UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057346 |
|---|---|
| Receipt number | R000065529 |
| Scientific Title | A multicenter, open-label, single-arm interventional clinical study on handwriting training focusing on pen pressure for patients with Parkinson's disease |
| Date of disclosure of the study information | 2025/03/20 |
| Last modified on | 2025/03/19 18:23:27 |
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Basic information
Public title
A multicenter, open-label, single-arm interventional clinical study on handwriting training focusing on pen pressure for patients with Parkinson's disease
Acronym
A multicenter, open-label, single-arm interventional clinical study on handwriting training focusing on pen pressure for patients with Parkinson's disease
Scientific Title
A multicenter, open-label, single-arm interventional clinical study on handwriting training focusing on pen pressure for patients with Parkinson's disease
Scientific Title:Acronym
A multicenter, open-label, single-arm interventional clinical study on handwriting training focusing on pen pressure for patients with Parkinson's disease
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether writing pressure-aware writing training for PD patients changes (improves) dysgraphia, PD symptoms, PD-related writing pressure and writing, and PD-related symptoms.
Basic objectives2
Others
Basic objectives -Others
Improvement of handwriting through pressure-conscious calligraphy training
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Investigation of improvement of handwriting through pressure-conscious writing training
Key secondary outcomes
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
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
1) Pre-test (30 minutes): Confirmation of writing style and measurement of various evaluation indices such as writing pressure
2) Writing training with an awareness of writing pressure (60 minutes): Writing training with an awareness of writing pressure
3) Post-training test (30 min): Confirmation of handwriting after training and measurement of various evaluation indices
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
| 55 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Age between 55 and 65 years old at the time of consent.
2) Patients who have been diagnosed with Parkinson's disease (clinically established or clinically almost certain) according to the 'MDS-PD Criteria (2015)' or who meet the diagnostic criteria for prodromal stage Parkinson's disease.
3) Gender: any gender
4) Inpatient/outpatient:No preference
5) Patients who have been fully informed about their participation in the study, and who have given their free and voluntary written consent based on their full understanding of the study.
6) Patients who are able to write.
Key exclusion criteria
1) Patients who are unable to follow the procedures of this study
2) Patients with writing difficulties
3) Patients with any of the following complications
Serious complications (cerebrovascular disease, cardiac disease, chronic respiratory disease, uncontrolled hypertension, diabetes mellitus, etc.)
4) Other patients deemed inappropriate as research subjects by the principal investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Wataru |
| Middle name | |
| Last name | Sako |
Organization
Juntendo University Hospital
Division name
Department of Neurology
Zip code
113-8431
Address
3-1-3 Hongo Bunkyo-ku, Tokyo
TEL
03-3813-3111
w.sako.fn@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Wataru |
| Middle name | |
| Last name | Sako |
Organization
Juntendo University Hospital
Division name
Department of Neurology
Zip code
113-8431
Address
3-1-3 Hongo Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
w.sako.fn@juntendo.ac.jp
Sponsor or person
Institute
other
Institute
Department
Personal name
Funding Source
Organization
self-procurement
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
Research Ethics Committee, Faculty of Medicine, Juntendo University
Address
3-1-3 Hongo,Bunkyo-ku,Tokyo
Tel
03-3813-3111
hongo-rinri@juntendo.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
| 2025 | Year | 03 | Month | 20 | 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
| 2024 | Year | 12 | Month | 09 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 03 | Month | 19 | Day |
Last modified on
| 2025 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065529
