UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017375 |
|---|---|
| Receipt number | R000020124 |
| Scientific Title | Combination approach of transcranial direct current stimulation and functional electorical stimulation for motor training of paretic hand after stroke |
| Date of disclosure of the study information | 2015/04/30 |
| Last modified on | 2020/06/10 17:52:41 |
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Basic information
Public title
Combination approach of transcranial direct current stimulation and functional electorical stimulation for motor training of paretic hand after stroke
Acronym
Transcranial direct current stimulation for paretic hand after stroke
Scientific Title
Combination approach of transcranial direct current stimulation and functional electorical stimulation for motor training of paretic hand after stroke
Scientific Title:Acronym
Transcranial direct current stimulation for paretic hand after stroke
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to test the hypothesis that combination of both tDCS and FES would enhance the motor training effects in patients with chronic stroke.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The evaluation is conducted using Wolf Motor Function Test(WMFT). WMFT has 15 functional tasks progressing from simple movements in proximal joints to complex tasks in distal joints using only the affected limb.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
transcranial direct current stimulation(tDCS) and functional electrical stimulation(FES)
Interventions/Control_2
tDCS and FESsham
Interventions/Control_3
tDCSsham and FES
Interventions/Control_4
tDCSsham and FESsham
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Single unilateral ischemic stroke
6 months after stroke onset
Key exclusion criteria
pacemaker
metal implants in the brain
Target sample size
13
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoyuki Takeuchi |
Organization
Tohoku University Graduates School of Medicine
Division name
Physical Medicine and Rehabilitation
Zip code
Address
2-1 Seiryo-cho, Aoba-ku, Sendai, 980-8575, Japan
TEL
022-717-7338
naoyuki@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayuki Mori |
Organization
Tohoku University Graduates School of Medicine
Division name
Physical Medicine and Rehabilitation
Zip code
Address
2-1 Seiryo-cho, Aoba-ku, Sendai, 980-8575, Japan
TEL
022-717-7338
Homepage URL
t-mori@med.tohoku.ac.jp
Sponsor or person
Institute
Department of Physical Medicine and Rehabilitation, Tohoku University Graduates School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
| 2015 | Year | 04 | Month | 30 | 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
| 2013 | Year | 10 | Month | 17 | Day |
Date of IRB
| 2013 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 01 | Day |
Last modified on
| 2020 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020124
