UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032101 |
|---|---|
| Receipt number | R000036625 |
| Scientific Title | Repetitive peripheral magnetic stimulation for ambulation after stroke |
| Date of disclosure of the study information | 2018/04/12 |
| Last modified on | 2019/02/16 22:11:42 |
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Basic information
Public title
Repetitive peripheral magnetic stimulation for ambulation after stroke
Acronym
rPMS for ambulation afte stroke
Scientific Title
Repetitive peripheral magnetic stimulation for ambulation after stroke
Scientific Title:Acronym
rPMS for ambulation afte stroke
Region
| Japan |
Condition
Condition
stroke (cerebrovascular disease)
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the efficacy of rPMS for ambulation after stroke.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
10-meter walk test before and after the treatment.
Key secondary outcomes
Functional ambulation category(FAC), 6-minute walk test, timed up and go (TUG) test, range of Motion (ROM), modified Ashworth scale and 30-second Chair stand test.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Repetitive peripheral magnetic stimulation wi be administrated using parabolic coil (MMC 140). The intensity of stimulation will be set as 10% above the level that evoked a leg movement. The frequency will be 20 to 25 Hz. The duration of stimulation will be 1 to 3 second after rest time. 10 to 20 times of stimulation will be administrated for 14 to 21 days.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Stroke patients with hemiparesis
2) Functional Ambulation Category (FAC) 1 - 4
3) Patients who do not have cognitive impairment and be able to understand the study protocol.
Key exclusion criteria
1) Metal implants in the head or within the stimulation area
2) Medical implanted devices (cardiac pacemaker, etc)
3) Pregnancy
4) History of recent epilepsy
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shoji Kinoshita |
Organization
Aomori Shintoshi Hospital
Division name
Department of rehabilitation medicine
Zip code
Address
105-18, Ishie-takama, Aomori, Aomori
TEL
017-757-8750
s-kinoshita@yushinkai.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shoji Kinoshita |
Organization
Aomori Shintoshi Hospital
Division name
Department of rehabilitation medicine
Zip code
Address
105-18, Ishie-takama, Aomori, Aomori
TEL
017-757-8750
Homepage URL
s-kinoshita@yushinkai.jp
Sponsor or person
Institute
Aomori Shintoshi Hospital
Institute
Department
Personal name
Funding Source
Organization
Aomori Shintoshi Hospital
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
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
| 2018 | Year | 04 | Month | 12 | 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
Completed
Date of protocol fixation
| 2018 | Year | 04 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 04 | Day |
Last modified on
| 2019 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036625
