UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of balance exercise using Balance Exercise Assist Robot for the patients with balance disorder
Title of the study (Brief title)	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	Yasuo Milami
Organization	Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name	Department of Rehabilitation Medicine
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	Suzuyo Ohashi
Organization	Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name	Department of Rehabilitation Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 03 Month 03 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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