UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063001 |
|---|---|
| Receipt number | R000072125 |
| Scientific Title | Feasibility of wearable device based assessment in Parkinsons disease with focus on non motor symptoms |
| Date of disclosure of the study information | 2026/10/10 |
| Last modified on | 2026/09/20 15:47:34 |
* 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
Feasibility of wearable device based assessment in Parkinsons disease with focus on non motor symptoms
Acronym
WEAR-PD study
Scientific Title
Feasibility of wearable device based assessment in Parkinsons disease with focus on non motor symptoms
Scientific Title:Acronym
WEAR-PD study
Region
| Japan |
Condition
Condition
Parkinson's Disease
Classification by specialty
| Neurology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the feasibility of collecting daily life data using a commercially available wearable device in outpatients with Parkinsons disease including wearing continuity missing data and wearing burden
Basic objectives2
Others
Basic objectives -Others
To examine the association between non motor symptom scale scores and objective indicators obtained from the wearable device including sleep heart rate and physical activity
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Wearing continuity over 2 weeks valid data acquisition rate missing data rate and wearing burden of a commercially available wearable device
Key secondary outcomes
Association between non motor symptom scale scores and objective indicators obtained from the wearable device including sleep heart rate and physical activity
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients diagnosed and treated as Parkinson's disease by the attending physician (neurologist) at the outpatient clinic
2) Patients whom the attending physician determines to be in adequate physical and mental condition to complete the questionnaire
Key exclusion criteria
1) Patients who have difficulty understanding the questionnaire items or providing accurate responses due to cognitive impairment or other reasons
2) Patients who have skin disease injury or other conditions on the wrist that make it difficult to wear the Fitbit Inspire 3
3) Patients who do not own a smartphone and are unable to use one even with support from family members
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Michiaki |
| Middle name | |
| Last name | Koga |
Organization
Yamaguchi University Graduate School of Medicine
Division name
School of Health Sciences
Zip code
7558505
Address
1-1-1 Minamikogushi, Ube, Yamaguchi
TEL
0836-22-2111
kogamrk@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Miyuki |
| Middle name | |
| Last name | Imazawa |
Organization
Shionoseki City University
Division name
Faculty of Nursing
Zip code
7518510
Address
2-1-1, Daigakucho, Shimonoseki-shi, Yamaguchi, Japan
TEL
083-242-2837
Homepage URL
imazawa-mi@shimonoseki-cu.ac.jp
Sponsor or person
Institute
Yamaguchi University
Institute
Department
Personal name
Funding Source
Organization
Yamaguchi University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Neuromuscular Center Yoshimizu Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board Administration General Affairs Office, Faculty of Medicine and Health Sciences Yamaguchi University
Address
1-1-1 Minami Kogushi Ube Yamaguchi
Tel
0836-22-2007
me202@yamaguchi-u.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
| 2026 | Year | 10 | Month | 10 | 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 | 09 | Month | 17 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 11 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2028 | Year | 03 | Month | 31 | Day |
Other
Other related information
This is a prospective observational feasibility study without intervention Participants will wear a commercially available wearable device Fitbit Inspire 3 for 2 weeks to collect daily life data including sleep heart rate and step count Part of the data extraction process will be outsourced to an external vendor The data to be obtained will be limited to sleep heart rate and step count needed for this study and private information such as email photos and location data will not be accessed Participants will receive a 2000 yen QUO card after completing the study procedures
Management information
Registered date
| 2026 | Year | 09 | Month | 20 | Day |
Last modified on
| 2026 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072125
