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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033556
Receipt No. R000038265
Scientific Title Verification of effectiveness using gait exercise assist robot in patients with hemiplegia
Date of disclosure of the study information 2018/07/31
Last modified on 2019/07/31

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Basic information
Public title Verification of effectiveness using gait exercise assist robot in patients with hemiplegia
Acronym Study on gait exercise assist robot in patients with hemiplegia
Scientific Title Verification of effectiveness using gait exercise assist robot in patients with hemiplegia
Scientific Title:Acronym Study on gait exercise assist 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 verify the effectiveness with gait exercise assist robot in severe hemiplegic patients who need knee-ankle-foot orthosis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Functional Independence Measure (FIM)
Key secondary outcomes Stroke Impairment Assessment Set (SIAS),
gait velocity

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 gait exercise assist robot (Wel-walk).
The frequency of the interventions for inpatients is 40 minutes a day and five times a week. The maximum period is eight weeks.
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
Standing and walking training is permitted by the doctor.
Patients require the knee-ankle-foot orthosis to stand and walk by the judgement ofthe rehabilitation doctor.
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 10

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 National Center for Geriatrics and Gerontology
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, Morioka-cho, Obu-shi, Aichi, 474-8511, Japan
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
2018 Year 07 Month 31 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 09 Month 01 Day
Date of IRB
2015 Year 10 Month 01 Day
Anticipated trial start date
2015 Year 09 Month 01 Day
Last follow-up date
2021 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 30 Day
Last modified on
2019 Year 07 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038265

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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