UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052720 |
|---|---|
| Receipt number | R000060147 |
| Scientific Title | Verification of the effectiveness of telerehabilitation using an application for epilepsy patients |
| Date of disclosure of the study information | 2023/12/01 |
| Last modified on | 2025/05/09 12:27:26 |
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Basic information
Public title
Verification of the effectiveness of telerehabilitation using an application for epilepsy patients
Acronym
Telerehabilitation using application in epilepsy patients
Scientific Title
Verification of the effectiveness of telerehabilitation using an application for epilepsy patients
Scientific Title:Acronym
Telerehabilitation using application in epilepsy patients
Region
| Japan |
Condition
Condition
epilepsy
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the effectiveness of telerehabilitation for epilepsy patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
EpiTrack (baseline and one month after baseline)
Key secondary outcomes
QOLIE-P-31, NDDI-E, Epilepsy stigma scale
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
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Intervention period: 3 months; Frequency: twice a week; Duration: 30 minutes per session
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
| 18 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Smartphone operation is possible
Key exclusion criteria
History of neurological, psychiatric, or developmental disorders.
Estimate intelligence quotient less than 80.
Post-epilepsy surgery.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Annaka |
Organization
Niigata University of Health and Welfare
Division name
Department of Occupational Therapy
Zip code
950-3102
Address
1398, Shimami-cho, Kita-ku, Niigata
TEL
025-257-4455
hiroki.annaka.n@gmail.com
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Annaka |
Organization
Niigata University of Health and Welfare
Division name
Department of Occupational Therapy
Zip code
950-3102
Address
1398, Shimami-cho, Kita-ku, Niigata
TEL
025-257-4455
Homepage URL
hiroki.annaka.n@gmail.com
Sponsor or person
Institute
Niigata University of Health and Welfare, Department of Occupational Therapy, Hiroki Annaka.
Institute
Department
Personal name
Funding Source
Organization
None
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
Niigata University Health and Welfare
Address
1398 Shimami-chou, Kita-ku, Niigata
Tel
025-257-4437
rinri@nuhw.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 | 12 | Month | 01 | 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 | 08 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 01 | 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
Management information
Registered date
| 2023 | Year | 11 | Month | 07 | Day |
Last modified on
| 2025 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060147
