UMIN-CTR Clinical Trial

Basic information
Public title	Effect of stroke patients with hemiplegia with the gait rehabilitation training using the biofeedback device to share paralyzed-side foot contact of the patient on the waist and back
Acronym	Effect of stroke patients with hemiplegia with the gait rehabilitation training using the biofeedback device
Scientific Title	Effect of stroke patients with hemiplegia with the gait rehabilitation training using the biofeedback device to share paralyzed-side foot contact of the patient on the waist and back
Scientific Title:Acronym	Effect of stroke patients with hemiplegia with the gait rehabilitation training using the biofeedback device
Region	Japan

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

Objectives
Narrative objectives1	We test the effect of the biofeedback device on stroke patients with hemiplegia
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Gait speed(Immediately after intervention)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Usual gait rehabilitation training(Use Period:None)
Interventions/Control_2	Gait rehabilitation training patient's using the biofeedback device (Use Period: 1 day(15 min))
Interventions/Control_3	Gait rehabilitation training patient's and therapist's using the biofeedback device(Use Period: 1 day(15 min))
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	20 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	Patient who agree to the clinical test and meet the following conditions. 1. Patient's recovery stage is Brunnstrom stage 3/4/5 2. The patient has no higher brain dysfunction. 3. Primary doctor and therapist allowed patients to the gait training.
Key exclusion criteria	The patient has the following serious condition 1.Uncontrollable heart failure 2.Acute myocardial infarction 3.Myocarditis,pericarditis 4.Angina pectoris 5.Acute embolism, pulmonary embolism 6.Acute infection 7.Thrombophlebitis 8.Ventricular tachycardia, ventricular arrhythmia 9.Uncontrollable arterial hypertension, pulmonary hypertension
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Hiroyasu Middle name Last name Iwata
Organization	Waseda University
Division name	Faculty science and engineering
Zip code	162-0042
Address	27 Waseda-cyo, Shinjuku-ku, Tokyo 162-0044, Japan Green Computing Systems Reserch Organization 603 Prof. Iwata Lab.
TEL	03-3203-4427
Email	jubi@waseda.jp

Public contact
Name of contact person	1st name Hiroyasu Middle name Last name Iwata
Organization	Waseda University
Division name	Faculty science and engineering
Zip code	162-0042
Address	27 Waseda-cyo, Shinjuku-ku, Tokyo 162-0044, Japan Green Computing Systems Reserch Organization 603
TEL	03-3203-4427
Homepage URL
Email	jubi@waseda.jp

Sponsor
Institute	Waseda University
Institute
Department

Funding Source
Organization	Waseda University
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	Waseda University Ethics Review Committee
Address	2nd floor, No. 9 Bldg.1-104 Totsuka -cho, Shinjuku-ku, Tokyo 162-0044, Japan
Tel	03-5272-1639
Email	rinri@list.waseda.jp

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	総合東京病院(東京都)

Other administrative information
Date of disclosure of the study information	2020 Year 07 Month 10 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	Preinitiation
Date of protocol fixation	2020 Year 03 Month 30 Day
Date of IRB
Anticipated trial start date	2020 Year 08 Month 01 Day
Last follow-up date	2025 Year 03 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	2020 Year 07 Month 10 Day
Last modified on	2020 Year 07 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046904