UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058243 |
|---|---|
| Receipt number | R000066496 |
| Scientific Title | Investigation of the usefulness of the Japanese version of the international clinical assessment of physical function and activity level in persons with spinal cord injury |
| Date of disclosure of the study information | 2025/06/20 |
| Last modified on | 2025/06/20 17:52:04 |
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Basic information
Public title
Investigation of the usefulness of the Japanese version of the international clinical assessment of physical function and activity level in persons with spinal cord injury
Acronym
Investigation of the usefulness of the Japanese version of the international clinical assessment of physical function and activity level in persons with spinal cord injury
Scientific Title
Investigation of the usefulness of the Japanese version of the international clinical assessment of physical function and activity level in persons with spinal cord injury
Scientific Title:Acronym
Investigation of the usefulness of the Japanese version of the international clinical assessment of physical function and activity level in persons 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
To translate the ISNCSCI and PASIPD into Japanese using a translation process that takes into account linguistic validity, and to investigate the reliability and validity of its assessment methods in people with spinal cord injury.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Japanese version of the ISNCSCI, Japanese version of the PASIPD
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Those who have injured their cervical, thoracic, or lumbar spinal cord
(2) Those who are at least 18 years of age at the time of consent
(3) Those who can give verbal consent to participate in this study.
Key exclusion criteria
(1) History/comorbidities
Complications of brain injury
Joint immobilization, significant pain, joint contracture greater than 50% of normal ROM, fracture, or burn that would affect the outcome of the ISNCSCI evaluation
Neurological deficits not attributable to spinal cord injury (e.g., peripheral nerve palsy, brain nerve disease, demyelinating neurological disease, etc.)
Significant muscle weakness present prior to injury
Uncontrolled or severe medical, neoplastic, psychiatric, infectious, or musculoskeletal disease that would interfere with the performance of the evaluation
Dementia or a high probability of cognitive decline
(2) Those deemed inappropriate by the Principal Investigator or Principal Investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masaya |
| Middle name | |
| Last name | Nakamura |
Organization
Keio University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, JAPAN
TEL
0353633812
masa@keio.jp
Public contact
Name of contact person
| 1st name | Tomonori |
| Middle name | |
| Last name | Sawada |
Organization
Keio University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, JAPAN
TEL
0353633812
Homepage URL
tomonori-sawada@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
The General Insurance Association of Japan
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
Institutional Review Board of Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, JAPAN
Tel
0353633503
med-rinri-jimu@adst.keio.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 | 06 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 01 | Month | 06 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 26 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will assess individuals with spinal cord injury using the Japanese versions of the ISNCSCI and PASIPD, which were developed by translating the original English versions through a linguistically validated translation process. To evaluate reliability, two independent raters will conduct the same assessment on the same day (or on different days), and the degree of agreement between their results will be compared. To assess validity, additional evaluations related to walking ability, physical activity levels, and activities of daily living (ADL) will be performed and used for analysis.
The following information will be collected:
1) Participant Characteristics
Age, sex, height, and weight
Information related to spinal cord injury (date of injury and surgery, cause of injury, time since injury, neurological level of injury)
Other medical history: past medical history, comorbidities
2) Physical Assessments
Japanese version of ISNCSCI (done twice)
Japanese version of PASIPD (done twice)
Assessments of walking ability, physical activity levels, and ADL
Management information
Registered date
| 2025 | Year | 06 | Month | 20 | Day |
Last modified on
| 2025 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066496
