UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058271 |
|---|---|
| Receipt number | R000066615 |
| Scientific Title | Anonymous Web-based Survey of Patient INvolvement and Engagement in Clinical Trials for Spinal Cord Injury |
| Date of disclosure of the study information | 2025/08/26 |
| Last modified on | 2025/08/26 10:22:30 |
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Basic information
Public title
Anonymous Web-based Survey on Willingness to Participate in Clinical Trials among Spinal Cord Injury Patients
Acronym
SPINE-VOICE
Scientific Title
Anonymous Web-based Survey of Patient INvolvement and Engagement in Clinical Trials for Spinal Cord Injury
Scientific Title:Acronym
SPINE-VOICE
Region
| Japan |
Condition
Condition
Spinal Cord Injury
Classification by specialty
| Orthopedics | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to investigate the willingness of individuals with spinal cord injury to participate in future clinical trials of spinal cord regenerative medicine. In particular, the survey aims to assess attitudes toward randomized controlled trials (RCTs), including the possibility of being assigned to a control group, and to identify factors influencing willingness, such as time since injury, severity, daily living situation, and expectations regarding treatment.
Basic objectives2
Others
Basic objectives -Others
To identify factors associated with the willingness of spinal cord injury patients to participate in clinical trials, including time since injury, injury severity, neurological level, mobility, caregiving situation, and rehabilitation frequency.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Willingness to participate in a randomized controlled trial, even when there is a possibility of being assigned to a control group without receiving regenerative therapy
Key secondary outcomes
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
Individuals aged 18 years or older with spinal cord injury
Or proxy respondents (e.g., family members) responding on behalf of the patient upon request
Key exclusion criteria
When the principal investigator or sub-investigator determines that participation in the study is inappropriate
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Masaya |
| Middle name | |
| Last name | Nakamura |
Organization
Keio University School of Medicine
Division name
Orthopaedics
Zip code
1608582
Address
35 Shinanomachi, Shinjuku, Tokyo
TEL
03-3353-1211
keio.spinalregen@gmail.com
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Sugai |
Organization
Keio University School of Medicine
Division name
Orthopaedics
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku, Tokyo
TEL
03-3353-1211
Homepage URL
keio.spinalregen@gmail.com
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS), Grants-in-Aid for Scientific Research (KAKENHI)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Secretariat, Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-5363-3611
med-rinri-jimu@adst.keio.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 | 08 | Month | 26 | 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
| 2025 | Year | 07 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | 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
None
Management information
Registered date
| 2025 | Year | 06 | Month | 25 | Day |
Last modified on
| 2025 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066615
