UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043649 |
|---|---|
| Receipt number | R000049836 |
| Scientific Title | A Study of the longitudinal change in Quality of Life (QOL) and the relationship between QOL and physical function or ability of Activities of Daily Living in stroke patients. |
| Date of disclosure of the study information | 2021/03/31 |
| Last modified on | 2021/03/17 17:53:34 |
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Basic information
Public title
A Study of the relationship between Quality of Life and physical function or ability of Activities of Daily Living in stroke patients.
Acronym
The relationship between Quality of Life and physical function or ability of Activities of Daily Living in stroke patients.
Scientific Title
A Study of the longitudinal change in Quality of Life (QOL) and the relationship between QOL and physical function or ability of Activities of Daily Living in stroke patients.
Scientific Title:Acronym
A Study of the longitudinal change in Quality of Life (QOL) and the relationship between QOL and physical function or ability of Activities of Daily Living in stroke patients.
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between Quality of Life and physical function or ability of Activities of Daily Living in stroke patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quality of Life
Key secondary outcomes
Motor function of lower extremity
Gait ability
Ability of Activities of Daily Living
Muscle tonus
ROM
Anxiety/Depression
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
first-ever stroke diagnosed by CT or MRI
Key exclusion criteria
severe cognitive impairment
dementia
depression
malignancy or multiple organ failure
other neuromuscular diseases
serious cardiac, hepatic or renal disease
incomplete answers to the questionnaire
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Watanabe |
Organization
Yamagata Saisei Hospital
Division name
Department of Rehabilitation
Zip code
990-8545
Address
79-1, Okimachi, Yamagata-shi, Yamagata
TEL
023-682-1111
shi.watanabe0827@gmail.com
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Watanabe |
Organization
Yamagata Saisei hospital
Division name
Department of Rehabilitation
Zip code
990-8545
Address
79-1, Okimachi, Yamagata-shi, Yamagata
TEL
023-682-1111
Homepage URL
shi.watanabe0827@gmail.com
Sponsor or person
Institute
Yamagata Saisei hospital
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
Yamagata Saisei hospital IRB
Address
79-1, Okimachi, Yamagata-shi, Yamagata
Tel
023-682-1111
shi.watanabe0827@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
| 2021 | Year | 03 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The relationship between QOL and physical function or ability of Activities of Daily Living in stroke patients.
Management information
Registered date
| 2021 | Year | 03 | Month | 17 | Day |
Last modified on
| 2021 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049836
