UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025129 |
|---|---|
| Receipt number | 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 18:59:15 |
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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
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
s.inoue@wanreha.net
Sponsor or person
Institute
Tokyo Bay Rehabilitation Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028898
