UMIN-CTR Clinical Trial

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
Email	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
Email	mmukaino@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054849