study,it was found that IFC improves the swallowing reflex in healthy subjects.Also,it was found that IFC improves nutritional intake and cough sensitivity of patients in acute phase hospitals.However,there are no reports of its use in chronic phase facilities.The purpose of this study is to verify whether IFC-TESS is also effective in improving the swallowing function of those in chronic phase facilities.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Swallowing function in the residents of chronic phase facilities.
The evaluation results from before and after intervention (interference current stimulation ) will be compared.
Compare cough reflexes (cough latency time) at the beginning of intervention and 3 weeks later.
Key secondary outcomes
Evaluation of Nutrition ( FOIS , Oral intake calorie)
Cough reflex(cough frequency)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The presence or absence of cough reflexes would be checked before intervention
Interventions/Control_2
An interferential current -transcutaneous electrical sensory stimulation device (Creid Corporation,Gentle Stim)would be used on the subjects.The device would be used 2 times a day(morning and afternoon)-15 minutes each-every day(excluding weekends;5 days a week)-for a total of 3 weeks.The presence or absence of cough reflexes would be checked before intervention, and at the end of the 3 weeks intervention.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those in chronic phase facility (such as a special nursing home for the elderly),and is orally ingesting some sort of swallowing adjusted meal.
Those with who are unable to express their intent (such as those with dementia ) are NOT excluded and included in this study.Those who fall into this category are very likely to have dysphasia,and the effectiveness of the intervention on these subjects are one of the focuses of this study.
Key exclusion criteria
Those with asthma(as a prevention of induction of asthma in cough test)
Those whose diet is tube feeding,and is not ingesting anything by mouth.
Those with pacemaker placement or those with epilepsy(as IFC-TESS may have adverce effects on subjects with such conditions.However,those with stents, coil embolization,or shunts are not excluded.
Those with 28 points or more in MMSE
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Ayako |
| Middle name | |
| Last name | Nakane |
Organization
Graduate School of Medical and Dental Sciences,Tokyo Medical and Dental University
Division name
Dysphagia Rehabilitation
Zip code
113-8510
Address
1-5-45,Yushima,Bunkyo,Tokyo,JAPAN
TEL
81-3-5803-5562
fujigerd@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiko |
| Middle name | |
| Last name | Hara |
Organization
Graduate School of Medical and Dental Sciences,Tokyo Medical and Dental University
Division name
Gerodontology and Oral Rehabilitation
Zip code
113-8510
Address
1-5-45,Yushima,Bunkyo,Tokyo,JAPAN
TEL
81-3-5803-5562
Homepage URL
haragerd@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University School of Dentistry Ethics Review Committee)
Address
1-5-45, Yushima, Bunkyo, Tokyo , JAPAN
Tel
81-3-5803-5411
d-hyoka.adm@tmd.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
社会福祉法人中野区福祉サービス事業団小淀ホーム(東京都）
社会福祉法人特別養護老人ホーム好日苑（東京都）
社会福祉法人中野区福祉サービス事業団しらさぎホーム（東京都）
介護老人保健施設 音羽えびすの郷（東京都）
介護老人保健施設 池袋えびすの郷（東京都）
社会福祉法人目黒区特別養護老人ホーム東山(東京都）
介護老人保健施設 青戸こはるびの里(東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 07 | Day |
Related information
URL releasing protocol
https://drive.google.com/file/d/1A7Q8Cr4mpSef50gSmWib_B50SAev17jA/view?usp=sharing
Publication of results
Partially published
Result
URL related to results and publications
https://drive.google.com/file/d/1mCbgy1oFOoIckNRpDlskk9DnuVbn-rKm/view?usp=sharing
Number of participants that the trial has enrolled
44
Results
The oral calorie intake indicated improved nutritional state. The women initially had shorter cough latency and more frequent coughing than men. However, both groups significantly improved oral calorie intake after the intervention (p<0.05).
Results date posted
| 2024 | Year | 11 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This study aimed to ascertain the efficacy of interferential current transcutaneous electrical sensory stimulation (IFC-TESS) for treating patients with severe dementia accompanied by dysphagia who reside in long-term care facilities.
Participant flow
A comparative study was conducted before and after the intervention. Study participants were elderly people with dysphagia residing in eight long-term care facilities. All participants were on a texture-modified diet. Participants had a history of vascular dementia, degenerative dementia, or Parkinson's disease. Patients with asthma, those requiring tube feeding, those with pacemakers or epilepsy, those who missed the intervention for more than 3 days, and those with an MMSE score of 11 or higher were excluded. Of the 49 patients with severe dementia and an MMSE score of 10 or lower enrolled in the study, 44 (38 women, 6 men) were included in the final analysis.
Adverse events
NONE
Outcome measures
The cough latency time was the primary outcome . The secondary outcomes were cough frequency, Functional Oral Intake Scale (FOIS) score, and oral calorie intake. Each outcome was measured before and 3 weeks after the intervention, and the values were compared.
Plan to share IPD
The study plan and methods are available to others within the scope of patient privacy and research security. This study has been registered in the public database UMIN.
IPD sharing Plan description
The datasets used and/or analyzed during the current study are available from the corresponding author (Ayako Nakane / Department of Dysphagia Rehabilitation, Division of Gerontology and Gerodontology, Graduate School of Medical and Dental Sciences, Science Tokyo, Tokyo, Japan / a.nakane.swal@tmd.ac.jp) on reasonable request.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 06 | Month | 18 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 07 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 05 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 16 | Day |
Last modified on
| 2024 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036788
