UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025212 |
|---|---|
| Receipt number | R000029000 |
| Scientific Title | The effect of repetitive facilitative exercise synchronized with transcranial magnetic stimulation on hemiplegic upper limb |
| Date of disclosure of the study information | 2016/12/28 |
| Last modified on | 2021/06/14 13:41:36 |
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Basic information
Public title
The effect of repetitive facilitative exercise synchronized with transcranial magnetic stimulation on hemiplegic upper limb
Acronym
RFE synchronized with TMS
Scientific Title
The effect of repetitive facilitative exercise synchronized with transcranial magnetic stimulation on hemiplegic upper limb
Scientific Title:Acronym
RFE synchronized with TMS
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 repetitive facilitative exercise synchronized with transcranial magnetic stimulation on hemiplegic upper limb
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fugl-Meyer Assessment (upper limb)
Key secondary outcomes
Action Research Arm Test
Modified Ashworth Scale
resting motor threshold
amplitude of motor evoked potential
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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
repetitive facilitative exercise synchronized with transcranial magnetic stimulation
(50-200 stimulation/day, 5 days/week, 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
| 15 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) admitted patients in Kirishima Rehabilitation Center in Kagoshima University
2) more than Brunnstrom stage 2 in hemiplegic upper limb
Key exclusion criteria
1) clinically unstable medical disorders
2) pain and contracture of the upper limb
3) severe aphasia that made it impossible to follow the verbal instructions of the therapist
4) intracranial metallic implants
5) seizures
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Seiji |
| Middle name | |
| Last name | Etoh |
Organization
Guraduate School of Medical and Dental Sciences, Kagoshima University
Division name
Department of Rehabilitation and PhysicalMedicine
Zip code
890-8520
Address
Sakuragaoka 8-35-1, Kagoshima-City, Kagoshima, Japan
TEL
0992755339
etohs@m2.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Seiji |
| Middle name | |
| Last name | Etoh |
Organization
Guraduate School of Medical and Dental Sciences, Kagoshima University
Division name
Department of Rehabilitation and PhysicalMedicine
Zip code
890-8520
Address
Sakuragaoka 8-35-1, Kagoshima-City, Kagoshima, Japan
TEL
0992755339
Homepage URL
etohs@m2.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Department of Rehabilitation and PhysicalMedicine, Guraduate School of Medical and Dental Sciences, Kagoshima University
Institute
Department
Personal name
Funding Source
Organization
Department of Rehabilitation and PhysicalMedicine, Guraduate School of Medical and Dental Sciences, Kagoshima University
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
Department of Rehabilitation and PhysicalMedicine, Guraduate School of Medical and Dental Sciences, Kagoshima University
Address
Sakuragaoka 8-35-1, Kagoshima-City, Kagoshima, Japan
Tel
0992755339
etohs@m2.kufm.kagoshima-u.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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 28 | 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
| 2016 | Year | 12 | Month | 28 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 10 | Day |
Last modified on
| 2021 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029000
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
