UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015948 |
|---|---|
| Receipt number | R000018545 |
| Scientific Title | Does training sitting balance on a platform tilted 10 degrees to the weak side improve trunk control in the acute phase after stroke? A randomized, controlled trial |
| Date of disclosure of the study information | 2014/12/15 |
| Last modified on | 2014/12/15 11:42:54 |
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Basic information
Public title
Does training sitting balance on a platform tilted 10 degrees to the weak side improve trunk control in the acute phase after stroke? A randomized, controlled trial
Acronym
Does training sitting balance on a platform tilted 10 degrees to the weak side improve trunk control in the acute phase after stroke? A randomized, controlled trial
Scientific Title
Does training sitting balance on a platform tilted 10 degrees to the weak side improve trunk control in the acute phase after stroke? A randomized, controlled trial
Scientific Title:Acronym
Does training sitting balance on a platform tilted 10 degrees to the weak side improve trunk control in the acute phase after stroke? A randomized, controlled trial
Region
| Japan |
Condition
Condition
Acute stroke patients
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effectiveness of training sitting balance on a platform tilted 10 degrees to the weak side and on a horizontal platform in stroke patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stroke Impairment Assessment Set
Trunk Control Test
Motion analysis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The experimental group sat without leg support on a platform tilted 10 degrees to the paretic side in the frontal plane. They were asked to move their trunk laterally from the paretic side to the non-paretic side. This training was performed 60 times per session, with 6 sessions in one week.
Interventions/Control_2
The control group sat without leg support on a horizontal platform. They were asked to move their trunk laterally from the paretic side to the non-paretic side. This training was performed 60 times per session, with 6 sessions in one week.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) no past history of stroke
(2) supratentorial lesion of the brain
(3) stable neurological symptoms and general condition
(4) ability to sit without support
(5) the trunk control test was not maximal at the start of study
(6) no dementia or psychiatric disorder
(7) ability to understand instructions
(8) no orthopedic problem that would interfere with the ability to perform lateral sitting training
(9) able to provide informed consent
Key exclusion criteria
Cases that do not meet the inclusion criteria.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Fujino |
Organization
Saitama Medical University International Medical Center
Division name
Department of Rehabilitation
Zip code
Address
1397-1, Yamane, Hidaka, Saitama 350-1298, Japan
TEL
042-984-4367
yujifuji@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuji Fujino |
Organization
Saitama Medical University International Medical Center
Division name
Department of Rehabilitation
Zip code
Address
1397-1, Yamane, Hidaka, Saitama 350-1298, Japan
TEL
042-984-4367
Homepage URL
yujifuji@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University International Medical Center
Institute
Department
Personal name
Funding Source
Organization
none
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 15 | 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
| 2010 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 15 | Day |
Last modified on
| 2014 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018545
