UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062107 |
|---|---|
| Receipt number | R000071063 |
| Scientific Title | Association between freezing of swallowing and dysphagia in Parkinson's disease |
| Date of disclosure of the study information | 2026/07/06 |
| Last modified on | 2026/07/01 12:48:56 |
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Basic information
Public title
Association between freezing of swallowing and dysphagia in Parkinson's disease
Acronym
FoS-PD Study
Scientific Title
Association between freezing of swallowing and dysphagia in Parkinson's disease
Scientific Title:Acronym
FoS-PD Study
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the characteristics of the difference between self-perceived and objectively measured swallowing counts in patients with Parkinson's disease, and to examine whether this difference reflects freezing of swallowing and its occurrence process, thereby evaluating the clinical significance of freezing of swallowing.
Basic objectives2
Others
Basic objectives -Others
Evaluation of the difference between self-perceived and objectively measured swallowing counts and its association with dysphagia-related measures
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference between self-perceived swallowing count and objectively measured swallowing count
Key secondary outcomes
RSST count; 100 mL water swallowing test; grip strength; EAT-10; MDS-UPDRS Part II; SDQ-J; NFOG-Q; demographic and clinical information; and Hoehn & Yahr stage
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Control group: older adults aged 60 years or older.
Experimental group: patients with Parkinson's disease aged 60 years or older who have been diagnosed according to the MDS clinical diagnostic criteria for Parkinson's disease (2015).
Key exclusion criteria
1. Individuals with a history of neuromuscular disease or cerebrovascular disease.
2. Individuals who consume food forms other than a regular diet, including chopped or blended diets.
3. Individuals who are judged to have difficulty fully understanding the study procedures and providing voluntary written informed consent.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Sumire |
| Middle name | |
| Last name | Ishiyama |
Organization
Ibaraki Prefectural University of Health Sciences
Division name
Center for Medical Sciences
Zip code
300-0394
Address
4669-2 Ami, Ami-machi, Inashiki-gun, Ibaraki, Japan
TEL
0298884000
ishiyamasu@ipu.ac.jp
Public contact
Name of contact person
| 1st name | Tetsushi |
| Middle name | |
| Last name | Jinnai |
Organization
Ibaraki Prefectural University of Health Sciences
Division name
Graduate School of Health Sciences Master's Program
Zip code
300-0394
Address
4669-2 Ami, Ami-machi, Inashiki-gun, Ibaraki, Japan
TEL
0298884000
Homepage URL
44260123@ipu.ac.jp
Sponsor or person
Institute
Ibaraki Prefectural University of Health Sciences
Institute
Department
Personal name
Sumire Ishiyama
Funding Source
Organization
Ibaraki Prefectural University of Health Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tsukuba University of Technology,Center for Integrative Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ibaraki Prefectural University of Health Sciences Research Ethics Committee
Address
4669-2 Ami, Ami-machi, Inashiki-gun, Ibaraki, Japan
Tel
0298884000
kyoumu@ipu.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
茨城県立医療大学付属病院
筑波技術大学保健科学部附属東西医学統合医療センター
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 06 | 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
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
Preinitiation
Date of protocol fixation
| 2026 | Year | 06 | Month | 22 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 06 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is an observational study involving 50 patients with Parkinson's disease aged 60 years or older and 50 older adults aged 60 years or older.
Study procedures:
After written informed consent is obtained, grip strength will be measured using a grip strength meter. Participants will then be seated and fitted with a non-invasive neck-worn device, followed by a 5-minute resting period in the seated position. During the measurements, neck-only video recording will be performed to confirm swallowing timing.
For the repetitive saliva swallowing test (RSST), participants will be informed before the test that they will be asked after the test how many times they think they swallowed during the 30-second period. They will then be instructed to swallow saliva as many times as possible for 30 seconds, and the RSST will be performed. After the RSST, the number of swallows perceived by the participant will be recorded as the participant-reported swallowing count. The objectively measured swallowing count will be calculated primarily based on swallowing sounds recorded by the neck-worn device, and neck-only video recordings will be used to confirm whether swallowing occurred and to verify swallowing timing.
Subsequently, the 100 mL water swallowing test will be performed. Participants will be instructed to drink 100 mL of room-temperature water as quickly as possible, and the time required to consume the water will be measured. If choking, coughing, wet vocal quality, or related symptoms occur during the measurement, their presence or absence will be recorded.
Management information
Registered date
| 2026 | Year | 07 | Month | 01 | Day |
Last modified on
| 2026 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071063
