UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058731 |
|---|---|
| Receipt number | R000067157 |
| Scientific Title | A Multi-phase Study of Non-insured Rehabilitation Service Users: Baseline Characteristics, Longitudinal Changes, and Intervention Effects |
| Date of disclosure of the study information | 2025/08/08 |
| Last modified on | 2025/08/08 07:26:20 |
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Basic information
Public title
A Multi-phase Study of Non-insured Rehabilitation Service Users: Baseline Characteristics, Longitudinal Changes, and Intervention Effects
Acronym
A Multi-phase Study of Non-insured Rehabilitation Service Users: Baseline Characteristics, Longitudinal Changes, and Intervention Effects
Scientific Title
A Multi-phase Study of Non-insured Rehabilitation Service Users: Baseline Characteristics, Longitudinal Changes, and Intervention Effects
Scientific Title:Acronym
A Multi-phase Study of Non-insured Rehabilitation Service Users: Baseline Characteristics, Longitudinal Changes, and Intervention Effects
Region
| Japan |
Condition
Condition
Patients with pain (acute pain, chronic pain)
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To cross-sectionally analyze baseline characteristics of users of non-insured rehabilitation services, longitudinally track their changes, and implement an intervention based on identified characteristics.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Demographics, Hospitalization history, Rehabilitation history, Past medical history, employment status, sports participation, pain-related factors, psychosocial variables, work productivity, pain severity and sites, exercise habits, sleep-related outcomes, and activities of daily living (ADL)-related questionnaire, Lifestyle factors.
Key secondary outcomes
Fall and injury history,Social background (family structure, care needs),Patient-reported outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver | Other |
Interventions/Control_1
Educational, Counseling, Training
Interventions/Control_2
usual care
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
| 12 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Individuals who have provided written informed consent for study participation
Patients with acute or chronic pain
Individuals who are independent or require only minimal assistance in activities of daily living (ADL)
Individuals deemed capable of participating in the study intervention (exercise, education, etc.)
Key exclusion criteria
Individuals with severe cognitive impairment or dementia that precludes effective communication
Individuals with severe cardiovascular, respiratory, or other serious comorbidities
Individuals for whom safe participation in the intervention is deemed difficult due to acute illness or injury
Pregnant or breastfeeding women
Any other individuals judged as inappropriate for study participation by the principal investigator
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | RYOTA |
| Middle name | |
| Last name | IMAI |
Organization
Osaka kawasaki Rehabilitation University
Division name
Department of Rehabilitation
Zip code
597-0104
Address
158, Mizuma, Kaizuka City, Osaka 597-0104, Japan.
TEL
+81-72-446-6700
ryo7891@gmail.com
Public contact
Name of contact person
| 1st name | RYOTA |
| Middle name | |
| Last name | IMAI |
Organization
Osaka kawasaki Rehabilitation University
Division name
Department of Rehabilitation
Zip code
597-0104
Address
158, Mizuma, Kaizuka City, Osaka 597-0104, Japan.
TEL
+81-72-446-6700
Homepage URL
ryo7891@gmail.com
Sponsor or person
Institute
Osaka kawasaki Rehabilitation University
Institute
Department
Personal name
Funding Source
Organization
No
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Kawasaki Rehabilitation University,
Address
158 Mizuma, Kaizuka City, Osaka 597-0104, Japan.
Tel
072-446-6700
ryo7891@gmail.com
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 | 08 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2028 | 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 | 08 | Month | 08 | Day |
Last modified on
| 2025 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067157
