UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050951 |
|---|---|
| Receipt number | R000057912 |
| Scientific Title | Exploration study for the feasibility and acceptability of video-based rehabilitation in community-dwelling adults with stroke |
| Date of disclosure of the study information | 2023/04/28 |
| Last modified on | 2023/04/28 12:18:01 |
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Basic information
Public title
Exploration study for the feasibility and acceptability of video-based rehabilitation in community-dwelling adults with stroke
Acronym
Exploration study for the feasibility and acceptability of video-based rehabilitation in community-dwelling adults with stroke
Scientific Title
Exploration study for the feasibility and acceptability of video-based rehabilitation in community-dwelling adults with stroke
Scientific Title:Acronym
Exploration study for the feasibility and acceptability of video-based rehabilitation in community-dwelling adults with stroke
Region
| Japan |
Condition
Condition
Community-dwelling adults with stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purposes of this study are to preliminaly investigate the effects of video-based rehabilitation and to explore the feasibility and acceptability of video-based rehabilitation in community-dwelling adults with stroke.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
System Usability Scale
Key secondary outcomes
Body Awareness Scale, Reach test, Subjective evaluation, compliance, adverse event
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Video-based rehabilitation
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Community-dwelling adults with stroke
20-85 years old at the time consent is obtained
modified Rankin Scale 1-3
Stroke survivors who undertake home-based rehabilitation at least once a week
Key exclusion criteria
Difficulty in operating a computer or understanding the content of an exercise due to cognitive dysfunction
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Hasegawa |
Organization
Prefectural University of Hiroshima
Division name
Department of Physical Therapy, Faculty of Health and Welfare
Zip code
723-0053
Address
1-1 Gakuen-cho, Mihara-shi, Hiroshima, Japan
TEL
0848-60-1225
m-hasegawa@pu-hiroshima.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Imura |
Organization
Hiroshima Cosmopolitan University
Division name
Department of Rehabilitation
Zip code
731-3166
Address
1-2-3, Otsuka-higashi, Asaminami-ku, Hiroshima
TEL
0828496883
Homepage URL
imura@hcu.ac.jp
Sponsor or person
Institute
Prefectural University of Hiroshima
Institute
Department
Personal name
Funding Source
Organization
ReMotto Inc.
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
the ethical committee of the Prefectural University of Hiroshima
Address
1-1 Gakuen-cho, Mihara-shi, Hiroshima, Japan
Tel
0848-60-1225
m-hasegawa@pu-hiroshima.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
| 2023 | Year | 04 | Month | 28 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 03 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 04 | Month | 28 | Day |
Last modified on
| 2023 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057912
