UMIN-CTR Clinical Trial

Basic information
Public title	Development of robot application for upper limb rehabilitation in hemiplegia or cervical spondylotic myelopathy patients
Acronym	Development of robot application for upper limb rehabilitation in hemiplegia or cervical spondylotic myelopathy patients
Scientific Title	Development of robot application for upper limb rehabilitation in hemiplegia or cervical spondylotic myelopathy patients
Scientific Title:Acronym	Development of robot application for upper limb rehabilitation in hemiplegia or cervical spondylotic myelopathy patients
Region	Japan

Condition
Condition	Cerebral vascular disease, cervical spondylotic myelopathy
Classification by specialty	Neurology Orthopedics Neurosurgery Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to examine points to be improved and effects of the robot application for upper limb rehabilitation in hemiplegia or cervical spondylotic myelopathy patients.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The favorable situation and the inappropriate situation that occurred based on specifications of the application (during the intervention with the application to the patients)
Key secondary outcomes	1)Unexpected malfunction of the application (during the intervention with the application to the patients) 2)questionnaire (after an intervention period) 3) Fugl-Meyer Assessment (before and after the intervention period) 4) Motor Activity Log (before and after the intervention period) 5) The amount of activity of the paralyzed upper limb (before and after the intervention period)

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Robot application for upper limb rehabilitation (2 weeks. 20 minutes per once, once per 1 day, 5 days within 1 week)
Interventions/Control_2	Conventional rehabilitation (2 weeks. 20 minutes per once, once per 1 day, 5 days within 1 week)
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	Inpatients at a convalescence rehabilitation ward in Kitasato University East Hospital who had an onset of cerebral vascular diseases or cervical spondylotic myelopathy before 1 month or earlier and have resulted upper limb motor paralysis
Key exclusion criteria	Inpatients who sustained upper limb motor paralysis before hospitalization or inpatients with cognitive dysfunction or higher brain dysfunction
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Naonobu Middle name Last name Takahira
Organization	School of Allied Health Sciences, Kitasato University
Division name	Physical Therapy Course, Department of Rehabilitation
Zip code	252-0373
Address	Kitasato 1-15-1, Minami-ku, Sagamihara, Kanagawa
TEL	042-778-8111
Email	takahira@med.kitasato-u.ac.jp

Public contact
Name of contact person	1st name Naonobu Middle name Last name Takahira
Organization	School of Allied Health Sciences, Kitasato University
Division name	Physical Therapy Course, Department of Rehabilitation
Zip code	252-0373
Address	Kitasato 1-15-1, Minami-ku, Sagamihara, Kanagawa
TEL	042-778-8111
Homepage URL
Email	takahira@med.kitasato-u.ac.jp

Sponsor
Institute	Kitasato University
Institute
Department

Funding Source
Organization	Industry Promotion Division, Industry Department, Industry and Labor Bureau, Kanagawa Prefectural Government
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor	Shanti Co., Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The Kitasato Institute, Clinical Research Review Board
Address	Kitasato 1-15-1, Minami-ku, Sagamihara, Kanagawa
Tel	042-778-8273
Email	rinrib@med.kitasato-u.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	北里大学東病院（神奈川県）/Kitasato University East Hospital (Kanagawa)

Other administrative information
Date of disclosure of the study information	2018 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	Completed
Date of protocol fixation	2018 Year 09 Month 01 Day
Date of IRB	2018 Year 11 Month 07 Day
Anticipated trial start date	2018 Year 11 Month 12 Day
Last follow-up date	2018 Year 12 Month 14 Day
Date of closure to data entry	2018 Year 12 Month 15 Day
Date trial data considered complete	2018 Year 12 Month 22 Day
Date analysis concluded	2018 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2018 Year 10 Month 08 Day
Last modified on	2020 Year 10 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039226