UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057351 |
|---|---|
| Receipt number | R000061441 |
| Scientific Title | Safety and feasibility of the Non-Bed Mobilization for acute stroke patients |
| Date of disclosure of the study information | 2025/03/21 |
| Last modified on | 2025/03/21 08:09:12 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Safety and feasibility of the Non-Bed Mobilization for acute stroke patients
Acronym
Non-Bed trial
Scientific Title
Safety and feasibility of the Non-Bed Mobilization for acute stroke patients
Scientific Title:Acronym
Non-Bed trial
Region
| Japan |
Condition
Condition
cerebral hemorrhage cerebral infarction
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine safety and feasibility of the high-dose mobilization protocol for acute stroke patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Out-of-bed time within the first 7 Days of randomization in the daytime between 9 am and 5 pm, which includes the time of sitting edge of the bed and wheelchair sitting.
Key secondary outcomes
Out-of-bed time within the first 14 Days of randomization in the daytime between 9 am and 5 pm, which includes the time of sitting edge of the bed and wheelchair sitting.
Adverse event rate
NIHSS (National Institutes of Health Stroke Scale)
mRS (Modified Rankin Scale)
ADL (Activities of Daily Living)
QOL (Quality of Life)
Sitting balance level
Walking ability level
Medical device use
Physical restraint use
Administration of sedative drugs
Activity level
Timing of mobilization
Outcome (Discharge home, Transfer to rehabilitation facility, Death)
Length of hospital stay
Incidence rate of complications
At Follow-up (3 Months Later)
ADL
Sitting balance level
mRS
Walking ability level
QOL (Quality of Life)
Home living rate
Employment status
Implementation of rehabilitation in the recovery phase after discharge
For Outpatient Visits Only
NIHSS
TUG (Timed Up and Go Test)
Items Collected for Sub-analysis
Urinary creatinine and titin levels
Fatigue
Delirium
Hospitalization costs
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Sitting, standing and walking as much as possible during day time additional to usual care for 14 days after randomization
Interventions/Control_2
Usual care
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
First attack of cerebral hemorrhage and cerebral infarction
18 years and older
Admitting to the hospital within 24 hours of onset
Key exclusion criteria
Immediate surgery except of thrombectomy
Another serious medical illness
Pre-morbid levels of disability (mRs 3 or more)
Comorbid progressive neurological conditions
Documented palliative care
Patients expected to be discharged early
Patients who do not agree with the study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hajime |
| Middle name | |
| Last name | Katsukawa |
Organization
Japanese Society for Early Mobilization
Division name
Scientific research
Zip code
102-0073
Address
1-2-12-2F Kudan-kita, Chiyoda-ku,Tokyo 102-0073, Japan
TEL
0335565585
winegood21@gmail.com
Public contact
Name of contact person
| 1st name | Hajime |
| Middle name | |
| Last name | Katsukawa |
Organization
Japanese Society for Early Mobilization
Division name
Scientific research
Zip code
102-0073
Address
1-2-12-2F Kudan-kita, Chiyoda-ku,Tokyo 102-0073, Japan
TEL
0335565585
Homepage URL
winegood21@gmail.com
Sponsor or person
Institute
Japanese Society for Early Mobilization
Institute
Department
Personal name
Hajime Katsukawa
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kumagaya General Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japanese Society for Early Mobilization
Address
1-2-12-2F Kudan-kita, Chiyoda-ku,Tokyo 102-0073, Japan
Tel
03-3356-5585
winegood21@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
熊谷総合病院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 21 | 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
| 2025 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 21 | Day |
Last follow-up date
| 2028 | 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
| 2025 | Year | 03 | Month | 21 | Day |
Last modified on
| 2025 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061441
