UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046184 |
|---|---|
| Receipt number | R000052700 |
| Scientific Title | A novel screening method for patients with mild cervical myelopathy using a stabilometry |
| Date of disclosure of the study information | 2022/03/01 |
| Last modified on | 2024/05/30 23:09:32 |
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Basic information
Public title
A novel screening method for patients with mild cervical myelopathy using a stabilometry
Acronym
A novel screening method for patients with mild cervical myelopathy using a stabilometry
Scientific Title
A novel screening method for patients with mild cervical myelopathy using a stabilometry
Scientific Title:Acronym
A novel screening method for patients with mild cervical myelopathy using a stabilometry
Region
| Japan |
Condition
Condition
mild cervical myelopathy
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Identify novel screening methods in patients with mild cervical myelopathy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Center of Gravity Sway Index
Key secondary outcomes
tendon reflexes of the lower limb
joint position sense in the big toe test
two-point discrimination
tandem Walking test
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Stabilometry
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
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with cervical myelopathy with a Japanese Japanese orthopedic association score (JOA score) of 16 points or higher who have given consent to participate in the study
Key exclusion criteria
Persons whose comprehension is significantly impaired due to cognitive decline caused by dementia, etc
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | seiji |
| Middle name | |
| Last name | ohtori |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Orthopaedic Surgery
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba City, Chiba Prefecture
TEL
043-222-7171
sohtori@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | takeo |
| Middle name | |
| Last name | furuya |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Orthopaedic Surgery
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba City, Chiba Prefecture
TEL
043-222-7171
Homepage URL
furuya-takeo@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Department of Orthopaedic Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan.
Address
1-8-1 Inohana, Chuo-ku, Chiba City, Chiba Prefecture
Tel
043-222-7171
furuya-takeo@chiba-u.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
| 2022 | Year | 03 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 11 | Month | 25 | Day |
Last modified on
| 2024 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052700
