UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043012 |
|---|---|
| Receipt number | R000049100 |
| Scientific Title | Sequential changes of spasticity in patients with chronic severe traumatic brain injury |
| Date of disclosure of the study information | 2021/01/15 |
| Last modified on | 2021/01/15 14:03:24 |
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Basic information
Public title
Sequential changes of spasticity in patients with chronic severe traumatic brain injury
Acronym
Sequential changes of spasticity for chronic sTBI
Scientific Title
Sequential changes of spasticity in patients with chronic severe traumatic brain injury
Scientific Title:Acronym
Sequential changes of spasticity for chronic sTBI
Region
| Japan |
Condition
Condition
Chronic severe traumatic brain injury
Classification by specialty
| Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the clinical factors that related to the sequential changes of spasticity in patients with chronic severe traumatic brain injury
Basic objectives2
Others
Basic objectives -Others
Finding clinical factors associated with spasticity in patients with chronic severe traumatic brain injury, we aim to provide early intervention to improve spasticity.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Modified Ashworth Scale (MAS)
Key secondary outcomes
Coma recovery scale-revised (CRS-R)
Range of motion (ROM)
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
1.Subjects with Glasgow Coma Scale <= 8 at the time of their accident and more than three months post injury
2.Subject who are hospitalized in our center
3.Subjects without limb deficiency
4.Subjects who can continue the rehabilitation
Key exclusion criteria
1.Subjects who cannot cooperate to the examination because of psychiatric instability
2.Subjects who cannot provide informed consent and adhere to the protocol
3.Subjects with a past history of orthopedic surgery for region of interest
4.Subjects who had a past history of spasticity before the accident
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Yamaki |
Organization
Rehabilitation Center for Traumatic Apallics Chiba
Division name
Neurosurgery
Zip code
261-0012
Address
3-30-1 Isobe, Mihama-ku, Chiba-shi, Chiba, Japan
TEL
043-277-0061
t-yamaki@chiba-ryougo.jp
Public contact
Name of contact person
| 1st name | Ryoichi |
| Middle name | |
| Last name | Ishizuka |
Organization
Rehabilitation Center for Traumatic Apallics Chiba
Division name
Rehabilitation division
Zip code
261-0012
Address
3-30-1 Isobe, Mihama-ku, Chiba-shi, Chiba, Japan
TEL
043-277-0061
Homepage URL
r-ishizuka@chiba-ryougo.jp
Sponsor or person
Institute
Rehabilitation Center for Traumatic Apallics Chiba
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Rehabilitation Center for Traumatic Apallics Chiba
Address
3-30-1 Isobe, Mihama-ku, Chiba-shi, Chiba, Japan
Tel
043-277-0061
takahito-seki@chiba-ryougo.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
| 2021 | Year | 01 | Month | 15 | 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
| 2020 | Year | 11 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2021 | Year | 01 | Month | 15 | Day |
Last modified on
| 2021 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049100
