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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025129
Receipt No. R000028898
Scientific Title Effects of Balance Exercise Assist Robot (BEAR) on balance in patients with hemiparetic stroke : a randomized controlled trial.
Date of disclosure of the study information 2016/12/02
Last modified on 2019/03/14

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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
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
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/ctr_e/ctr_view.cgi?recptno=R000028898

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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