UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040933 |
|---|---|
| Receipt number | R000046738 |
| Scientific Title | Effects of remote physical therapy using Information and Communication Technology system for people at day care service: a multicenter, block-randomized, controlled trial |
| Date of disclosure of the study information | 2020/07/01 |
| Last modified on | 2022/07/25 21:11:25 |
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Basic information
Public title
Effects of remote physical therapy using Information and Communication Technology system for people at day care service
Acronym
Remote Physical Therapy Study
Scientific Title
Effects of remote physical therapy using Information and Communication Technology system for people at day care service: a multicenter, block-randomized, controlled trial
Scientific Title:Acronym
Remote Physical Therapy Study
Region
| Japan |
Condition
Condition
People certified for Requiring Support 1 to Long-Term Care 2 who use Commuting for care
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We build the intervention system by physical therapist using Information and Communication Technology (remote ICT system), which is conducted with multicenter, block-randomized, controlled trial. We aimed to investigate the efficacy of remote ICT system on certification of needed long-term care, physical function, physical activity, and medical expenses.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle strength (hand grips strength)
Short Physical Performance Battery
Timed Up & Go Test
physical activity (mean daily steps)
Key secondary outcomes
Tokyo Metropolitan Institute of Gerontology Index of Competence
QOL(EQ-5D-5L)
Medical expenses
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Remote ICT group
Physical therapist evaluates participant's physical function and makes an exercise menu for individual using ICT system on PC or Smartphone. It will be conducted for six months adding to usual care at each day service center.
Interventions/Control_2
Face-to-face group
Physical therapist evaluates participant's physical function and makes an exercise menu for individual face-to-face.
It will be conducted for six months adding to usual care at each day service center.
Interventions/Control_3
Control group
Physical therapist neither evaluate nor advices. Each day service center conducts usual service for six months.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
People certified for Requiring Support 1 to Long-Term Care 2.
People who can perform timed up and go test
People who can perform group exercise at day service center
Key exclusion criteria
People who's cognitive function is impaired to understand for research content.
People who cannot perform exercise menu due to presence of complication
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | nobuhide |
| Middle name | |
| Last name | kawabe |
Organization
Tohto University
Division name
Faculty of Makuhari Human Care
Zip code
261-0021
Address
1-1 HIbino, Mihama-ku, Chiba City, Chiba
TEL
043-273-1111
sousyo.reha@gmail.com
Public contact
Name of contact person
| 1st name | nobuhide |
| Middle name | |
| Last name | kawabe |
Organization
Tohto University
Division name
Faculty of Makuhari Human Care
Zip code
261-0021
Address
1-1 HIbino, Mihama-ku, Chiba City, Chiba
TEL
043-273-1111
Homepage URL
sousyo.reha@gmail.com
Sponsor or person
Institute
Remote Physical Therapy Study Group
Institute
Department
Personal name
Funding Source
Organization
Japan Physical Therapy Association
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
NEC Corporation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Josai International University Institutional Review Board
Address
1 Gumyo, Togane City, Chiba 283-8555, Japan
Tel
0475557832
nobuhide.kawabe@tohto.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
| 2020 | Year | 07 | 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
224
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 09 | Month | 04 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 28 | Day |
Last modified on
| 2022 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046738
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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