UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020673 |
|---|---|
| Receipt number | R000023856 |
| Scientific Title | The study on the effect of neurorehabilitation combined transcranial direct current stimulation with occupational therapy -focusing on unilateral spatial neglect- |
| Date of disclosure of the study information | 2016/05/01 |
| Last modified on | 2016/03/03 00:24:17 |
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Basic information
Public title
The study on the effect of neurorehabilitation combined transcranial direct current stimulation with occupational therapy -focusing on unilateral spatial neglect-
Acronym
The study on the effect of neurorehabilitation combined transcranial direct current stimulation with occupational therapy -focusing on unilateral spatial neglect-
Scientific Title
The study on the effect of neurorehabilitation combined transcranial direct current stimulation with occupational therapy -focusing on unilateral spatial neglect-
Scientific Title:Acronym
The study on the effect of neurorehabilitation combined transcranial direct current stimulation with occupational therapy -focusing on unilateral spatial neglect-
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effect of neurorehabilitation for stroke patients with unilateral spatial neglect
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Behavioural Inattention Test
The balloons test
Mini-Mental State Examination
Frontal Assessment Battery
Trail Making Test
SF-8
Barthel Index
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Transcranial direct current stimulation+ standard occuoational therapy
(14days/4weeks)
Standard occuoational therapy
(14days/4weeks)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Stroke patients with unilateral spatial neglect following on right hemisphere damage
Within 90days after stroke onset
Key exclusion criteria
Left handed
Dementia
Severe visual impairment
Aphasia
Pacemaker
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiko Futaki |
Organization
Graduate School of Medicine, Kyoto University
Division name
Human Health Sciences
Zip code
Address
53 Syogoin Kawahara-cho, Sakyo-ku, Kyoto-shi
TEL
075-751-3965
futaki.toshiko.2c@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoko Yokoyama |
Organization
Graduate School of Medicine, Kyoto University
Division name
Human Health Sciences
Zip code
Address
53 Syogoin Kawahara-cho, Sakyo-ku, Kyoto-shi
TEL
075-751-3965
Homepage URL
yokoyama.yoko.68w@st.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Human Health Sciences, Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2016 | Year | 05 | 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
| 2016 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 21 | Day |
Last modified on
| 2016 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023856
| Research Plan | |
|---|---|
| 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 |
