UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060196 |
|---|---|
| Receipt number | R000068853 |
| Scientific Title | External Validation of a Clinical Predictive Rule for Walking in Patients with Spinal Vertebral Fractures and Development of a Predictive Model |
| Date of disclosure of the study information | 2025/12/25 |
| Last modified on | 2025/12/24 22:33:10 |
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Basic information
Public title
External Validation of a Clinical Predictive Rule for Walking in Patients with Spinal Vertebral Fractures and Development of a Predictive Model
Acronym
External Validation of a Clinical Predictive Rule for Walking in Patients with Spinal Vertebral Fractures and Development of a Predictive Model
Scientific Title
External Validation of a Clinical Predictive Rule for Walking in Patients with Spinal Vertebral Fractures and Development of a Predictive Model
Scientific Title:Acronym
External Validation of a Clinical Predictive Rule for Walking in Patients with Spinal Vertebral Fractures and Development of a Predictive Model
Region
| Japan |
Condition
Condition
Patients with vertebral body fractures
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To conduct external validation of CPR in patients with vertebral body fractures and develop a prognostic prediction model
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain, cognitive function, walking speed, balance function
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with vertebral body fractures
Key exclusion criteria
ndividuals with severe gait impairment due to neurological or musculoskeletal disorders other than vertebral fractures
Individuals who were not independently ambulatory prior to onset
Individuals who developed delayed paralysis in the lower limbs following vertebral fractures
Individuals who did not provide consent for this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masanobu |
| Middle name | |
| Last name | Yokochi |
Organization
Takeda General Hospital
Division name
Department of Rehabilitation
Zip code
965-8585
Address
3-27 Yamagamachi, Aizuwakamatsu, Fukushima
TEL
0242275511
masanobu3250@gmail.com
Public contact
Name of contact person
| 1st name | Masanobu |
| Middle name | |
| Last name | Yokochi |
Organization
Takeda General Hospital
Division name
Department of Rehabilitation
Zip code
965-8585
Address
3-27 Yamagamachi, Aizuwakamatsu, Fukushima
TEL
0242275511
Homepage URL
masanobu3250@gmail.com
Sponsor or person
Institute
Takeda General Hospital
Institute
Department
Personal name
Funding Source
Organization
Takeda General Hospital
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
Takeda General Hospital
Address
3-27 Yamagamachi, Aizuwakamatsu, Fukushima
Tel
0242275511
masanobu3250@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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | 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
| 2025 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Investigate the following information from the electronic medical record and record it on the investigation form. (Used for external validation of CPR and development of prognostic prediction models)
Subject's basic attributes (age, gender, disease name, medical history, height, weight, BMI)
Fracture severity (semi-quantitative assessment scale) and fracture type (presence or absence of posterior wall injury or intravertebral cleft)
Days until pre-discharge assessment (from vertebral fracture onset date to final pre-discharge assessment date)
Measure the following items in bed within 5 days of admission. (Used for external validation of CPR and development of prognostic prediction models)
Numerical Rating Scale (NRS): Measure pain intensity at bed rest using the NRS.
Pain Catastrophizing Scale (PCS): Measure catastrophic thinking about pain using a questionnaire administered while the patient is in bed. Distribute the questionnaire to the subject, have them complete it, and then collect it.
Management information
Registered date
| 2025 | Year | 12 | Month | 24 | Day |
Last modified on
| 2025 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068853
