UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046738