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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036346
Receipt No. R000041175
Scientific Title Study on the influence of difference in joystick of mobility assist device on usability in healthy young, elderly and patients with central nervous system disorders.
Date of disclosure of the study information 2019/04/01
Last modified on 2021/03/30

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Basic information
Public title Study on the influence of difference in joystick of mobility assist device on usability in healthy young, elderly and patients with central nervous system disorders.
Acronym Study on Joystick usability of mobility assist device.
Scientific Title Study on the influence of difference in joystick of mobility assist device on usability in healthy young, elderly and patients with central nervous system disorders.
Scientific Title:Acronym Study on Joystick usability of mobility assist device.
Region
Japan

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

Objectives
Narrative objectives1 To test whether difference in usability depending on the difference of some joystick types in mobility assistive device.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Subjective operability
Key secondary outcomes Speed, Accuracy, Body function including finger dexterity, Cognitive function, Activities of daily living

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
Device,equipment
Interventions/Control_1 Participants uses some joysticks to drive on a predetermined course, and to reply ease of operation.
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. The subjects who have given written informed consent by themselves.
2. The subjects who can sit independently.
3. The subjects who can transfer between a bed and a wheelchair.
4. The patients with supra-tentorial lesion.
5. The patients with hemiplegia.
6. The patients without apparent paralysis in the unaffected limbs.
Key exclusion criteria 1. The subjects whose general condition was poor.
2. The subjects having difficulties in understanding the study design, providing consent to, or participating in the study due to cognitive impairment, aphasia or dementia.
3. The subjects presenting severe joint deformation including degenerative deformity.
4. The subjects who are decided by a doctor or investigator as being inappropriate for entry into the present study.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Eiichi
Middle name
Last name Saitoh
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 Soichiro
Middle name
Last name Koyama
Organization Fujita Health University, School of Health Sciences
Division name Faculty of Rehabilitation
Zip code 470-1192
Address 1-98, Dengakugakubo, Kutsukake, Toyoake, Aichi, Japan
TEL 0562-93-9000
Homepage URL
Email koyamas@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University
Institute
Department

Funding Source
Organization Fujita Health University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Institutional Review Board of Fujita Health University
Address 1-98 Dengakugakubo, Kutsukake-cho, Toyoake-shi, Aichi
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) Fujita Health University
藤田医科大学病院(愛知県)Fujita Health University Hospital

Other administrative information
Date of disclosure of the study information
2019 Year 04 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
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
2018 Year 02 Month 01 Day
Date of IRB
2018 Year 05 Month 15 Day
Anticipated trial start date
2018 Year 10 Month 01 Day
Last follow-up date
2021 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
2019 Year 03 Month 29 Day
Last modified on
2021 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041175

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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