UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of usability of activity assistive devices in simulated home environment
Acronym	Usability of activity assistive devices
Scientific Title	Investigation of usability of activity assistive devices in simulated home environment
Scientific Title:Acronym	Usability of activity assistive devices
Region	Japan

Condition
Condition	Healthy person and patients with central nervous system disorders
Classification by specialty	Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Consider the efficiency of newly developed activity assist devices for home use.
Basic objectives2	Others
Basic objectives -Others	Usability
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Questionnaire poll
Key secondary outcomes	Device usage log Kinematic data (incl. 3D motion analysis, muscle activity) Kinetic data (incl. floor reaction force, seat pressure distribution) Vital sign (incl. heart rate, blood pressure, SpO2).

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	Treatment
Type of intervention	Other
Interventions/Control_1	Learning the way to use activity assistive devices and practical usage Experience of tele-exercise by the Internet-connected computer
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	1. Participants who have understood the study procedures and aims and given written informed consent by themselves after receiving a detailed explanation of the study. 2. In the case of a long-term care or an outpatient, those who live at home independently or under the support of one caregiver. 3. In the case of an inpatient, a patient who sets or prospects to discharge to home.
Key exclusion criteria	1. Whole body condition is unstable. 2. A lack of understanding of instruction and device operation by cognitive decline, aphasia and others. 3. Dysphagia during treatment. 4. Other symptoms as inappropriate judged by the research director.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Yohei Middle name Last name Otaka
Organization	Fujita Health University, School of Medicine
Division name	Department of Rehabilitation Medicine I
Zip code	470-1192
Address	1-98, Dengakugakubo, Kutsukake, Toyoake, Aichi, Japan
TEL	0562-93-2167
Email	rehabmed@fujita-hu.ac.jp

Public contact
Name of contact person	1st name Hikaru Middle name Last name Kondo
Organization	Fujita Health University
Division name	Department of Rehabilitation Medicine I, School of Medicine
Zip code	470-1192
Address	1-98, Dengakugakubo, Kutsukake, Toyoake, Aichi, Japan
TEL	0562-93-9720
Homepage URL
Email	khikaru@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University
Institute
Department

Funding Source
Organization	Aichi Science & Technology Foundation: Aichi Synchrotron Radiation Center, Knowledge Hub Aichi Priority Research Project
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Medical Research IRB, Center for research promotion and support, Fujita Health University
Address	1-98, Dengakugakubo, Kutsukake, Toyoake, Aichi, Japan
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	藤田医科大学（愛知県） 藤田医科大学病院（愛知県）

Other administrative information
Date of disclosure of the study information	2018 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially published

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	2018 Year 04 Month 01 Day
Date of IRB	2018 Year 01 Month 19 Day
Anticipated trial start date	2018 Year 04 Month 10 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	2018 Year 10 Month 29 Day
Last modified on	2021 Year 04 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039550