UMIN-CTR Clinical Trial

Basic information
Public title	Verification of the effect of exercise support device and VR integrated system for hemiplegic patients
Acronym	Verification of the effect of exercise support device and VR integrated system for hemiplegic patients
Scientific Title	Verification of the effect of exercise support device and VR integrated system for hemiplegic patients
Scientific Title:Acronym	Verification of the effect of exercise support device and VR integrated system for hemiplegic patients
Region	Japan

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

Objectives
Narrative objectives1	Verification of the effectiveness of the developed system
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Position, Velocity, Acceleration, and EMG of the Lower Extremity During Flexion / Extension Exercise Before and After Exercise Training
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Device,equipment
Interventions/Control_1	Conducted training to repeat lower extremity flexion and extension movements by rehabilitation system for about 30 seconds x 10 times
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	Hemiplegia patients who want to use this system and meet the following criteria: 1. Brunstrom stage of lower limb from 3 to 5 2. Those without higher brain dysfunction 3. The physician and physiotherapist can determine that there is no problem in conducting the test
Key exclusion criteria	1. Uncontrolled heart failure 2. Acute myocardial infarction 3. Active myocarditis or pericarditis 4. Unstable angina 5. Acute systemic embolism or pulmonary embolism 6. Acute infection 7. Thrombophlebitis 8. Ventricular tachycardia or refractory ventricular arrhythmia 9. Severe ventricular outflow tract obstruction 10. Uncontrolled arterial or pulmonary hypertension 11. Being included in another intervention study at the same time (verify with your physiotherapist) Exclusion criteria are determined by the attending physician
Target sample size	6

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

Other administrative information
Date of disclosure of the study information	2020 Year 04 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	Preinitiation
Date of protocol fixation	2019 Year 12 Month 18 Day
Date of IRB
Anticipated trial start date	2022 Year 04 Month 01 Day
Last follow-up date	2026 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 03 Month 17 Day
Last modified on	2021 Year 10 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045357