UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017137 |
|---|---|
| Receipt number | R000019876 |
| Scientific Title | Study of combined effect of repetitive transcranial magnetic stimulation and intensive rehabilitation for post-stroke patients |
| Date of disclosure of the study information | 2015/04/20 |
| Last modified on | 2019/04/26 10:35:56 |
* 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
Study of combined effect of repetitive transcranial magnetic stimulation and intensive rehabilitation for post-stroke patients
Acronym
rTMS and intensive rehabilitation
Scientific Title
Study of combined effect of repetitive transcranial magnetic stimulation and intensive rehabilitation for post-stroke patients
Scientific Title:Acronym
rTMS and intensive rehabilitation
Region
| Japan |
Condition
Condition
Patients with upper limb paralysis or aphasia due to post-stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the combined effect of repetitive transcranial magnetic stimulation and intensive rehabilitation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Wolf Motor Function Test(WMFT), Motor Activity Log(MAL) etc. for upper limb paralysis
Standard Language Test of Aphasia (SLTA) for aphasia
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
repetitive transcranial magnetic stimulation: 1Hz,2400pulses/day,10days
intensive rehabilitation: 5hour/day,10days
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. upper limb paralysis or aphasia due to stroke
2. over 6 months after stroke
Key exclusion criteria
1. dementia
2. depression
3. dialysis
4. intracranial metal
5. history of seizures within a year
6. pregnancy
7. a serious medical condition
8. level of dependence in activities of daily living
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yasutaka |
| Middle name | |
| Last name | Kobayashi |
Organization
Fukui General Hospital
Division name
Department of Rehabilitation Medicine
Zip code
910-8561
Address
58-16-1, Egami-cho, Fukui-shi, Fukui, JAPAN
TEL
0776591300
yasutaka_k@mri.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | Yasutaka |
| Middle name | |
| Last name | Kobayashi |
Organization
Fukui General Hospital
Division name
Department of Rehabilitation Medicine
Zip code
910-8561
Address
58-16-1, Egami-cho, Fukui-shi, Fukui, JAPAN
TEL
0776591300
Homepage URL
yasutaka_k@mri.biglobe.ne.jp
Sponsor or person
Institute
Fukui General Hospital
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
Ethics Committee of Nittazuka Medical Welfare Center
Address
58-16-1, Egami-cho, Fukui-shi, Fukui, JAPAN
Tel
0776-59-1300
fgh-hisyo@mopera.net
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 | 20 | 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
| 2015 | Year | 04 | Month | 14 | Day |
Date of IRB
| 2015 | Year | 04 | Month | 09 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2019 | 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
| 2015 | Year | 04 | Month | 14 | Day |
Last modified on
| 2019 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019876
