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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028342
Receipt No. R000032415
Scientific Title Clinical evaluation of the support device integrating exercise and perception that compatibilizes exercise and sensory support in walking rehabilitation of stroke patients
Date of disclosure of the study information 2017/07/26
Last modified on 2017/07/23

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Basic information
Public title Clinical evaluation of the support device integrating exercise and perception that compatibilizes exercise and sensory support in walking rehabilitation of stroke patients
Acronym Clinical evaluation of the support device integrating exercise and perception that compatibilizes exercise and sensory support in walking rehabilitation of stroke patients
Scientific Title Clinical evaluation of the support device integrating exercise and perception that compatibilizes exercise and sensory support in walking rehabilitation of stroke patients
Scientific Title:Acronym Clinical evaluation of the support device integrating exercise and perception that compatibilizes exercise and sensory support in walking rehabilitation of stroke patients
Region
Japan

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

Objectives
Narrative objectives1 We verify the rehabilitation effect by walking training using an exercise support device that supports ankle joints by artificial muscle and sensory support device that biofeedback foot pressure during walking as a vibration stimulus to trunk
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Gait speed(immediately after intervention)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Usual gait rehabilitation training(Use Period:None)
Interventions/Control_2 Gait rehabilitation training patient's using the support device integrating exercise and perception (Use Period: 1 day(20 min))
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
75 years-old >=
Gender Male and Female
Key inclusion criteria Patient who agree to the clinical test and meet the following conditions.
1. Patient's recovery stage is Brunnstrom stage 3/4/5
2. The patient has no higher brain dysfunction.
3. Primary doctor and therapist allowed patients to the gait training.
Key exclusion criteria The patient has the following serious condition
1.Uncontrollable heart failure
2.Acute myocardial infarction
3.Myocarditis,pericarditis
4.Angina pectoris
5.Acute embolism, pulmonary embolism
6.Acute infection
7.Thrombophlebitis
8.Ventricular tachycardia, ventricular arrhythmia
9.Severe ventricular outflow tract obstruction
10.Uncontrollable arterial hypertension, pulmonary hypertension
11.Those who are included in the subject of other intervention studies at the same time
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyasu Iwata
Organization Waseda university
Division name Faculty science and engineering
Zip code
Address 27 Waseda-cyo, Shinjuku-ku, Tokyo 162-0044, Japan Green Computing Systems Reserch Organization 603 Prof. Iwata Lab.
TEL 03-3203-4427
Email jubi@waseda.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyasu Iwata
Organization Waseda university
Division name Faculty science and engineering
Zip code
Address 27 Waseda-cyo, Shinjuku-ku, Tokyo 162-0044, Japan Green Computing Systems Reserch Organization 603 P
TEL 03-3203-4427
Homepage URL
Email jubi@waseda.jp

Sponsor
Institute Waseda university
Institute
Department

Funding Source
Organization Waseda University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 総合東京病院(東京都)

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 26 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 Preinitiation
Date of protocol fixation
2017 Year 07 Month 23 Day
Date of IRB
Anticipated trial start date
2018 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 07 Month 23 Day
Last modified on
2017 Year 07 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032415

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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