UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035875
Receipt No. R000040871
Scientific Title Development and validation of upper limb function training robot for hemiplegic patients - Examination of muscle synergy by electromyogram analysis-
Date of disclosure of the study information 2019/02/14
Last modified on 2019/08/16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Development and validation of upper limb function training robot for hemiplegic patients - Examination of muscle synergy by electromyogram analysis-
Acronym Study on upper limb rehabilitation robot in patients with hemiplegia
Scientific Title Development and validation of upper limb function training robot for hemiplegic patients - Examination of muscle synergy by electromyogram analysis-
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 aim for the development of a system that evaluates motor learning by muscle synergy analysis of stroke patients and provides appropriate rehabilitation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes ï½¥muscle synergy

Key secondary outcomes Stroke Impairment Assessment Set (SIAS)
Brunnstrom Stage
Functional Independence Measure (FIM)
Fugl-Meyer assessment

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 Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Intervention and assessment are performed using Synergy-01.
The frequency of the interventions for inpatients is four times in total at two weeks intervals.
Inpatients are intervened on the same day as the evaluation.
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
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 30

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
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 474-8511
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 Institute of Physical and Chemical Research Brain Science Institute
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization National Center for Geriatrices and Gerontology
Address 7-430, Moriokachou, Obu, Aichi
Tel 0562-46-2311
Email 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
2019 Year 02 Month 14 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
2013 Year 04 Month 23 Day
Date of IRB
2017 Year 11 Month 07 Day
Anticipated trial start date
2017 Year 12 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
2019 Year 02 Month 14 Day
Last modified on
2019 Year 08 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040871

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.