UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination about the clinical response of a walk assistance robot, the walk exercise assist for the stroke one side lower limbs paralytic
Title of the study (Brief title)	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	Shigeru Sonoda
Organization	Fujita Health University Nanakuri Memorial Hospital
Division name	Department of Rehabilitation Medicine II , School of Medicine
Address	424-1, Ohdori, Tsu-shi, Mie
TEL	059-252-1555
Email	doctor.sonoda@nifty.ne.jp

Public contact
Name of contact person	Akira Suzuki
Organization	Fujita Health University Nanakuri Memorial Hospital
Division name	Department of Rehabilitation
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 04 Month 01 Day
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

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Publication of results	Unpublished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