UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036346 |
|---|---|
| Receipt number | 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 | 2022/07/08 09:03:47 |
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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
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
koyamas@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
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
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
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000041175
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000041175
Number of participants that the trial has enrolled
44
Results
Despite no significant differences in the primary outcome between joysticks, the I-shaped joystick with rounded tips (neutral grip) was ranked higher than the others. MT did not differ between joysticks, but DA was higher for the thin-columnar I-shaped joystick (pinch grip) than for the U- and T-shaped joysticks (pronated grip). MT and DA scores for young adults were significantly better than those for older adults. Further studies should be conducted to clarify possible factors related to EPW operability.
Results date posted
| 2022 | Year | 04 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Forty-four healthy adults (22 young and 22 old).
Participant flow
All patients were enrolled.
Adverse events
No adverse events occurred in this study.
Outcome measures
Subjective ranking
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2022 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041175
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