UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024655 |
|---|---|
| Receipt number | R000028356 |
| Scientific Title | Managements of neuro-rehabilitation for patients with acute stroke |
| Date of disclosure of the study information | 2016/11/01 |
| Last modified on | 2025/05/08 09:27:04 |
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Basic information
Public title
Managements of neuro-rehabilitation for patients with acute stroke
Acronym
Neuro-rehabilitation for acute strokes
Scientific Title
Managements of neuro-rehabilitation for patients with acute stroke
Scientific Title:Acronym
Neuro-rehabilitation for acute strokes
Region
| Japan |
Condition
Condition
Acute stroke
Classification by specialty
| Neurology | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aimed to construct a stroke database and to compare the effectiveness of rehabilitation by the different approaches of training in patients with acute stroke.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Baseline (at the initiation of stroke rehabilitation), 10 days, 20days, 90days after stroke onset
1)Laboratory data
2)Functional outcome
NIHSS score
Short Physical Performance Battery
Fugl-Meyer Assessment
Action Research Arm test
Functional Ambulation Categories
10 M walking
6 minute walking distance
Grips power, Manual Muscle Test
Box block test
Subjective visual vertical
Scale for Contraversive Pushing
3)Activity of daily living
modified Rankin Scale
Functional Independence Measure
Physical activity
4)Cognitive function
Mini-Mental State Examination test
Coloured progressive matrices by JC Raven
Behavioural Inattention Test
Addenbrooke's Cognitive Examination, Japanese version of Montreal Cognitive Assessment
CAT, S-PA
Trail Making Test
Wechsler Memory Scale Revised
Goodglass severity score
Screening Test for Aphasia and Dysarthria
5)Examination for depression
Geriatric Depression Scale
Apathy scale
Patient Health Questionnaire-9
6)Patient Reported Outcome
International Physical Activity Questionnaire short version
SF-36v2
EQ-5D-5L
Questionnaire of patient conditions
7)Amount of rehabilitation
Period of rehabilitation
Time to first mobilization
8)Adverse events
Deterioration of neurological sign
Stroke recurrence
Onset of Cardiovascular disease
Fall
9)Analysis of motor function by the motion capture
10)Assessment of skin deformity of the upper limb by the distance sensor array
11)Assessment of body composition by InBody, Phase angle
12)Health literacy scale
Key secondary outcomes
Analysis of diffusion tensor imaging(baseline, 90days after stroke onset)
Analysis of Neurite orientation dispersion and density imaging(baseline, 3 months)
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
a)18 years or older
b) Functional Ambulation Categories (FAC) 0-5
c) Patients who can mobile out of bed within 1 week of stroke onset
Key exclusion criteria
Patients judged inadequate in enrolling by the charged doctor
Target sample size
7000
Research contact person
Name of lead principal investigator
| 1st name | Chiak |
| Middle name | |
| Last name | Yokotai |
Organization
National Cerebral and Cardiovascular Center
Division name
Stroke rehabilitation
Zip code
564-8565
Address
6-1, Kishibe-Shimmachi, Suita, Osaka, Japan
TEL
06-6170-1070
yokota.chiaki@ncvc.go.jp
Public contact
Name of contact person
| 1st name | Chiaki |
| Middle name | |
| Last name | Yokota |
Organization
National Cerebral and Cardiovascular Center
Division name
Stroke rehabilitation
Zip code
564-8565
Address
6-1, Kishibe-Shimmachi, Suita, Osaka, Japan
TEL
06-6170-1070
Homepage URL
yokota.chiaki@ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
National Cerebral and Cardiovascular Center
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cerebral and Cardiovascular Center
Address
6-1,Kishibe-Shimmachi,Suita,Osaka,Japan
Tel
06-6170-1070
rec-office-ac@ncvc.go.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
国立循環器病研究センター
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 12 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2029 | Year | 03 | Month | 31 | Day |
Other
Other related information
single center observatiobnal study
Management information
Registered date
| 2016 | Year | 10 | Month | 31 | Day |
Last modified on
| 2025 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028356
