UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016591 |
|---|---|
| Receipt number | R000019252 |
| Scientific Title | Clinical trial of balance exercise "Assist" |
| Date of disclosure of the study information | 2015/02/20 |
| Last modified on | 2017/06/29 22:40:06 |
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Basic information
Public title
Clinical trial of balance exercise "Assist"
Acronym
Balance Exercise Assist
Scientific Title
Clinical trial of balance exercise "Assist"
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Masanori Nagaoka |
Organization
Juntendo University
Division name
Rehabilitation Medicine
Zip code
Address
2-1-1, Hongo, Bunkyo-ku, tokyo
TEL
03-3813-3111
nagaokam@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masanori Nagaoka |
Organization
Juntendo University
Division name
Rehabilitation Medicine
Zip code
Address
2-1-1, Hongo, Bunkyo-ku, tokyo
TEL
03-3813-3111
Homepage URL
nagaokam@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Published
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
| 2015 | Year | 02 | Month | 20 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019252
