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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036287
Receipt No. R000041331
Scientific Title Clinical Application of a novel Robot for separate body weight support treadmill training in poststroke gait disorder
Date of disclosure of the study information 2019/03/26
Last modified on 2019/03/25

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Basic information
Public title Clinical Application of a novel Robot for separate body weight support treadmill training in poststroke gait disorder
Acronym Clinical Application of a novel Robot for separate body weight support treadmill training in poststroke gait disorder
Scientific Title Clinical Application of a novel Robot for separate body weight support treadmill training in poststroke gait disorder
Scientific Title:Acronym Clinical Application of a novel Robot for separate body weight support treadmill training in poststroke gait disorder
Region
Japan

Condition
Condition Stroke
Classification by specialty
Neurology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Treadmill training with or without partial body weight supported (BWS) is a task-oriented training for gait recovery. Previous studies suggest that body weight supported treadmill training (BWSTT) is effective to improve post-stroke gait disorder. Since conventional BWS continuously support both sides of the body, temporal support for each leg according to the gait cycle cannot be optimized. We developed a novel BWS robot to support the right and left body separately using pneumatic artificial muscles. We assessed whether the robot could modulate gait pattern in post-stroke hemiplegia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Symmetry indexes of stance phase and swing phase duration of gait.
Key secondary outcomes Fugl-Meyer Assessment, 10-Meter walk test, Timed-Up and go test, Berg Balance Scale, kinematic data from the BWS robot and motion analysis system

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 Hemiparetic patients with stroke
Key exclusion criteria Dementia(MMSE<24), severe aphasia, severe heart, respiratory, and/or orthopedic diseases, pain
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Ichiro
Middle name
Last name Miyai
Organization Morinomiya Hospital
Division name Neurorehabilitation Research Institute
Zip code 536-0025
Address 2-1-88 Morinomiya, Joto-ku, Osaka City, Osaka, Japan
TEL 8-6-6969-0111
Email miyai@omichikai.or.jp

Public contact
Name of contact person
1st name Yoshida
Middle name
Last name Makoto
Organization Morinomiya Hospital
Division name Officer
Zip code 536-0025
Address 2-1-88 Morinomiya, Joto-ku, Osaka City, Osaka, Japan
TEL 8-6-6969-0111
Homepage URL
Email yoshida@omichikai.or.jp

Sponsor
Institute ATR Computational Neuroscience Labs, Dept. of Brain Robot Interface
Institute
Department

Funding Source
Organization NICT: National Institute of Information and Communications Technology
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization Omichi-kai Social Medical Corporation Ethics Committee
Address 2-1-88 Morinomiya, Joto-ku, Osaka City, Osaka, Japan
Tel 8-6-6969-0111
Email yoshida@omichikai.or.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 森之宮病院(大阪府)

Other administrative information
Date of disclosure of the study information
2019 Year 03 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 Enrolling by invitation
Date of protocol fixation
2019 Year 11 Month 30 Day
Date of IRB
2019 Year 11 Month 28 Day
Anticipated trial start date
2019 Year 11 Month 30 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
2023 Year 12 Month 31 Day
Date trial data considered complete
2023 Year 12 Month 31 Day
Date analysis concluded
2024 Year 03 Month 31 Day

Other
Other related information None

Management information
Registered date
2019 Year 03 Month 25 Day
Last modified on
2019 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041331

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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