UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056089 |
|---|---|
| Receipt number | R000063819 |
| Scientific Title | Investigation of neural mechanism of impeding gait training and effect of ankle-foot-orthosis |
| Date of disclosure of the study information | 2024/11/15 |
| Last modified on | 2025/03/03 10:54:09 |
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Basic information
Public title
Investigation of neural mechanism of impeding gait training and effect of ankle-foot-orthosis
Acronym
Investigation of neural mechanism of impeding gait training
Scientific Title
Investigation of neural mechanism of impeding gait training and effect of ankle-foot-orthosis
Scientific Title:Acronym
Investigation of neural mechanism of impeding gait training
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the neural mechanism of impeding gait training and effect of ankle-foot-orthosis
Basic objectives2
Others
Basic objectives -Others
To investigate the neural mechanism of impeding gait training and effect of ankle-foot-orthosis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Electromyographical parameters, Gait parameters, Neurophysiological parameters
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Normal gait
Interventions/Control_2
Solid ankle-foot-orthosis gait
Interventions/Control_3
Articulated ankle-foot-orthosis gait
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
| 18 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Right-hand and leg dominant
Understand the instructions
Key exclusion criteria
Present or history of orthopedic and neurological disorders
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Ryosuke |
| Middle name | |
| Last name | Kitatani |
Organization
Niigata University of Health and Welfare
Division name
Institute for Human Movement and Medical Sciences
Zip code
950-3198
Address
1398, Shimami-cho, Kita-ku, Niigata, Niigata
TEL
025-257-4732
ryosuke-kitatani@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Ryosuke |
| Middle name | |
| Last name | Kitatani |
Organization
Niigata University of Health and Welfare
Division name
Institute for Human Movement and Medical Sciences
Zip code
950-3198
Address
1398, Shimami-cho, Kita-ku, Niigata, Niigata
TEL
025-257-4732
Homepage URL
ryosuke-kitatani@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
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
Ethics Committee, Niigata University of Health and Welfare
Address
Shimami-cho, Kita-ku, Niigata, Niigata
Tel
025-257-4455
rinri@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
| 2024 | Year | 11 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 07 | Day |
Last modified on
| 2025 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063819
