UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034403 |
|---|---|
| Receipt number | 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 | 2020/10/14 09:56:08 |
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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 | 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
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
takahira@med.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039226
