UMIN-CTR Clinical Trial

Basic information
Public title	Effects of Balance Exercise Assist Robot (BEAR) on balance in patients with hemiparetic stroke : a randomized controlled trial.
Acronym	Effects of Balance Exercise Assist Robot (BEAR) on balance in patients with hemiparetic stroke : a randomized controlled trial.
Scientific Title	Effects of Balance Exercise Assist Robot (BEAR) on balance in patients with hemiparetic stroke : a randomized controlled trial.
Scientific Title:Acronym	Effects of Balance Exercise Assist Robot (BEAR) on balance in patients with hemiparetic stroke : a randomized controlled trial.
Region	Japan

Condition
Condition	hemiparetic stroke
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aims of the study are 1) to examine whether the intervention using the Balance Exercise Assistance Robot (BEAR) in addition to usual rehabilitation program improve the balance in patients with hemiparetic stroke compared with usual rehabilitation alone, 2) to examine whether the additive effects of the balance training using the BEAR is superior than that of the conventional balance training.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Mini-Balance Evaluation Systems Test
Key secondary outcomes	Cross test Tandem gait Muscle strength Functional Independence Measure Stroke Impairment Assessment Set Fall Efficacy Scale - International Questionnaire Falls

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Balance training with the BEAR in addition to usual rehabilitation program
Interventions/Control_2	Conventional balance training in addition to usual rehabilitation program
Interventions/Control_3	Usual rehabilitation program alone
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	40 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Consent to participate in the study 2)Age between 40 and 80 years 3)First-ever hemiparetic stroke, from 1 to 3 months after the onset of stroke. 4)Weight, 35 - 100kg; height, 140 - 190cm. 5)No apparent paralysis in the unaffected limbs. 6)No severe contractures, and deformity in the lower limbs 7)Able to stand still on the BEAR 8)The score of the Functional Ambulation Categories is 2 or more.
Key exclusion criteria	1)Inability to follow instructions due to aphasia and/or cognitive deficits. 2)Medical conditions that might deteriorate with exercise. 3)Physical conditions that might disturb the safe training, 4)The score of the Mini-BESTest is 25 points or more 5)The patients who are judged as inappropriate for participating in the study by his/her physician.
Target sample size	60

Research contact person
Last name of lead principal investigator	1st name Seigo Middle name Last name Inoue
Organization	Tokyo Bay Rehabilitation Hospital
Division name	Division of Physical therapy
Zip code	275-0026
Address	4-1-1 Yatsu,Narashino-shi,Chiba
TEL	047-453-9010
Email	s.inoue@wanreha.net

Public contact
1st name of contact person	1st name Seigo Middle name Last name Inoue
Organization	Tokyo Bay Rehabilitation Hospital
Division name	Division of Physical therapy
Zip code	275-0026
Address	4-1-1 Yatsu,Narashino-shi,Chiba
TEL	047-453-9010
Homepage URL
Email	s.inoue@wanreha.net

Sponsor
Institute	Tokyo Bay Rehabilitation Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Department of Rehabilitation Medicine I , Fujita Health University School of Medicine
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics committee of Tokyo Bay Rehabilitation Hospital
Address	4-1-1 Yatsu,Narashino-shi,Chiba
Tel	047-453-9000
Email	shinsakai@wanreha.net

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	東京湾岸リハビリテーション病院(千葉県) Tokyo Bay Rehabilitation Hospital (Chiba)

Other administrative information
Date of disclosure of the study information	2016 Year 12 Month 02 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	2016 Year 11 Month 14 Day
Date of IRB	2016 Year 07 Month 27 Day
Anticipated trial start date	2016 Year 12 Month 05 Day
Last follow-up date	2019 Year 02 Month 28 Day
Date of closure to data entry	2019 Year 03 Month 01 Day
Date trial data considered complete	2019 Year 03 Month 05 Day
Date analysis concluded	2019 Year 03 Month 14 Day

Other
Other related information

Management information
Registered date	2016 Year 12 Month 02 Day
Last modified on	2019 Year 03 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028898