UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061503 |
|---|---|
| Receipt number | R000070374 |
| Scientific Title | Development of a prognostic model for functional recovery after spinal cord injury based on MRI findings and clinical assessments, with consideration of psychological and pain-related factors |
| Date of disclosure of the study information | 2026/05/09 |
| Last modified on | 2026/05/09 11:25:05 |
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Basic information
Public title
A study to predict recovery after spinal cord injury using MRI, physical function, and psychological assessments
Acronym
SCI Prognostic MRI Study
Scientific Title
Development of a prognostic model for functional recovery after spinal cord injury based on MRI findings and clinical assessments, with consideration of psychological and pain-related factors
Scientific Title:Acronym
A study on a prognostic model for outcomes in individuals with spinal cord injury
Region
| Japan |
Condition
Condition
Spinal Cord Injury
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development of a high-accuracy prognostic prediction model for Spinal Cord Injury based on MRI findings
Basic objectives2
Others
Basic objectives -Others
To explore the association between MRI findings and functional recovery, walking ability, after spinal cord injury.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
International Standards for Neurological Classification of SCI (The initial assessment was conducted at admission to the rehabilitation ward, and follow-up assessments were performed at 1-month intervals from the time of onset until discharge.)
Key secondary outcomes
[MRI Findings]
MRI images acquired immediately after injury will be used for analysis.
[Physical Function Assessment: Assessment timing is the same as the primary outcomes]
Spinal Cord Independence Measure III (SCIM-III), Functional Independence Measure (FIM), modified Frankel classification, tendon reflexes (patellar tendon, Achilles tendon, Hoffmann, Babinski), clonus (ankle and knee joints), Modified Ashworth Scale (hip flexion/extension/abduction/adduction, knee flexion/extension, ankle dorsiflexion/plantarflexion), 10-meter walking test (10MWT), Timed Up and Go test (TUG), Douleur Neuropathique 4 (DN4), PainDETECT, Neuropathic Pain Symptom Inventory (NPSI), Quantitative Sensory Testing (QST), Hospital Anxiety and Depression Scale (HADS), and Pain Catastrophizing Scale (PCS).
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
Patients with first-ever spinal cord injury who were admitted to a convalescent rehabilitation ward will be included.
Key exclusion criteria
1.Patients for whom informed consent could not be obtained
2.Patients with cognitive impairment (including dementia) that interferes with assessment
3.Patients with concomitant traumatic brain injury
4.Patients with a history of neurological disorders affecting motor or sensory function
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | akari |
| Middle name | |
| Last name | eda |
Organization
Japan Community Health care Organization Hoshigaoka Medical Center
Division name
Rehabilitation department
Zip code
573-8511
Address
4-8-1 Hoshigaoka, Hirakata, Osaka 573-8511 Japan
TEL
072-840-2641
ed.akr89@gmail.com
Public contact
Name of contact person
| 1st name | akari |
| Middle name | |
| Last name | eda |
Organization
Japan Community Health care Organization Hoshigaoka Medical Center
Division name
Rehabilitation department
Zip code
573-8851
Address
4-8-1 Hoshigaoka, Hirakata, Osaka 573-8511 Japan
TEL
072-840-2641
Homepage URL
ed.akr89@gmail.com
Sponsor or person
Institute
Japan Community Health care Organization Hoshigaoka Medical Center, rehabilitation, Akari Eda
Institute
Department
Personal name
Akari Eda
Funding Source
Organization
Kio university
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
Kio university
Address
4-2-2, Kouryotyou, Kitakaturagigun, Nara 635-0832, Japan
Tel
0745-54-1601
ed.akr89@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
星ヶ丘医療センター、千葉県千葉リハビリテーションセンター、西大和リハビリテーション病院、大阪急性期総合医療センター・岸和田リハビリテーション病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 09 | 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 | 09 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is an observational study with no specific intervention. Rehabilitation programs are individually tailored based on each patient's functional status and conducted as part of standard clinical care, and therefore variability in treatment content may influence the results. This is a multicenter collaborative study, and variability in assessment methods and rehabilitation practices across institutions may affect the findings. Assessments will be conducted according to a standardized protocol as much as possible. Furthermore, as this study includes exploratory analyses, further validation is required.
Management information
Registered date
| 2026 | Year | 05 | Month | 09 | Day |
Last modified on
| 2026 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070374
