UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061677 |
|---|---|
| Receipt number | R000070573 |
| Scientific Title | Multicenter Observational Study on Inter-Rater Agreement of ISNCSCI Motor Scores |
| Date of disclosure of the study information | 2026/05/25 |
| Last modified on | 2026/05/25 10:19:04 |
* 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
Multicenter Observational Study on Inter-Rater Agreement of ISNCSCI Motor Scores
Acronym
ISNCSCI Motor Score Inter-Rater Agreement Study
Scientific Title
Multicenter Observational Study on Inter-Rater Agreement of ISNCSCI Motor Scores
Scientific Title:Acronym
ISNCSCI Motor Score Inter-Rater Agreement Study
Region
| Japan |
Condition
Condition
Spinal Cord Injury
Classification by specialty
| Neurology | Orthopedics | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the inter-rater agreement of ISNCSCI motor score assessments performed by multiple evaluators in patients with spinal cord injury.
Basic objectives2
Others
Basic objectives -Others
The ISNCSCI motor score is widely used as a key neurological outcome measure in spinal cord injury; however, inter-rater variability may affect the reliability of assessments. This study aims to clarify inter-rater agreement in real-world clinical practice and provide fundamental data to support standardization and quality improvement of assessment methods in future clinical research.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Degree of inter-rater agreement and distribution of differences in the Total Motor Score of the ISNCSCI motor assessment.
Key secondary outcomes
* Distribution of inter-rater differences for each muscle
* Absolute difference from the median value for each muscle
* Absolute difference from the median value for the Total Motor Score
* Proportion of Total Motor Scores falling within a predefined range
* Complete agreement rate of motor scores for each muscle
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
[Evaluators]
1. Physicians, physical therapists, occupational therapists, or nurses who routinely perform ISNCSCI assessments in clinical practice
2. Individuals who have provided consent to participate in this study
[Cooperative Patients]
1. Patients diagnosed with spinal cord injury
2. Patients who are able to undergo ISNCSCI assessment
3. Patients who have provided consent to participate in this study
Key exclusion criteria
[Evaluators]
1. Individuals who do not routinely perform ISNCSCI assessments in clinical practice
[Cooperative Patients]
1. Patients judged to have difficulty undergoing assessment due to severe pain, poor general condition, or other reasons
2. Patients judged by the principal investigator or investigators to be unsuitable for participation in this study
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | Narihito |
| Middle name | |
| Last name | Nagoshi |
Organization
Keio University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
keio.spinalregen@gmail.com
Public contact
Name of contact person
| 1st name | Spinal Cord Regeneration Research Office |
| Middle name | |
| Last name | Keio University School of Medicine |
Organization
Keio University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
keio.spinalregen@gmail.com
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Rakusera Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Commiittee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-3353-1211
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
| 2026 | Year | 05 | Month | 25 | 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 | 05 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | 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
| 2026 | Year | 05 | Month | 25 | Day |
Last modified on
| 2026 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070573
