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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026622
Receipt No. R000030422
Scientific Title Kinematic analysis about changes of postural control with proficiency of the Balance Exercise Assist Robot exercises.
Date of disclosure of the study information 2017/06/01
Last modified on 2019/02/28

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Basic information
Public title Kinematic analysis about changes of postural control with proficiency of the Balance Exercise Assist Robot exercises.
Acronym Kinematic analysis about changes of postural control with proficiency of the Balance Exercise Assist Robot exercises.
Scientific Title Kinematic analysis about changes of postural control with proficiency of the Balance Exercise Assist Robot exercises.
Scientific Title:Acronym Kinematic analysis about changes of postural control with proficiency of the Balance Exercise Assist Robot exercises.
Region
Japan

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

Objectives
Narrative objectives1 The aim is to investigate the kinematic changes in postural control with adaptation of exercise using Balance Exercise Assist Robot
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Difference between maximum flexion and maximum extension of the hip joint
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 The subject plays three games at random which games are tennis, ski, and rodeo.The subject plays each games at the highest level until the score reaches plateau.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Inclusion criteria is as follow: 1) subjects who can operate Balance Exercise Assist Robot.
Key exclusion criteria Exclusion criteria is as following: 1) Subject have a history of stroke, neuromuscular disease, or Musculoskeletal disease, 2) Subjects have a risk to their health by exercise intensity.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuo Mikami
Organization Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name Department of Rehabilitation Medicine
Zip code
Address 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL 075-251-5324
Email reha@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daisuke Imoto
Organization Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name Department of Rehabilitation Medicine
Zip code
Address 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL 075-251-5324
Homepage URL
Email reha@koto.kpu-m.ac.jp

Sponsor
Institute Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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 06 Month 01 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 Completed
Date of protocol fixation
2017 Year 03 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 06 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 03 Month 21 Day
Last modified on
2019 Year 02 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030422

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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