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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040933
Receipt No. 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 2020/06/28

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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
Email 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
Email sousyo.reha@gmail.com

Sponsor
Institute Remote Physical Therapy Study Group
Institute
Department

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
Email rinri@jiu.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
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
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
2021 Year 11 Month 30 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
2020 Year 06 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046738

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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