UMIN-CTR Clinical Trial

Basic information
Public title	Effect of kinesthetic illusion induced by visual stimulation in patients with stroke
Acronym	Effect of kinesthetic illusion induced by visual stimulation in patients with stroke
Scientific Title	Effect of kinesthetic illusion induced by visual stimulation in patients with stroke
Scientific Title:Acronym	Effect of kinesthetic illusion induced by visual stimulation in patients with stroke
Region	Japan

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

Objectives
Narrative objectives1	To investigate the effects of therapy with kinesthetic illusion induced by visual stimulation five days per week for two weeks on the paretic upper extremity after stroke.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of upper extremity function (Fugl-Meyer Assessment, etc)
Key secondary outcomes	Magnetoencephalography

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	20 minutes for kinesthetic illusion induced by visual stimulation five days per week for two weeks
Interventions/Control_2
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	18 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	1) ischemic or hemorrhagic stroke 2) more than 90 days after stroke onset 3) motor paresis on upper extremity 4) ability to flex fingers partially, inability to extend fingers 5) not severe contracture on finger joints
Key exclusion criteria	1) severe medical comorbidities unable to perform the therapy 2) severe cognitive or psychiatric disorder 3) pacemaker or implantable cardioverter defibrillators 4) history of epilepsy within 30 days 5) history of specific neurorehabilitation such as rTMS, tDCS, functional electrical stimilation, and repetitive facilitative exercise, and constraint induced movement therapy within 30 days 6) history of botulinum toxin injection or nerve block within 30 days
Target sample size	11

Research contact person
Name of lead principal investigator	1st name Middle name Last name Ryosuke Takahashi
Organization	Hokuto Hospital
Division name	Department of Medical Technology
Zip code
Address	7-5 Kisen, Inada-cho, Obihiro-shi, Hokkaido
TEL	0155-48-8000
Email	hokutopt.takahashi@gmail.com

Public contact
Name of contact person	1st name Middle name Last name Ryosuke Takahashi
Organization	Hokuto Hospital
Division name	Department of Medical Technology
Zip code
Address	7-5 Kisen, Inada-cho, Obihiro-shi, Hokkaido
TEL	0155-48-8000
Homepage URL
Email	hokutopt.takahashi@gmail.com

Sponsor
Institute	Hokuto Hospital
Institute
Department

Funding Source
Organization	Hokuto Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2019 Year 02 Month 25 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	Completed
Date of protocol fixation	2019 Year 02 Month 01 Day
Date of IRB	2018 Year 02 Month 28 Day
Anticipated trial start date	2018 Year 06 Month 01 Day
Last follow-up date	2020 Year 01 Month 30 Day
Date of closure to data entry	2020 Year 02 Month 01 Day
Date trial data considered complete	2020 Year 02 Month 01 Day
Date analysis concluded	2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2019 Year 02 Month 23 Day
Last modified on	2020 Year 08 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040988