UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028559 |
|---|---|
| Receipt number | 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 00:13:00 |
* 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
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
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
asuzuki@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
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
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
Value
https://center6.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 |
