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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033299
Receipt No. R000037961
Official scientific title of the study 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 2018/07/05

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Basic information
Official scientific title of the study Development of training methods and verification of effectiveness using upper limb rehabilitation robot in patients with hemiplegia
Title of the study (Brief title) 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 Izumi Kondo
Organization National Center for Geriatrics and Gerontology
Division name Department of Rehabilitation medicine
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 Izumi Kondo
Organization National Center for Geriatrics and Gerontology
Division name Department of Rehabilitation medicine
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 None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2015 Year 08 Month 01 Day
Anticipated trial start date
2015 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 07 Month 05 Day
Last modified on
2018 Year 07 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037961

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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