UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057286 |
|---|---|
| Receipt number | R000065485 |
| Scientific Title | Lower limb control mechanisms during walking with elastic walking aids. |
| Date of disclosure of the study information | 2025/03/14 |
| Last modified on | 2025/03/14 13:46:42 |
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Basic information
Public title
Lower limb control mechanisms during walking with elastic walking aids.
Acronym
Gait analysis in walking aids
Scientific Title
Lower limb control mechanisms during walking with elastic walking aids.
Scientific Title:Acronym
Gait analysis in walking aids
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the lower limb control mechanism during walking with an elastic walking aid.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Three-dimensional motion analysis data of the body while walking with the orthosis (comparison before and after wearing the orthosis)
Key secondary outcomes
Lower limb joint moment
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Walking with elastic walking aids
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
No history of orthopedic or central nervous system disease
Key exclusion criteria
Persons with a history of orthopedic and central nervous system diseases
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Toshio |
| Middle name | |
| Last name | Soma |
Organization
Niigata university of health and welfare
Division name
Faculty of Rehabilitation
Zip code
950-3198
Address
1398 shimami-cho kita-ku niigata, Japan
TEL
025-257-4730
soma@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Toshio |
| Middle name | |
| Last name | Soma |
Organization
Niigata university of health and welfare
Division name
Faculty of Rehabilitation
Zip code
950-3198
Address
1398 shimami-cho kita-ku niigata, Japan
TEL
025-257-4730
Homepage URL
soma@nuhw.ac.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata university of health and welfare
Address
1398 shimami-cho kita-ku niigata, Japan
Tel
025-257-4730
soma@nuhw.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
| 2025 | Year | 03 | Month | 14 | 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
| 2025 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | 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
| 2025 | Year | 03 | Month | 14 | Day |
Last modified on
| 2025 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065485
