UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025795 |
|---|---|
| Receipt number | R000029666 |
| Scientific Title | Effect of Repetitive facilitative exercise synchronized with transcranial magnetic stimulation on hemiplegia of upper limb in stroke patients |
| Date of disclosure of the study information | 2017/01/26 |
| Last modified on | 2017/01/22 22:21:02 |
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Basic information
Public title
Effect of Repetitive facilitative exercise synchronized with transcranial magnetic stimulation on hemiplegia of upper limb in stroke patients
Acronym
TMS synchronized with RFE
Scientific Title
Effect of Repetitive facilitative exercise synchronized with transcranial magnetic stimulation on hemiplegia of upper limb in stroke patients
Scientific Title:Acronym
TMS synchronized with RFE
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of the repetitive facilitative exercise synchronized with transcranial magnetic stimulation on hemiplegia of upper limb in stroke patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fugl-Meyer Assessment
Action Research Arm Test
Modified Ashworth Scale
Key secondary outcomes
Box and Block test
Nine hole peg test
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
| Maneuver |
Interventions/Control_1
Patients receive the repetitive facilitative exercise synchronized with transcranial magnetic stimulation is applied for 4 weeks.
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
Patients in Kirishima Rehabilitation Center of Kagoshima University Hospital,
mild-to-moderate motor upper-limb deficits (Brunnstrom proximal upper-limb is more than stage 2)
Key exclusion criteria
clinically unstable medical disorders,
pain and contracture of the upper limb,
severe aphasia that made it impossible to follow the verbal instructions of the therapist,
intracranial metallic implants,
seizures.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seiji Etoh |
Organization
Graduate School of Medical and Dental Sciences
Division name
Department of Rehabilitation and Physical Medicine
Zip code
Address
Takachiho 3930-7, Makizono-Cho, Kirishima-City, Kagoshima, Japan
TEL
0995-78-2538
etohs@m2.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seiji Etoh |
Organization
Graduate School of Medical and Dental Sciences
Division name
Department of Rehabilitation and Physical Medicine
Zip code
Address
Takachiho 3930-7, Makizono-Cho, Kirishima-City, Kagoshima, Japan
TEL
0995-78-2538
Homepage URL
etohs@m2.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medical and Dental Sciences
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
| 2017 | Year | 01 | Month | 26 | 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 | 02 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 26 | 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
| 2017 | Year | 01 | Month | 22 | Day |
Last modified on
| 2017 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029666
| 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 |
