UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036682 |
|---|---|
| Receipt number | R000041781 |
| Scientific Title | Relationship between maximum retention and oral function |
| Date of disclosure of the study information | 2019/07/01 |
| Last modified on | 2022/11/09 17:33:54 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Relationship between maximum retention and oral function
Acronym
Relationship between maximum retention and oral function
Scientific Title
Relationship between maximum retention and oral function
Scientific Title:Acronym
Relationship between maximum retention and oral function
Region
| Japan |
Condition
Condition
patients 60 years of age and older
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Cardiology | Pneumology | Endocrinology and Metabolism |
| Hematology and clinical oncology | Nephrology | Neurology |
| Clinical immunology | Infectious disease | Geriatrics |
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Vascular surgery | Chest surgery | Endocrine surgery |
| Oto-rhino-laryngology | Orthopedics | Urology |
| Oral surgery | Neurosurgery | Cardiovascular surgery |
| Emergency medicine | Intensive care medicine | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the relationship between the maximum force that can hold the gauze in the tongue and palate, the maximum tongue pressure, the tongue lateral movement, oral diadochonexiasis, and the tongue pressure during swallowing, and the maximum retention force is the oral cavity. It is to clarify that it is an index that reflects the function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Maximum retention( Maximum power to hold the gauze in the tongue and palate )
Key secondary outcomes
Maximum tongue pressure value measured by JMS
The tongue pressure value of the saliva effort swallowing measured by Swallowscan
Acoustic analysis of Oral Diadochokinesis
Left and right repetitive movement of the tongue
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Oral Function Deterioration Group (Utanohara et al. Maximum age-specific tongue pressure below average)
Oral function normal group (Utanohara et al. Age-specific maximum tongue pressure is above average)
Interventions/Control_2
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
| 60 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients aged 60 or older in Hyogo College Of Medicine Hospital. Patients who is able to understand instructions of opening mouth, tongue thrust and tongue elevation. Patients whose blood pressure, heart rate and oxygen saturation are below the required standards for rehabilitation at rest, during and after exercise.
Key exclusion criteria
Structural disorder of the palate, tongue, jaw. Patients with dementia, aphasia, severe dysphagia, oral musitis and gingival recession.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kazuhisa |
| Middle name | |
| Last name | Domen |
Organization
Hyogo collage of medicine
Division name
Department of rehabilitation
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL
0798-45-6644
office@craseed.org
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Horikawa |
Organization
Hospital of Hyogo College of Medicine
Division name
Department of physical medicine and rehabilitation
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL
0798-45-6345
Homepage URL
ko-horikawa@hyo-med.ac.jp
Sponsor or person
Institute
Hospital of Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo Medical University Clinical Research Support Center
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
Tel
0798456006
chiken02@hyo-med.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
file:///C:/Users/horikawa/Desktop/%E5%A4%A7%E5%AD%A6%E9%99%A2/%E5%80%AB%E7%90%86%E5%AF%A9%E6%9F%BB%E
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
37
Results
The maximal holding power was significantly correlated with the maximal tongue pressure, the tongue pressure during forced swallowing, the number of repetitions for 5 seconds in the left and right movement of the tongue, and the number of repetitions for 5 seconds in / ta / oral diadochokinesis. The intra-rater reliability of maximal retention was 0.85 for a single measurement and 0.95 for an average, and the inter-rater reliability was 0.93 for an average.
Results date posted
| 2020 | Year | 12 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The breakdown of the diagnosed names of all subjects was cerebrovascular disorder in 6, neuromuscular disease in 15, heart disease in 4, cancer in 7, pneumonia in 3, and 2 others. The average maximal holding power is 2.2kg (male: 2.0kg, female: 2.3kg), and the average maximal tongue pressure is 22.7kPa (male: 21.4kPa, female: 24.4).
Participant flow
Adverse events
none
Outcome measures
1) Maximal holding power
2) Maximal tongue pressure
3) Tongue pressure during swallowing
4) The number of oral diadochokinesis
5) Left and right movement of the tongue
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 02 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 11 | Month | 09 | Day |
Date trial data considered complete
| 2022 | Year | 11 | Month | 09 | Day |
Date analysis concluded
| 2022 | Year | 11 | Month | 09 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 05 | Month | 08 | Day |
Last modified on
| 2022 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041781
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
