UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027980 |
|---|---|
| Receipt number | R000032047 |
| Scientific Title | Effects of transcranial direct-current stimulation and body-weight-supported treadmill training on gait recovery in hemiparetic patients after stroke. |
| Date of disclosure of the study information | 2017/06/28 |
| Last modified on | 2017/12/27 09:46:21 |
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Basic information
Public title
Effects of transcranial direct-current stimulation and body-weight-supported treadmill training on gait recovery in hemiparetic patients after stroke.
Acronym
tDCS and BWSTT combined therapy for stroke patients.
Scientific Title
Effects of transcranial direct-current stimulation and body-weight-supported treadmill training on gait recovery in hemiparetic patients after stroke.
Scientific Title:Acronym
tDCS and BWSTT combined therapy for stroke patients.
Region
| Japan |
Condition
Condition
heniparetic patients after stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of combined therapy with tDCS and BWSTT in hemiparetic patients after CVA on improvement in gait ability.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Gait velocity - 10m walk test
Applicative walk ability - Timed up and go test
Key secondary outcomes
Lower Extremity functions - Fugl-Meyer Assessment of the Lower Extremity
Balance ability - Performance Oriented Mobility Assessment
Trunk function - Trunk Impairment Scale
Activities of daily living - Functional Independence Measure.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved 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
Transcranial direct current stimulation, 1mA, 20min, anode:supplementary motor area, cathode:inion, 1/day, 5/week, 1week.
Body weight supported treadmill trainning, 20min, 1/day, 5/week, 1week.
Interventions/Control_2
Sham stimulation, 20min, anode:supplementary motor area, cathode:inion, 1/day, 5/week, 1week.
Body weight supported treadmill trainning, 20min, 1/day, 5/week, 1week.
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
| 30 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
New onset of a supratentorial lesion and a gait disorder, ability to walk 20 meters with observation or slight assistance, and ability to undergo BWSTT.
Key exclusion criteria
Orthopedic/systemic diseases that limit exercise therapy, severe dementia/higher brain dysfunction with difficulty understanding directions, implanted metal in the head or an implanted cardiac pacemaker, and difficulty undergoing BWSTT as judged by the physician in charge.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Manji Atsushi |
Organization
Saitama misato sogo rehabilitaion hospital
Division name
Rehabilitaion div
Zip code
Address
5-207 Shinwa, misato-city, Saitama-prefecture
TEL
048-953-1211
magokuro19811129@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Manji Atsushi |
Organization
Saitama misato sogo rehabilitaion hospital
Division name
Rehabilitaion div
Zip code
Address
5-207 Shinwa, misato-city, Saitama-prefecture
TEL
048-953-1211
Homepage URL
magokuro19811129@yahoo.co.jp
Sponsor or person
Institute
Saitama misato sogo rehabilitaion hospital.
Rehabilitaion div.
Institute
Department
Personal name
Funding Source
Organization
no
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 | 06 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2017 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 01 | 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 | 06 | Month | 28 | Day |
Last modified on
| 2017 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032047
| 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 |
