UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047447 |
|---|---|
| Receipt number | R000054107 |
| Scientific Title | Development and evaluation of a wearable and controllable orthosis with fall prevention system to support walking |
| Date of disclosure of the study information | 2022/04/10 |
| Last modified on | 2022/04/09 17:47:08 |
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Basic information
Public title
Development and evaluation of a wearable and controllable orthosis with fall prevention system to support walking
Acronym
Development and evaluation of a wearable and controllable orthosis with fall prevention system to support walking
Scientific Title
Development and evaluation of a wearable and controllable orthosis with fall prevention system to support walking
Scientific Title:Acronym
Development and evaluation of a wearable and controllable orthosis with fall prevention system to support walking
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to verify the effect of fall prevention and changes in physical movement during walking using a controllable shoe-type orthosis including a lateral fall prevention system.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Kinematic and kinematic data during gait
Key secondary outcomes
Adverse events when using the orthosis
Electromyography data during gait
Subjective assessments of orthotic comfort and usability
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
Orthosis with real-time controllable lateral fall prevention system
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Have no history of orthopedic conditions of the foot and be able to walk independently.
The applicant must be able to understand the purpose and methods of the study.
The study will be limited to those who have given informed consent.
Key exclusion criteria
Discomfort or pain in the hip, knee or foot area
Contraindications to exercise
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Toshihiko |
| Middle name | |
| Last name | Shiraishi |
Organization
Yokohama National University
Division name
Graduate School of Environment and Information Sciences
Zip code
240-8501
Address
79-7, Tokiwadai, Hodogaya-ku, Yokohama, Kanagawa, 240-8501, Japan
TEL
0453394215
shira@ynu.ac.jp
Public contact
Name of contact person
| 1st name | Rieko |
| Middle name | |
| Last name | Yamamoto |
Organization
Yokohama National University
Division name
Graduate School of Environment and Information Sciences
Zip code
240-8501
Address
79-7, Tokiwadai, Hodogaya-ku, Yokohama, Kanagawa, 240-8501, Japan
TEL
0453394215
Homepage URL
yamamoto-rieko-tz@ynu.jp
Sponsor or person
Institute
Yokohama National University
Institute
Department
Personal name
Funding Source
Organization
Yokohama National University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kitasato University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Initiatives and Promotion Organization, Yokohama National University
Address
79-5 Tokiwadai, Hodogaya-ku, Yokohama, 240-8501, Japan
Tel
0453393075
kenkyu.somu@ynu.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
北里大学（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 04 | Month | 11 | Day |
Last follow-up date
| 2024 | 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
| 2022 | Year | 04 | Month | 09 | Day |
Last modified on
| 2022 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054107
