UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040902 |
|---|---|
| Receipt number | R000046703 |
| Scientific Title | Effects of dynamic sitting exercise with delayed visual feedback in early phase after stroke |
| Date of disclosure of the study information | 2020/06/26 |
| Last modified on | 2022/07/06 16:13:27 |
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Basic information
Public title
Effects of dynamic sitting exercise with delayed visual feedback in early phase after stroke
Acronym
Effects of dynamic sitting exercise with delayed visual feedback in early phase after stroke
Scientific Title
Effects of dynamic sitting exercise with delayed visual feedback in early phase after stroke
Scientific Title:Acronym
Effects of dynamic sitting exercise with delayed visual feedback in early phase after stroke
Region
| Japan |
Condition
Condition
First stroke patient with unilateral motor deficits
Classification by specialty
| Neurology | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of dynamic sitting exercise to anteroposterior and mediolateral direction with delayed visual feedback in early phase after stroke
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Postural Assessment Scale for Stroke
Key secondary outcomes
Dynamic sitting task
Sit-to-stand task
Change of center of pressure movement in the daily intervention
Stroke Impairment Assessment Set
Trunk Impairment Scale
Functional Ambulation Category
Functional Independence Measure - motor items
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Experimental group
Dynamic sitting exercise to anteroposterior and mediolateral direction with delayed visual feedback
(30 times for each direction per session, 5 sessions a week)
Interventions/Control_2
Control group
Dynamic sitting exercise to anteroposterior and mediolateral direction with conventional visual feedback
(30 times for each direction per session, 5 sessions a 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
-within 30 days from onset
-over 20 years old
-able to perform the task
-able to sit without upper limb support
-able to understand the instruction contents
-no problem for visual or visuospatial perception
-no previous history of neurological diseases other than stroke
-no orthopedic disease influenced on measurement or intervention
-signed informed consent
Key exclusion criteria
none
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Masahide |
| Middle name | |
| Last name | Inoue |
Organization
Saitama medical university international medical center
Division name
Rehabilitation center
Zip code
350-1298
Address
1397-1, Yamane, Hidaka city, Saitama
TEL
042-984-4367
mm0678@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Masahide |
| Middle name | |
| Last name | Inoue |
Organization
Saitama medical university international medical center
Division name
Rehabilitation center
Zip code
350-1298
Address
1397-1, Yamane, Hidaka city, Saitama
TEL
042-984-4367
Homepage URL
mm0678@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
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama medical university international medical center clinical research IRB
Address
1397-1, Yamane, Hidaka city, Saitama
Tel
042-984-4523
chikens@saitama-med.ac.jp
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
| 2020 | Year | 06 | Month | 26 | 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
27
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
Main results already published
Date of protocol fixation
| 2020 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 08 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 25 | Day |
Last modified on
| 2022 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046703
