UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034691 |
|---|---|
| Receipt number | R000039550 |
| Scientific Title | Investigation of usability of activity assistive devices in simulated home environment |
| Date of disclosure of the study information | 2018/11/01 |
| Last modified on | 2021/04/04 10:29:14 |
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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
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
khikaru@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039550
