UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061704 |
|---|---|
| Receipt number | R000070354 |
| Scientific Title | External Validation of Existing Clinical Prediction Models for Gait Prognosis in Individuals with Spinal Cord Injury and Development of a New Prediction Model |
| Date of disclosure of the study information | 2026/06/30 |
| Last modified on | 2026/06/22 17:16:30 |
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Basic information
Public title
External Validation of Existing Clinical Prediction Models for Gait Prognosis in Individuals with Spinal Cord Injury and Development of a New Prediction Model
Acronym
External Validation of Existing Clinical Prediction Models for Gait Prognosis in Individuals with Spinal Cord Injury and Development of a New Prediction Model
Scientific Title
External Validation of Existing Clinical Prediction Models for Gait Prognosis in Individuals with Spinal Cord Injury and Development of a New Prediction Model
Scientific Title:Acronym
External Validation of Existing Clinical Prediction Models for Gait Prognosis in Individuals with Spinal Cord Injury and Development of a New Prediction Model
Region
| Japan |
Condition
Condition
Spinal Cord Injury
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To externally validate existing clinical prediction models (CPM) for predicting gait prognosis in individuals with subacute spinal cord injury and to evaluate their predictive performance and clinical utility.
Basic objectives2
Others
Basic objectives -Others
To develop a novel CPM for walking independence in individuals with spinal cord injury during the recovery phase.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Spinal Cord Independence Measure III
Key secondary outcomes
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI), 10-Meter Walk Test (10MWT), 6-Minute Walk Test (6MWT), Timed Up and Go Test (TUG), Functional Ambulation Categories (FAC), Walking Index for Spinal Cord Injury II (WISCI-II), Spinal Cord Injury Functional Ambulation Inventory (SCI-FAI), Functional Independence Measure (FIM), Basic mobility tasks (rolling, supine-to-sit movement, sitting, sit-to-stand movement, and standing)
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Individuals with spinal cord injury (including traumatic and non-traumatic spinal cord injury) within 1-3 months after injury
Key exclusion criteria
Individuals who indicated their refusal to participate in this study through the opt-out process.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shinogu |
| Middle name | |
| Last name | Kusano |
Organization
Ibaraki Prefectural University of Health Sciences Hospital
Division name
Rehabilitation Department
Zip code
3000331
Address
4733 Ami, Ami Town, Inashiki District, Ibaraki Prefecture
TEL
0298889200
kusanos@ami.ipu.ac.jp
Public contact
Name of contact person
| 1st name | Shinogu |
| Middle name | |
| Last name | Kusano |
Organization
Ibaraki Prefectural University of Health Sciences Hospital
Division name
Rehabilitation Department
Zip code
3000331
Address
4733 Ami, Ami Town, Inashiki District, Ibaraki Prefecture
TEL
0298889200
Homepage URL
kusanos@ami.ipu.ac.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ibaraki Prefectural University of Health Sciences
Address
4669-2 Ami, Ami Town, Inashiki District, Ibaraki Prefecture
Tel
0298884000
iizima@ipu.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 | 06 | 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 | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(Inclusion criteria)
Individuals with spinal cord injury (traumatic or non-traumatic) who were admitted to the disability ward or convalescent rehabilitation ward of Ibaraki Prefectural University of Health Sciences Hospital and received rehabilitation between April 1, 2017 and April 30, 2026 will be included.
Participants admitted to our hospital within 1-3 months after the onset of spinal cord injury will be included.
(Exclusion criteria)
Individuals who opted out and expressed unwillingness to participate in this study will be excluded.
(Statistical analysis)
External validation of existing clinical prediction models (CPMs) for walking independence in individuals with spinal cord injury
The discrimination performance of existing CPMs will be evaluated using the Receiver Operating Characteristic (ROC) curve and the Area Under the Curve (AUC). Model calibration will be assessed using calibration plots. In addition, sensitivity, specificity, positive predictive value, and negative predictive value will be calculated.
Development of a novel clinical prediction model for walking independence in individuals with spinal cord injury
Logistic regression analysis will be performed with walking independence/dependence as the dependent variable. In addition, decision tree analysis will be conducted to explore the hierarchical structure of factors associated with walking prognosis. Model performance will be evaluated using the ROC curve and AUC.
Management information
Registered date
| 2026 | Year | 05 | Month | 27 | Day |
Last modified on
| 2026 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070354
