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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033324
Receipt No. R000037987
Scientific Title The effects of gait training during transcranial direct current stimulation on ankle dorsiflexion in patinets with stroke
Date of disclosure of the study information 2018/07/08
Last modified on 2020/07/09

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Basic information
Public title The effects of gait training during transcranial direct current stimulation on ankle dorsiflexion in patinets with stroke
Acronym The effects of gait training during transcranial direct current stimulation on ankle dorsiflexion in patinets with stroke
Scientific Title The effects of gait training during transcranial direct current stimulation on ankle dorsiflexion in patinets with stroke
Scientific Title:Acronym The effects of gait training during transcranial direct current stimulation on ankle dorsiflexion in patinets with stroke
Region
Japan

Condition
Condition stroke
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether or not gait training during transcranial direct current stimulation would improve ankle dorsiflexion of patients with post-stroke
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes walking during ankle dorsiflexion angle
walking during hip extension ankle
Key secondary outcomes 10-meter walking test
walking during body sway

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 gait training during transcranial direct current stimulation
Interventions/Control_2 gait training during functional electrical stimulation
Interventions/Control_3 usual rehabilitation program alone
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 1) Consent to participate in the study
2) The ability to walk without support for at least 16-meters
3) The score of SIAS foot-pat test is 1 or more.
4) Capability of communicating and understanding instructions
Key exclusion criteria 1) Contraindications for electrical stimulation
2) Severe sensory deficits
3) Neurological condition unrelated to stroke hemiparesis
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Tsubasa
Middle name
Last name Mitsutake
Organization Shiroishi Kyoritsu Hospital
Division name Department of Rehabilitation
Zip code 849-1112
Address 1296 Fukuta, Shiroishi-cho, Kishima-gun, Saga
TEL +81952846060
Email mitutuba1012@gmail.com

Public contact
Name of contact person
1st name Tsubasa
Middle name
Last name Mitsutake
Organization Shiroishi Kyoritsu Hospital
Division name Department of Rehabilitation
Zip code 849-1112
Address 1296 Fukuta
TEL 0952-84-6060
Homepage URL
Email mitutuba1012@gmail.com

Sponsor
Institute Shiroishi Kyoritsu Hospital
Institute
Department

Funding Source
Organization nothing
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 Shiroishi Kyoritsu Hospital
Address 1296 Fukuta, Shiroishi-cho, Kishima-gun, Saga
Tel +81952846060
Email mitutuba1012@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
2018 Year 07 Month 08 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 No longer recruiting
Date of protocol fixation
2018 Year 07 Month 08 Day
Date of IRB
2018 Year 04 Month 03 Day
Anticipated trial start date
2018 Year 07 Month 10 Day
Last follow-up date
2019 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 07 Month 08 Day
Last modified on
2020 Year 07 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037987

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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