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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028559
Receipt No. R000030445
Scientific Title Examination about the clinical response of a walk assistance robot, the walk exercise assist for the stroke one side lower limbs paralytic
Date of disclosure of the study information 2017/08/07
Last modified on 2017/08/07

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Basic information
Public title Examination about the clinical response of a walk assistance robot, the walk exercise assist for the stroke one side lower limbs paralytic
Acronym Examination about the clinical response of a walk assistance robot, the walk exercise assist
Scientific Title Examination about the clinical response of a walk assistance robot, the walk exercise assist for the stroke one side lower limbs paralytic
Scientific Title:Acronym Examination about the clinical response of a walk assistance robot, the walk exercise assist
Region
Japan

Condition
Condition stroke
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Use walking practice assist for walking practice of stroke paralysis patients and examine whether the practice effect is superior to walking exercises only with conventional orthosis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Walking improvement efficiency
Functional Independence Measure(FIM)
Key secondary outcomes 10m walking time
10m walking steps
Walking figure
Timed Up and Go test(TUGT)
Dynamic Gait Index(DGI)
Stroke Impairment Assessment Set(SIAS)
modified Ashworth scale(MAS)
Sensory function
Walking video

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Gait exercise assist robot
Interventions/Control_2 conventional walking training
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
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Within 3 months after onset of stroke
Three or less of Functional Independence Measure(FIM)
walking items
Weight is 40kg or more and less than 80kg
Height not less than 140cm and less than 190cm
Stroke Impairment Assessment Set(SIAS) lower limb total
is 3 points or less
Key exclusion criteria 1.Severe sensory aphasia(FIM Understanding is 2 points or less)
2.Severe higher brain dysfunction(FIM Social exchange, memory, problem solving is 2 points or less)
3.High blood pressure with poor control(Systolic blood pressure of 160mmHg or more or diastolic blood pressure of 100mmHg or more)
4.At resting heart beat 100 times / min or more
5.Motor restriction by cardiac function, respiratory dysfunction
6.Lower limb circulation disorder and diabetic peripheral neuropathy
7.Severe joint contracture and deformity
8.For some reason exercise restriction
9.Some sight impairment that impedes training, hearing disorder
10.Possibility of contaminating robots
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeru Sonoda
Organization Fujita Health University Nanakuri Memorial Hospital
Division name Department of Rehabilitation Medicine II , School of Medicine
Zip code
Address 424-1, Ohdori, Tsu-shi, Mie
TEL 059-252-1555
Email doctor.sonoda@nifty.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira Suzuki
Organization Fujita Health University Nanakuri Memorial Hospital
Division name Department of Rehabilitation
Zip code
Address 424-1, Ohdori, Tsu-shi, Mie
TEL 059-252-1555
Homepage URL
Email asuzuki@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University
Institute
Department

Funding Source
Organization Toyota Motor Corporation
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 08 Month 07 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
2017 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 08 Month 07 Day
Last modified on
2017 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030445

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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