UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical trial of balance exercise "Assist"
Title of the study (Brief title)	Balance Exercise Assist
Region	Japan

Condition
Condition	Stroke, Parkinson disease, Osteoarthrosis
Classification by specialty	Medicine in general Neurology Orthopedics Neurosurgery Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the effect on balance response between ordinary exercise and exercise with barance exercise assist
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	muscle strength of lower limbs, static balance, walking speed
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
Interventions/Control_1	use of balance exercise assist
Interventions/Control_2	ordinary balance 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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	patients with dysequilibrium
Key exclusion criteria	patients with cardiopulmonary dysfunction and severe deformities in their limbs
Target sample size	40

Research contact person
Name of lead principal investigator	Masanori Nagaoka
Organization	Juntendo University
Division name	Rehabilitation Medicine
Address	2-1-1, Hongo, Bunkyo-ku, tokyo
TEL	03-3813-3111
Email	nagaokam@juntendo.ac.jp

Public contact
Name of contact person	Masanori Nagaoka
Organization	Juntendo University
Division name	Rehabilitation Medicine
Address	2-1-1, Hongo, Bunkyo-ku, tokyo
TEL	03-3813-3111
Homepage URL
Email	nagaokam@juntendo.ac.jp

Sponsor
Institute	Juntendo University
Institute
Department

Funding Source
Organization	Juntendo University, Faculty of Medicine
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	順天堂大学医学部附属順天堂医院

Other administrative information
Date of disclosure of the study information	2015 Year 02 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 02 Month 20 Day
Anticipated trial start date	2015 Year 04 Month 01 Day
Last follow-up date	2016 Year 02 Month 29 Day
Date of closure to data entry	2016 Year 03 Month 31 Day
Date trial data considered complete	2017 Year 03 Month 31 Day
Date analysis concluded	2017 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 02 Month 20 Day
Last modified on	2017 Year 06 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019252