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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040578
Receipt No. R000046315
Scientific Title Study on task difficulty setting for upper limb rehabilitation robot
Date of disclosure of the study information 2020/06/01
Last modified on 2021/06/07

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Basic information
Public title Study on task difficulty setting for upper limb rehabilitation robot in patients with hemiplegia
Acronym Study on task difficulty setting for upper limb rehabilitation robot
Scientific Title Study on task difficulty setting for upper limb rehabilitation robot
Scientific Title:Acronym Study on task difficulty setting for upper limb rehabilitation robot
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 examine the relation between the number of task achievement and the severity of paralysis, and to develop appropriate training methods through task difficulty setting for upper limb rehabilitation robot.
Basic objectives2 Others
Basic objectives -Others Provision of appropriate training method according to characteristic of hemiplegia after stroke.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Number of task achievement with upper limb rehabilitation robot
Key secondary outcomes Stroke Impairment Assessment Set (SIAS)
Fugl Meyer Assessment Scale (FMA)
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 The intervention for the subjects are the training with upper limb rehabilitation robot (ReoGo-J).
The intervention is one time and there are 9 tasks. The evaluation is the number of each task achievement.
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 more than 180 mmHg or diastolic blood pressure more than 120 mmHg or resting heart rate more than 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 100

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 4748511
Address 7-430, Morioka-cho, Obu-shi, Aichi, 474-8511, Japan
TEL 0562-46-2311
Email 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 4748511
Address 7-430, Morioka-cho, Obu-shi, Aichi, 474-8511, Japan
TEL 0562-46-2311
Homepage URL
Email ik7710@ncgg.go.jp

Sponsor
Institute National Center for Geriatrics and Gerontology
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
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, Morioka-cho, Obu-shi, Aichi, 474-8511, Japan
Tel 0562-46-2311
Email rehab@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
2020 Year 06 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 Enrolling by invitation
Date of protocol fixation
2020 Year 05 Month 01 Day
Date of IRB
2020 Year 04 Month 17 Day
Anticipated trial start date
2020 Year 06 Month 01 Day
Last follow-up date
2025 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information By May 31, 2021, 19 cases had been measured. The distribution of SIAS is 0: 0, 1: 1, 2: 4, 3: 2, 4: 5, and 5: 7, and there are many cases of mild motor paralysis. In the future, we would like to secure a wide range of cases, including cases with moderate to severe motor paralysis.

Management information
Registered date
2020 Year 05 Month 29 Day
Last modified on
2021 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046315

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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