UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055386 |
|---|---|
| Receipt number | R000063271 |
| Scientific Title | Effects of kyphosis on oral function in the elderly: A study of oral care suitable for the elderly with kyphosis and forward head posture. |
| Date of disclosure of the study information | 2024/09/01 |
| Last modified on | 2025/03/01 11:39:37 |
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Basic information
Public title
Effects of kyphosis on oral function in the elderly: A study of oral care suitable for the elderly with kyphosis and forward head posture.
Acronym
Oral function and oral care in elderly patients with kyphosis
Scientific Title
Effects of kyphosis on oral function in the elderly: A study of oral care suitable for the elderly with kyphosis and forward head posture.
Scientific Title:Acronym
Oral function and oral care in elderly patients with kyphosis
Region
| Japan |
Condition
Condition
dysphagia
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Kyphosis is an abnormal posture frequently observed in clinical practice and increases with age. The number of elderly patients with kyphosis is expected to increase in Japan, a super-aged society. According to previous studies, elderly patients with kyphosis have decreased respiratory function, decreased tongue pressure, and decreased muscle activity of the suprahyoid muscles and infrahyoid muscles, which may affect swallowing function (Uchida et al., 2023), (Ito et al., 2007). Regarding the relationship with oral function, the relationship between forward head posture and jaw-opening force, which are compensatory movements of the kyphosis, has only been suggested (Tamai et al., 2022). To our knowledge, there have been no reports on the evaluation of oral function in elderly patients with kyphosis and its relevance. The purpose of this study was to evaluate whether or not the presence or absence of kyphosis affects oral function in the elderly and to examine effective oral care methods.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oral function (oral dryness, tongue and lip motor function, tongue pressure, amount of mouth opening and swallowing function) after 2 weeks of intervention by a speech-language pathologist
Key secondary outcomes
Basic Information
Gender, age, height, weight, BMI (Body Mass Index)
Medical information
Number of remaining teeth, dentures, underlying diseases, complications, inflammation values (WBC, CRP), nutritional values (TP, ALB), residence before admission, time from admission to SLP intervention, number of days in hospital
Kyphosis
During the first evaluation, the patient's Kyphosis index (KI) and craniovertebral angle (CVA), a measure of forward head posture, are measured (Milne et al., 1974), (Tamai et al., 2022). In this study, KI13 or higher is determined as kyphosis with reference to a study of Japanese subjects and classified into two groups: non-kyphosis group and kyphosis group (Yanagida et al., 2015).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The subject's kyphoscoliosis index (KI) and craniovertebral angle (CVA), an indicator of forward head posture, are measured at the initial evaluation by the speech-language pathologist (SLP) (Milne et al., 1974) ,(Tamai et al., 2022). In this study, we determine KI13 or higher as kyphoscoliosis with reference to studies on Japanese subjects and classify them into two groups: non-scoliosis group and scoliosis group (Yanagida et al., 2015). Both groups will receive functional oral care with SLP for 2 weeks. In this study, revised oral assessment guide, oral moisture tester mucus, oral diadochokinesis, tongue pressure measurement, measurement of mouth opening capacity, and food intake level scale will be performed to measure oral function at the initial SLP evaluation and on the last intervention day of the second week. In addition to the SLP, the primary physician and nurse were asked to cooperate in the evaluation, and the evaluation was done in consultation with the three parties.
Interventions/Control_2
same
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The subject was an elderly patient admitted to the general ward of Hospital A and rehabilitated by SLP with a diagnosis of dysphagia.
The following five criteria were selected: 1. late-elderly patients aged 75 years or older; 2. patients with a Barthel Index score of 0/100 and full assistance in ADLs, who have difficulty in independent oral care; 3. patients with no organic damage requiring acute treatment such as fracture, dislocation, or muscle tear in the trunk and neck; 4. patients with maxillofacial and oral diseases that do not require dental treatment; and 5. patients with no acute cerebrovascular disease on imaging findings. The patients who fulfill all five criteria will be selected.
Key exclusion criteria
Patients who significantly refuse oral care assistance due to severe dementia, post-ischemic cerebrovascular disease, or psychiatric disorders.
Patients undergoing tracheal intubation and non-invasive positive pressure ventilation as treatment for acute respiratory failure.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Akihiro |
| Middle name | |
| Last name | Sugiyama |
Organization
Public Interest Incorporated Association Yuurinkouseikai, Fuji Hospital
Division name
Department of Rehabilitation
Zip code
412-0043
Address
1784 Niihashi, Gotemba City, Shizuoka Prefecture, Japan
TEL
09056228342
st_god_hand_alfa147bl@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | |
| Last name | Sugiyama |
Organization
Public Interest Incorporated Association Yuurinkouseikai, Fuji Hospital
Division name
Department of Rehabilitation
Zip code
412-0043
Address
1784 Niihashi, Gotemba City, Shizuoka Prefecture, Japan
TEL
0550833333
Homepage URL
st_god_hand_alfa147bl@yahoo.co.jp
Sponsor or person
Institute
Public Interest Incorporated Association Yuurinkouseikai, Fuji Hospital
Institute
Department
Personal name
Akihiro Sugiyama
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
Public Interest Incorporated Association Yuurinkouseikai, Fuji Hospital
Address
1784 Niihashi, Gotemba City, Shizuoka Prefecture, Japan
Tel
0550833333
st_god_hand_alfa147bl@yahoo.co.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
公益社団法人有隣厚生会富士病院(静岡県)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
49
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2025 | Year | 02 | Month | 28 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 31 | Day |
Last modified on
| 2025 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063271
