UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056364 |
|---|---|
| Receipt number | R000064382 |
| Scientific Title | Development of an evaluation method for success or failure of gait using a safety suspension system and clinical application |
| Date of disclosure of the study information | 2024/12/06 |
| Last modified on | 2025/09/14 16:29:19 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Development of an evaluation method for success or failure of gait using a safety suspension system and clinical application
Acronym
Development of an evaluation method for success or failure of gait using a safety suspension system and clinical application
Scientific Title
Development of an evaluation method for success or failure of gait using a safety suspension system and clinical application
Scientific Title:Acronym
Development of an evaluation method for success or failure of gait using a safety suspension system and clinical application
Region
| Japan |
Condition
Condition
Healthy individuals
Patients for rehabilitation
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To Develop of an evaluation method for success or failure of gait using a safety suspension system
Basic objectives2
Others
Basic objectives -Others
Development
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tension values obtained from sensors installed on safety suspension systems
Key secondary outcomes
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Walking at a comfortable speed of 20m
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy individuals
1.Consent to participate in this study
2.Healthy people aged 20 to 70
Patients for rehabilitation
1.Consent to participate in this study
2.Patients aged 20 to 85
3.Patients who can walk 20 meters, but still need the assistance of a therapist due to occasional stumbling and tripping
4.Patients who understand the task and can follow instructions
Key exclusion criteria
Healthy individuals
1.history of diseases that may affect this study
2.Pregnant women and those who may be pregnant
Patients for rehabilitation
1.Patients who have difficulty understanding instructions
2.Pregnant women and those who may be pregnant
3.Patients who need to be isolated due to infectious diseases
4.Patients who are judged to be inappropriate by the researcher
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Otaka |
Organization
Fujita Health University
Division name
Department of Rehabilitation Medicine, School of Medicine
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
0562-93-2167
rehabmed@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Kato |
Organization
Fujita Health University hospital
Division name
Department of Rehabilitation
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
0562-93-9752
Homepage URL
kato04111871@gmail.com
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
none
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
Ethics Review Committee of Fujita Health University
Address
1-98, Dengakugakubo, Kutsukake-cho, 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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 23 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
October 2, 2022: First Edition Created; Implementation Permitted March 23, 2023
July 18, 2025: Second Edition Created; Implementation Permitted September 4, 2025
Management information
Registered date
| 2024 | Year | 12 | Month | 05 | Day |
Last modified on
| 2025 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064382
