UMIN-CTR Clinical Trial

Basic information
Public title	A research on combined effects of kinesthetic illusion induced by visual stimulation and neuromuscular electrical stimulation for hemiparetic patients with stroke.
Acronym	A research on the effect of kinesthetic illusion for patients with stroke.
Scientific Title	A research on combined effects of kinesthetic illusion induced by visual stimulation and neuromuscular electrical stimulation for hemiparetic patients with stroke.
Scientific Title:Acronym	A research on the effect of kinesthetic illusion for patients with stroke.
Region	Japan

Condition
Condition	Hemiparetic patients with stroke.
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of combination therapy of kinesthetic illusion and neuromuscular electrical stimulation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Motor functions will be assessed before and after intervention. Motor function assessment: Fugl-Meyer Assessment upper limb exercise items and Action Research Assessment Test.
Key secondary outcomes	Motor functions will be assessed before and after intervention. Motor function assessment: Stroke Impairment Assessment set upper limb exercise items and Box and Block Test. Frequency of use in daily life: Motor Activity Log. Muscle spasticity of upper limb: Modified Ashworth Scale.

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	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	A combination of kinesthetic illusion induced by visual stimulation and neuromuscular electrical stimulation is performed for 10 minutes x 2 sets for 10 days on weekdays. The visual stimulation is a video of the finger flexion and extension movement. Neuromuscular electrical stimulation is performed at approximately 1.1 to 1.2 times the motor threshold of the extensor digitorum communis.
Interventions/Control_2	Therapeutic exercise for 20 minutes on upper limb for 10 days on weekdays.
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	Patients within 6 months after stroke onset. First stroke patient. 20 years or older. Patients who have obtained written consent for participation in this study.
Key exclusion criteria	Those who have difficulty in understanding the purpose and method of the study (regardless of cognitive or impaired high degree brain function). Patients with aphasia. SIAS distal item is 0. Patients who can not take a time for physical and occupational therapy for more than 2 hours per day during the study period. Those who are contraindicated for exercise therapy. Those who are contraindicated for Magnetoencephalography and Magnetic Resonance Imaging.
Target sample size	64

Research contact person
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, Shinjuku-ku, Tokyo, Japan
TEL	+81-3-5363-3833
Email	f-kaneko@keio.jp

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

Sponsor
Institute	Keio University
Institute
Department

Funding Source
Organization	Japan society for the promotion of science
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	Keio University School of Medicine Ethics Committee
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel	03-5363-3505
Email	med-rinri-jimu@adst.keio.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	社会医療法人十勝リハビリテーションセンター（北海道）、社会医療法人恩賜財団済生会東神奈川リハビリテーション病院（神奈川）、医療法人社団保健会東京湾岸リハビリテーション病院（千葉）

Other administrative information
Date of disclosure of the study information	2020 Year 02 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	Enrolling by invitation
Date of protocol fixation	2019 Year 09 Month 30 Day
Date of IRB	2019 Year 12 Month 06 Day
Anticipated trial start date	2020 Year 01 Month 01 Day
Last follow-up date	2029 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 01 Month 24 Day
Last modified on	2020 Year 01 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042894