UMIN-CTR Clinical Trial

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	Terminated
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	2022 Year 02 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037987