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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034403
Receipt No. R000039226
Scientific Title Development of robot application for upper limb rehabilitation in hemiplegia or cervical spondylotic myelopathy patients
Date of disclosure of the study information 2018/11/01
Last modified on 2018/10/30

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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
Middle name
Last name Naonobu Takahira
Organization School of Allied Health Sciences, Kitasato University
Division name Physical Therapy Course, Department of Rehabilitation
Zip code
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
Middle name
Last name Naonobu Takahira
Organization School of Allied Health Sciences, Kitasato University
Division name Physical Therapy Course, Department of Rehabilitation
Zip code
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
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 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 Preinitiation
Date of protocol fixation
2018 Year 09 Month 01 Day
Date of IRB
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
2018 Year 10 Month 30 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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