UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029311 |
|---|---|
| Receipt number | R000033507 |
| Scientific Title | Acute stroke rehabilitation for patients with upper limb motor dysfunction |
| Date of disclosure of the study information | 2017/10/01 |
| Last modified on | 2020/02/03 16:29:29 |
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Basic information
Public title
Acute stroke rehabilitation for patients with upper limb motor dysfunction
Acronym
Stroke rehabilitation for upper limb motor dysfunction
Scientific Title
Acute stroke rehabilitation for patients with upper limb motor dysfunction
Scientific Title:Acronym
Stroke rehabilitation for upper limb motor dysfunction
Region
| Japan |
Condition
Condition
Acute stroke
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study is to clarify the determinants of functional recovery for patients with upper limb dysfunction with stroke rehabilitation using the visual feed back system.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Functional outcome and activity of daily living 3 month after the registration.
Key secondary outcomes
1.Cognitive function and depression scale at baseline and 3 month after the registration.
2.Total periods of intervention.
3.Motion analyses (motion capture, surface EMG)
4.Diffusion tensor imaging
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Rehabilitation with conventional therapies
Interventions/Control_2
Rehabilitation using visual feedback system
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
1. 18 years or older who had a informed consent.
2. Functional Ambulation Categories (FAC) 0-5
3. Patients who can sit on the chair.
Key exclusion criteria
1. consciousness disturbance.
2. Patients who cannot be undergone rehabilitation due to muscle skeletal deformity or other than stroke.
3. Liver failure, renal failure.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chiaki Yokota |
Organization
National Cerebral and Cardiovascular Center
Division name
Stroke rehabilitation
Zip code
Address
5-7-1, Fujishirodai, Suita, Osaka, Japan
TEL
06-6833-5012
cyokota@ncvc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chiaki Yokota |
Organization
National Cerebral and Cardiovascular Center
Division name
Stroke rehabilitation
Zip code
Address
5-7-1, Fujishirodai, Suita, Osaka, Japan
TEL
06-6833-5012
Homepage URL
cyokota@ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Department of Stroke rehabilitation
Institute
Department
Personal name
Funding Source
Organization
National Cerebral and Cardiovascular Center
Department of Stroke rehabilitation
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
Address
Tel
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
| 2017 | Year | 10 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 09 | Month | 27 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 27 | Day |
Last modified on
| 2020 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033507
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
