UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032088 |
|---|---|
| Receipt number | R000036608 |
| Scientific Title | Effect of lateral wedge for standing balance capacity in patients with acute stroke -a randomized controlled trial - |
| Date of disclosure of the study information | 2018/04/03 |
| Last modified on | 2021/04/09 05:59:03 |
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Basic information
Public title
Effect of lateral wedge for standing balance capacity in patients with acute stroke
-a randomized controlled trial -
Acronym
Effect of lateral wedge for standing balance capacity in patients with acute stroke
-a randomized controlled trial -
Scientific Title
Effect of lateral wedge for standing balance capacity in patients with acute stroke
-a randomized controlled trial -
Scientific Title:Acronym
Effect of lateral wedge for standing balance capacity in patients with acute stroke
-a randomized controlled trial -
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurology | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of lateral wedge for standing balance capacity in patients with acute stroke
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Berg Balance Scale
Key secondary outcomes
Standing balance
Stroke Impairment Assessment Set
Trunk Control Test
Trunk Impairment Scale
Functional Ambulation Category
Functional Independence Measure
Kinematic analysis
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Experimental group
Reach exercise to non-paretic side on the lateral wedge
(30 times per session, 5 sessions a week)
Interventions/Control_2
Control group
Reach exercise to non-paretic side on the horizontal plane
(30 times 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
1)no history of stroke
2)within 30 days from onset
3)supratentorial lesion
4)over 20 years old
5)right handed
6)stable of neurological conditions
7)no respiratory and cardiovascular diseases
8)having a hemiparesis
9)signed informed consent
Key exclusion criteria
1)cannot understand the instruction
2)having mental disease or dementia
3)cannot execute the task due to musculoskeletal disease
4)Bilateral lesions
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahide Inoue |
Organization
Saitama medical university international medical center
Division name
Rehabilitation center
Zip code
Address
1397-1, Yamane, Hidaka city, Saitama
TEL
042-984-4367
mm0678@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahide Inoue |
Organization
Saitama medical university international medical center
Division name
Rehabilitation center
Zip code
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
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
| 2018 | Year | 04 | Month | 03 | 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
52
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
| 2018 | Year | 04 | Month | 03 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 04 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 03 | Day |
Last modified on
| 2021 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036608
