UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063057 |
|---|---|
| Receipt number | R000072187 |
| Scientific Title | Japan Spinal Cord Injury Natural History and Rehabilitation Study |
| Date of disclosure of the study information | 2026/09/30 |
| Last modified on | 2026/09/26 06:57:17 |
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Basic information
Public title
Japan Spinal Cord Injury Natural History and Rehabilitation Study
Acronym
J-SCINHR Study
Scientific Title
Japan Spinal Cord Injury Natural History and Rehabilitation Study
Scientific Title:Acronym
J-SCINHR Study
Region
| Japan |
Condition
Condition
Chronic traumatic spinal cord injury
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate longitudinal changes in neurological and activities of daily living functions in patients with chronic traumatic spinal cord injury at least one year after injury, and to characterize the natural history of chronic spinal cord injury in Japan and its association with rehabilitation. The study also aims to assess the feasibility of multicenter data collection, standardized assessment, and data quality management, thereby providing a foundation for a future registry of chronic spinal cord injury and for natural history studies and clinical research.
Basic objectives2
Others
Basic objectives -Others
Evaluation of the natural history of chronic traumatic spinal cord injury and its association with rehabilitation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total Motor Score (TMS) based on the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) at each assessment time point and its longitudinal change. documents
Key secondary outcomes
- Upper Extremity Motor Score (UEMS) and Lower Extremity Motor Score (LEMS) based on ISNCSCI
- Light Touch (LT) Total Score and Pin Prick (PP) Total Score based on ISNCSCI
- American Spinal Injury Association Impairment Scale (AIS)
- Modified Frankel classification
- Spinal Cord Independence Measure III (SCIM III)
- Walking Index for Spinal Cord Injury II (WISCI II)
Values at each assessment time point and their longitudinal changes will be evaluated.
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 with traumatic spinal cord injury.
2. Patients who received medical care at a participating institution between January 2012 and March 2030 at least one year after spinal cord injury.
3. Patients aged 18 years or older.
4. Patients who have undergone at least two ISNCSCI assessments at least one year after injury, or who are scheduled to undergo such assessments during the study period.
Key exclusion criteria
1. Patients with non-traumatic spinal cord injury.
2. Patients with apparent cognitive impairment or impaired consciousness.
3. Patients with other conditions affecting limb paralysis or motor function, including severe contractures or limb amputation.
4. Patients whose ISNCSCI assessments are considered to have been inadequately performed.
Target sample size
800
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, Japan
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
Department of Orthopaedic Surgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
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)
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Keio University school of medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
med-rinri-jimu@adst.keio.ac.jp
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
慶應義塾大学病院（東京都）、久留米リハビリテーション病院（福岡県）、下関リハビリテーション病院（山口県）、国立障害者リハビリテーションセンター病院（埼玉県）、別府重度障害者センター（大分県）、愛仁会リハビリテーション病院（大阪府）、聖マリアヘルスケアセンター（福岡県）、中伊豆リハビリテーションセンター（静岡県）、神奈川県総合リハビリテーションセンター（神奈川県）、千葉県千葉リハビリテーションセンター（千葉県）、国立病院機構村山医療センター（東京都）、総合せき損センター（福岡県）、北海道せき損センター（北海道）、兵庫県立リハビリテーション中央病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 30 | 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 | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2027 | Year | 02 | 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 | 09 | Month | 26 | Day |
Last modified on
| 2026 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072187
