UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047489 |
|---|---|
| Receipt number | R000054156 |
| Scientific Title | A Multicenter Randomized Controlled Trial of the Intervention Effectiveness of NEURO in repetitive Trans cranial Magnetic Stimulation combined with Functional Exercises involved Occupational Therapy optimized by the Specifying Level of Difficulty, Amount of Practice, and Goal Setting Methods in Stroke patients with paralysis. |
| Date of disclosure of the study information | 2022/05/01 |
| Last modified on | 2023/10/15 14:57:28 |
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Basic information
Public title
A Multicenter Randomized Controlled Trial on the Effect of repetitive Transcranial Magnetic Stimulation combined with Occupational Therapy to optimization in the Specified Practice Difficulty, Amount of Practice, and Goalsetting methods in Stroke patients with paralysis.
Acronym
Trial on the Effect of rTMS combined with optimized methods of OT in Stroke patients with paralysis.
Scientific Title
A Multicenter Randomized Controlled Trial of the Intervention Effectiveness of NEURO in repetitive Trans cranial Magnetic Stimulation combined with Functional Exercises involved Occupational Therapy optimized by the Specifying Level of Difficulty, Amount of Practice, and Goal Setting Methods in Stroke patients with paralysis.
Scientific Title:Acronym
Trial of the NEURO in optimized Occupational Therapy for Stroke patients.
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the therapeutic effects of providing functional exercises with defined practice difficulty and practice volume to patients undergoing repetitive transcranial magnetic stimulation and intensive occupational therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fugl-Meyer Assessment of the Upper Extremity
Key secondary outcomes
Action Research Arm Test
Jikei Assessment Scale for Motor Impairment in Daily Living
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Intervention group: (1) functional exercises selected according to the specifics of motor paralysis (2) provided at a constant practice volume, and (3) post-treatment scores are calculated from prediction equations and shared with the patient.
Interventions/Control_2
Control group: Conventional occupational therapy is provided.
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
(1) Hemiplegia after stroke
(2) Age 20 years or older
(3) 6 months have passed since the onset of stroke
(4) No bilateral cerebrovascular disease
Key exclusion criteria
(1) Those with a diagnosis of dementia
(2) Those with physical or mental illness requiring medical management
(3) Those with the onset of seizures within one year
(4) Those with intracranial clips or cardiac pacemakers
(5) Pre-existing subarachnoid hemorrhage
Target sample size
124
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Abo |
Organization
The Jikei University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
1058471
Address
3-25-8 Nishi-Shinbashi, Minato-ku, Tokyo, Japan
TEL
03-3433-1111
abo@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Daigo |
| Middle name | |
| Last name | Sakamoto |
Organization
The Jikei University Graduate School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
1058471
Address
3-25-8 Nishi-Shinbashi, Minato-ku, Tokyo, Japan
TEL
03-3433-1111
Homepage URL
daigo.0612@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Subjects Committee of the Jikei University School of Medicine
Address
3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo, Japan
Tel
03-3433-1111
rinri@jikei.ac.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
東京慈恵会医科大学附属病院（東京） / The Jikei University Hospital (Tokyo, Japan)
東京慈恵会医科大学第三病院（東京） / The Jikei University Daisan Hospital (Tokyo, Japan)
函館新都市病院（北海道） / Hakodate Shintoshi Hospital (Hokkaido, Japan)
青森新都市病院（青森） / Aomori Shintoshi Hosppital (Aomori, Japan)
総合東京病院（東京） / General Tokyo Hospital (Tokyo, Japan)
いずみ記念病院（東京） / Izumi Memorial Hospital (Tokyo, Japan)
京都大原記念病院（京都） / Kyoto Ohara Memorial Hospital (Kyoto, Japan)
西広島リハビリテーション病院（広島） / Nishi-Hiroshima Rehabilitation Hospital(Hiroshima, Japan)
八反丸リハビリテーション病院（鹿児島） / Hattanmaru Rehabilitation Hospital（Kagoshima, Japan）
Other administrative information
Date of disclosure of the study information
| 2022 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is ongoing and data is being accumulated.
Management information
Registered date
| 2022 | Year | 04 | Month | 14 | Day |
Last modified on
| 2023 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054156
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| Registered date | File name |
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