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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027124
Receipt No. R000031080
Scientific Title Efficacy of balance exercise using Balance Exercise Assist Robot for the patients with balance disorder
Date of disclosure of the study information 2017/06/01
Last modified on 2019/02/28

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Basic information
Public title Efficacy of balance exercise using Balance Exercise Assist Robot for the patients with balance disorder
Acronym Efficacy of balance exercise using Balance Exercise Assist Robot
Scientific Title Efficacy of balance exercise using Balance Exercise Assist Robot for the patients with balance disorder
Scientific Title:Acronym Efficacy of balance exercise using Balance Exercise Assist Robot
Region
Japan

Condition
Condition Patients with balance disorder
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aim to examine the efficacy of balance exercise using Balance Exercise Assist Robot compared with conventional balance exercise.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Functional Reach Test
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
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
Interventions/Control_1 Balance exercises using Balance Exercise Assist Robot were performed for eight days, three times a day. Three methods of balance exercise using a BEAR were devised: exercise moving the center of gravity (Front and back, right and left) and exercise against perturbation.
Interventions/Control_2 Control group were performed conventional balance exercise for eight days, three times a day. Methods of balance exercise were Muscle strengthening exercise, quiet standing exercise, dynamic balance exercise, gait exercise.
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
90 years-old >=
Gender Male and Female
Key inclusion criteria Inclusion criteria is as following: experienced myelopathy over 6 months, Functional Independence Measure of gait score more than 6, and enable stopping on Balance Exercise Assist Robot.
Key exclusion criteria Exclusion criteria is as following: 1) Those that do not follow the staff instructed, 2) Those that have a risk of deterioration of physical situation by exercise, 3) those that have a risk of inhibition to safety exercise by physical situation.
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuo Milami
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, 602-8566, Japan
TEL +81-75-251-5324
Email reha@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Suzuyo Ohashi
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, 602-8566, Japan
TEL +81-75-251-5324
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 Kyoto Prefectural University of Medicine
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
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
2015 Year 03 Month 03 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 30 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 04 Month 25 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=R000031080

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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