UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033299 |
|---|---|
| Receipt number | R000037961 |
| Scientific Title | Development of training methods and verification of effectiveness using upper limb rehabilitation robot in patients with hemiplegia |
| Date of disclosure of the study information | 2018/07/05 |
| Last modified on | 2019/07/14 07:41:06 |
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Basic information
Public title
Development of training methods and verification of effectiveness using upper limb rehabilitation robot in patients with hemiplegia
Acronym
Study on upper limb rehabilitation robot in patients with hemiplegia
Scientific Title
Development of training methods and verification of effectiveness using upper limb rehabilitation robot in patients with hemiplegia
Scientific Title:Acronym
Study on upper limb rehabilitation robot in patients with hemiplegia
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop the appropriate training methods and to verify the effectiveness with the upper limb rehabilitation robot in hemiplegic patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Simple Test for Evaluating Hand Function (STEF)
Key secondary outcomes
Stroke Impairment Assessment Set (SIAS)
Brunnstrom Stage
Functional Skills Measure After Paralysis (FSMAP)
Functional Independence Measure (FIM)
Quantified Paralysis Performance Assessment (QPPA)
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The interventions for the subjects are the training with upper limb rehabilitation robot (ReoGo-J).
The frequency of the interventions for inpatients is 40 minutes a day and six times a week. The period is two weeks. The frequency of the interventions for outpatients is 40 minutes a day, two times a week. The period is six weeks. The times of all the interventions are 12 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inpatients with hemiplegia in a rehabilitation ward or outpatient with hemiplegia
The general condition is stable
Patients can keep sitting
Informed-consent has been obtained
Key exclusion criteria
High-blood pressure(systolic blood pressure >= 180 mmHg or diastolic blood pressure >= 120 mmHg or resting heart rate >= 120/min)
Restricted exercise due to heart function or respiratory function disorder
Hearing or visual impairment
Dementia or severe higher brain dysfunction
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Izumi |
| Middle name | |
| Last name | Kondo |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Rehabilitation medicine
Zip code
474-8511
Address
7-430, Morioka-cho, Obu-shi, Aichi, 474-8511, Japan
TEL
0562-46-2311
ik7710@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Izumi |
| Middle name | |
| Last name | Kondo |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Rehabilitation medicine
Zip code
474-8511
Address
7-430, Morioka-cho, Obu-shi, Aichi, 474-8511, Japan
TEL
0562-46-2311
Homepage URL
ik7710@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Geriatrics and Gerontology
Address
7-430, Moriokachou Obu
Tel
0562-46-2311
ik7710@ncgg.go.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
| 2018 | Year | 07 | Month | 05 | 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
| 2015 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2020 | 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
| 2018 | Year | 07 | Month | 05 | Day |
Last modified on
| 2019 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037961
