UMIN-CTR Clinical Trial

Basic information
Public title	Clinical studies on the effects of intervention of neuroscience-based physical therapy on patients with stroke
Acronym	Clinical studies on stroke patients
Scientific Title	Clinical studies on the effects of intervention of neuroscience-based physical therapy on patients with stroke
Scientific Title:Acronym	Clinical studies on stroke patients
Region	Japan

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

Objectives
Narrative objectives1	To investigate the effect of kinesthetic illusion induced by visual stimulation on recovery of hemiparesis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Muscle force, Electromyography, Simple test for evaluating hand function (STEF), Fugl-Meyer Assessment (FMA)
Key secondary outcomes	Sensorimotor function (measured using Kinestage), Brunnstrom stage, Action Research Arm Test(ARAT)

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Participants are presented visual stimuli which evoke kinesthetic illusion 20minutes a day for 10 days, in addition to a regular rehabilitation protocol for upper limb (A). Participants undergo a regular rehabilitation for upper limb for 10 days (B).
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	20 years-old <
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Participants should meet the following requirements. 1) Stroke patients who are judged not to have negative risks in participating in the experiment by the physician in charge. 2) Who provides a written informed consent to participate in the experiment. 3) Who does not have cognitive disorders (the score of MMSE should be higher than 21 points)
Key exclusion criteria	Who cannot comfortably sit on a chair for 20 minutes.
Target sample size	50

Research contact person
Last name of lead principal investigator	1st name Fuminari Middle name Last name Kaneko
Organization	Keio University School of Medicine
Division name	Department of Rehabilitation Medicine
Zip code	160-8582
Address	35 Shinanomachi, Shinjyuku, Tokyo, Japan
TEL	+81-3-5363-3833
Email	f-kaneko@keio.jp

Public contact
1st name of contact person	1st name Megumi Middle name Last name Okawada
Organization	Keio University School of Medicine
Division name	Department of Rehabilitation Medicine
Zip code	160-8582
Address	35 Shinanomachi, Shinjyuku, Tokyo, Japan
TEL	+81-3-5363-3833
Homepage URL
Email	m-okawada@keio.jp

Sponsor
Institute	Keio University
Institute
Department

Funding Source
Organization	Japan agency for medical research and development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Sapporo Medical University
Address	17-1 jyonishi, Cyuou-ku,Sapporo
Tel	011-611-2111
Email	rinri@sapmed.ac.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	医療法人社団進和会旭川リハビリテーション病院（北海道） 医療法人社団豊生会東苗穂病院（北海道） 医療法人社団明芳会イムス板橋リハビリテーション病院（東京都） 茨城県立医療大学医科学センター（茨城県）

Other administrative information
Date of disclosure of the study information	2015 Year 11 Month 01 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	2015 Year 11 Month 01 Day
Date of IRB	2012 Year 11 Month 22 Day
Anticipated trial start date	2015 Year 11 Month 01 Day
Last follow-up date	2019 Year 03 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 10 Month 09 Day
Last modified on	2019 Year 03 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021773