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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034691
Receipt No. R000039550
Official scientific title of the study Investigation of usability of activity assistive devices in simulated home environment
Date of disclosure of the study information 2018/11/01
Last modified on 2018/10/29

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Basic information
Official scientific title of the study Investigation of usability of activity assistive devices in simulated home environment
Title of the study (Brief title) 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 Eiichi Saitoh
Organization Fujita Health University, School of Medicine
Division name Department of Rehabilitation Medicine I
Address 1-98, Dengakugakubo, Kutsukake, Toyoake, Aichi, Japan
TEL 0562-93-2167
Email rehabmed@fujita-hu.ac.jp

Public contact
Name of contact person Tsuyoshi Tatemoto
Organization Fujita Health University, School of Health Sciences
Division name Faculty of Rehabilitation
Address 1-98, Dengakugakubo, Kutsukake, Toyoake, Aichi, Japan
TEL 0562-93-9000
Homepage URL
Email tatemoto@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)

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

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 04 Month 01 Day
Anticipated trial start date
2018 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 10 Month 29 Day
Last modified on
2018 Year 10 Month 29 Day


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

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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