UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048127 |
|---|---|
| Receipt number | R000054849 |
| Scientific Title | Investigation on feasibility of telerehabilitation systems |
| Date of disclosure of the study information | 2022/06/27 |
| Last modified on | 2022/06/21 22:59:31 |
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Basic information
Public title
Investigation on feasibility of telerehabilitation systems
Acronym
Feasibility of telerehabilitation systems
Scientific Title
Investigation on feasibility of telerehabilitation systems
Scientific Title:Acronym
Feasibility of telerehabilitation systems
Region
| Japan |
Condition
Condition
Infectious diseases
Classification by specialty
| Infectious disease | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation on feasibility of telerehabilitation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient satisfaction questionnaire
Key secondary outcomes
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
| Behavior,custom |
Interventions/Control_1
Exercise program with the use of telerehabilitation system
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
1. Those who, after receiving sufficient explanation and with full understanding, have given their free and voluntary written consent to participate in this study
2. Those who are between 20 and 80 years of age.
3. Those who are stable in general condition and independent in daily living
4. Those who have been isolated due to infectious diseases.
Key exclusion criteria
1. Those who are unable to sit in a stable sitting position
2. Those who cannot understand the explanation and cannot handle the tablet PC.
3. Those who are unstable with their vital signs.
4. Those with visual or hearing impairment that makes it difficult to operate the tablet or communicate using it.
5. Those who are deemed inappropriate by the principal investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Otaka |
Organization
Fujita Health University
Division name
Department of rehabilitation medicine I
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake
TEL
0562-93-2167
yootaka@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Masahiko |
| Middle name | |
| Last name | Mukaino |
Organization
Fujita Health University
Division name
Department of rehabilitation medicine I
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake
TEL
0562-93-2167
Homepage URL
mmukaino@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health 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
Fujita Health University Ethics Committee
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake
Tel
0562-93-2865
f-irb@fujita-hu.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
| 2022 | Year | 06 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
32
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
| 2020 | Year | 04 | Month | 16 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 28 | Day |
Last follow-up date
| 2022 | 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
| 2022 | Year | 06 | Month | 21 | Day |
Last modified on
| 2022 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054849
