UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of transcranial direct-current stimulation and body-weight-supported treadmill training on gait recovery in hemiparetic patients after stroke.
Title of the study (Brief title)	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	Manji Atsushi
Organization	Saitama misato sogo rehabilitaion hospital
Division name	Rehabilitaion div
Address	5-207 Shinwa, misato-city, Saitama-prefecture
TEL	048-953-1211
Email	magokuro19811129@yahoo.co.jp

Public contact
Name of contact person	Manji Atsushi
Organization	Saitama misato sogo rehabilitaion hospital
Division name	Rehabilitaion div
Address	5-207 Shinwa, misato-city, Saitama-prefecture
TEL	048-953-1211
Homepage URL
Email	magokuro19811129@yahoo.co.jp

Sponsor
Institute	Saitama misato sogo rehabilitaion hospital. Rehabilitaion div.
Institute
Department

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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2017 Year 01 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032047