UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055730 |
|---|---|
| Receipt number | R000063690 |
| Scientific Title | Examination of the association between post-stroke association response and movement impairment. |
| Date of disclosure of the study information | 2024/10/03 |
| Last modified on | 2024/10/03 17:42:52 |
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Basic information
Public title
Examination of the association between post-stroke association response and movement impairment.
Acronym
Examination of the association between post-stroke association response and movement impairment.
Scientific Title
Examination of the association between post-stroke association response and movement impairment.
Scientific Title:Acronym
Examination of the association between post-stroke association response and movement impairment.
Region
| Japan |
Condition
Condition
People with post-stroke hemiplegia
Classification by specialty
| Geriatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a new evaluation method that can accurately assess the pathophysiology of association reactions and to investigate the relationship between the pathophysiology and movement disorders from a neurophysiological evaluation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1 ARAS 2 FMA 3 5 stand up, 10m walk, BBS 4 MAS 5 NIHSS/mRS 6 Basic information (height, weight, age, months since onset, presence of muscle relaxants or botulinum injection)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inpatients and users of related facilities
Key exclusion criteria
1) Those who refused to participate in this study. 2) Those who had significant visual or hearing impairment. 3) Those who need acute medical management. 4) Those who are in the terminal stage or receiving palliative care. 5) Those whose native language is not Japanese. 6) Those who have difficulty completing the questionnaire due to cognitive impairment such as dementia or higher brain dysfunction.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Jikko |
Organization
Medical Corporation Jusankai Nursing and Health Care Facility for the Elderly, Vanbert
Division name
Corporate Rehabilitation Department Juntendo University Graduate School of Medicine Ph.
Zip code
5780941
Address
2-8, Iwatamachi 4-chome, Higashiosaka-shi, Osaka
TEL
0729616888
jicchi.08p021@gmail.com
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | Iki |
Organization
Kawaguchi Neurosurgical Rehabilitation Clinic
Division name
Department of Rehabilitation
Zip code
5730086
Address
9-25-202 Koroen-cho, Hirakata-shi, Osaka-fu
TEL
0728351010
Homepage URL
kawaguchi.ns.reha@gmail.com
Sponsor or person
Institute
Kawaguchi Neurosurgical Rehabilitation Clinic
Institute
Department
Personal name
Funding Source
Organization
Kawaguchi Neurosurgical Rehabilitation Clinic
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
Kawaguchi Neurosurgical Rehabilitation Clinic
Address
9-25-202 Koroen-cho, Hirakata-shi, Osaka-fu
Tel
0728351010
kawaguchi.ns.reha@gmail.com
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
| 2024 | Year | 10 | 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
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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 11 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1 ARAS 2 FMA 3 5 stand up, 10m walk, BBS 4 MAS 5 NIHSS/mRS 6 Basic information (height, weight, age, months since onset, presence of muscle relaxants or botulinum injection)
Management information
Registered date
| 2024 | Year | 10 | Month | 03 | Day |
Last modified on
| 2024 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063690
