UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041184 |
|---|---|
| Receipt number | R000047025 |
| Scientific Title | A study on the clinical effect of intensive intensive therapy and recurrent transcranial magnetic stimulation for upper limb dysfunction in patients with chronic stroke hemiplegia |
| Date of disclosure of the study information | 2020/07/21 |
| Last modified on | 2020/07/21 20:28:42 |
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Basic information
Public title
A study on the clinical effect of intensive intensive therapy and recurrent transcranial magnetic stimulation for upper limb dysfunction in patients with chronic stroke hemiplegia
Acronym
A study on the clinical effect of intensive intensive therapy and recurrent transcranial magnetic stimulation for upper limb dysfunction in patients with chronic stroke hemiplegia
Scientific Title
A study on the clinical effect of intensive intensive therapy and recurrent transcranial magnetic stimulation for upper limb dysfunction in patients with chronic stroke hemiplegia
Scientific Title:Acronym
A study on the clinical effect of intensive intensive therapy and recurrent transcranial magnetic stimulation for upper limb dysfunction in patients with chronic stroke hemiplegia
Region
| Japan |
Condition
Condition
Stroke hemiplegia
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Although the safety and usefulness of repetitive transcranial magnetic stimulation (rTMS) for stroke hemiplegia have been established, the clinical effects of combination therapy have not been sufficiently investigated. In this study, 40 patients with chronic hemiplegia including the elderly were treated with 90% stimulation of rTMS threshold and 10% with the purpose of clarifying the synergistic effect, the duration of the effect, and the usefulness in the elderly. Randomly assign to stimulation groups, perform intensive intensification therapy and prescribed rTMS to verify clinical effect.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fugl-Meyer assessment
Wolf Motor Function Test
Motor Activity Log
FIM,BI
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The subject is admitted to the hospital, and 90% of the rTMS motor threshold is stimulated in the healthy motor area using the Magstim Super Rapid with 1,200 1Hz rTMS at a given stimulus intensity. Immediately perform intensive reinforcement training (20 minutes for robot-assisted training for upper limbs using MA2, 40 minutes for goal-oriented repetitive training by an occupational therapist, and 60 minutes for self-training instructed by OT). During the other hours, 60 minutes of voluntary physical therapy (walking training to suspend the trunk by using a suspended walker to prevent falls and continuous extension of the ankles) is performed. These interventions will be conducted for 10 days on weekdays, and will be instructed to perform only voluntary training on weekends and festivals.
Interventions/Control_2
The subject is admitted to the hospital, and 10% rTMS motor threshold stimulation is applied to the motor area on the unaffected side using Magstim Super Rapid with 1,200 1Hz rTMS at a predetermined stimulation intensity. Immediately perform intensive reinforcement training (20 minutes for robot-assisted training for upper limbs using MA2, 40 minutes for goal-oriented repetitive training by an occupational therapist, and 60 minutes for self-training instructed by OT). During the other hours, 60 minutes of voluntary physical therapy (walking training to suspend the trunk by using a suspended walker to prevent falls and continuous extension of the ankles) is performed. These interventions will be conducted for 10 days on weekdays, and will be instructed to perform only voluntary training on weekends and festivals.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with chronic stroke hemiplegia who have mild to moderate paralysis in the upper limbs, who wish to improve upper limb paralysis, have no history of epileptic seizures, and have no epileptic discharge on EEG.
Key exclusion criteria
Patients with contraindication of rTMS
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yousuke |
| Middle name | |
| Last name | Nagano |
Organization
Kyushu Rosai Hospital Moji Medical Center
Division name
Central rehabilitation department
Zip code
801-0853
Address
3-1 Higashiminato-cho, Moji-ku, Kitakyushu City, Fukuoka Prefecture
TEL
09074442673
terasama74@gmail.com
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Matsumura |
Organization
Kyushu Rosai Hospital Moji Medical Center
Division name
Central rehabilitation department
Zip code
801-0853
Address
3-1 Higashiminato-cho, Moji-ku, Kitakyushu City, Fukuoka Prefecture
TEL
093-331-3461
Homepage URL
terasama74@gmail.com
Sponsor or person
Institute
Incorporated Administrative Agency Workers Health and Safety Organization Kyushu Rosai Hospital Moji Medical Center
Institute
Department
Personal name
Funding Source
Organization
Incorporated Administrative Agency Workers Health and Safety Organization Kyushu Rosai Hospital Moji Medical Center
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
Incorporated Administrative Agency Workers Health and Safety Organization Kyushu Rosai Hospital Moji Medical Center
Address
3-1 Higashiminato-cho, Moji-ku, Kitakyushu City, Fukuoka Prefecture
Tel
093-331-3461
terasama74@gmail.com
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
| 2020 | Year | 07 | Month | 21 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 04 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 07 | Month | 21 | Day |
Last modified on
| 2020 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047025
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