UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044629 |
|---|---|
| Receipt number | R000050115 |
| Scientific Title | Analysis of muscle activity during sitting task with the shoulder orthosis for acute stroke |
| Date of disclosure of the study information | 2021/06/23 |
| Last modified on | 2023/01/06 17:11:04 |
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Basic information
Public title
Analysis of muscle activity during sitting task with the shoulder orthosis for acute stroke
Acronym
Analysis of muscle activity during sitting task with the shoulder orthosis for acute stroke
Scientific Title
Analysis of muscle activity during sitting task with the shoulder orthosis for acute stroke
Scientific Title:Acronym
Analysis of muscle activity during sitting task with the shoulder orthosis for acute stroke
Region
| Japan |
Condition
Condition
Stroke with hemiparalysis
Classification by specialty
| Neurology | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study verifies postural alignment and muscle activity before and after wearing the upper limb orthosis using an anterior-posterior comparative test.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
trunk muscle activity during sitting task before and after wearing the upper limb orthosis
Key secondary outcomes
Dynamic sitting balance
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Wear an upper limb orthosis on the paralyzed upper limb and perform a sitting dynamic task.
Interventions/Control_2
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. within 60 days from stroke onset
2. more than 20 years
3. sitting independently
4. stable neurological signs
5. stable general condition
6. There is no range of motion limitation for the shoulder joint
7. able to understand instruction
Key exclusion criteria
Other than those above
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Fukata |
Organization
Saitama Medical University International Medical Center
Division name
Department of rehabilitation center
Zip code
350-1298
Address
1397-1, Yamane, Hidaka, Saitama, Japan
TEL
0429844367
fkazuhiro.68@gmail.com
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Fukata |
Organization
Saitama Medical University International Medical Center
Division name
Department of rehabilitation center
Zip code
350-1298
Address
1397-1, Yamane, Hidaka, Saitama, Japan
TEL
0429844367
Homepage URL
fkazuhiro.68@gmail.com
Sponsor or person
Institute
Saitama Medical University International Medical Center
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University
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
Saitama International University International Medical Center
Address
1397-1, Yamane, Hidaka, Saitama, Japan
Tel
0429844367
imc_irb@saitama-med.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
1
Org. issuing International ID_1
Saitama Medical University International Medical Cent
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 23 | 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
15
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
| 2021 | Year | 01 | Month | 29 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 23 | Day |
Last follow-up date
| 2023 | Year | 03 | 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
| 2021 | Year | 06 | Month | 23 | Day |
Last modified on
| 2023 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050115
