UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056198 |
|---|---|
| Receipt number | R000064213 |
| Scientific Title | The effects of an articulated ankle-foot orthosis with resistance-adjustable joints on muscle activity during gait in healthy young adults |
| Date of disclosure of the study information | 2024/11/20 |
| Last modified on | 2024/11/19 17:25:47 |
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Basic information
Public title
The effects of an articulated ankle-foot orthosis with resistance-adjustable joints on muscle activity during gait in healthy young adults
Acronym
Gait analysis using an ankle-foot- orthosis
Scientific Title
The effects of an articulated ankle-foot orthosis with resistance-adjustable joints on muscle activity during gait in healthy young adults
Scientific Title:Acronym
Gait analysis using an ankle-foot- orthosis
Region
| Japan |
Condition
Condition
healthy young adults
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the current study is to investigate the effects of incremental changes in plantarflexion resistance of an AFO on muscle activity of lower limb while waking in healthy young adults.
Basic objectives2
Others
Basic objectives -Others
The aim of the current study is to investigate the effects of incremental changes in dorsiflexion resistance of an AFO on muscle activity of lower limb while waking in healthy young adults.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
muscle activity in the lower limb
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Adjustment of dorsiflexion and plantarflexion resistance for an ankle-foot orthosis
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
| 18 | years-old | <= |
Age-upper limit
| 25 | years-old | >= |
Gender
Male
Key inclusion criteria
subject who have given consent for the study
Key exclusion criteria
Subjects who have any musculoskeletal issues, cognitive problems, or confounding injuries limiting their
walking ability are excluded from this study.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Soji |
| Middle name | |
| Last name | Tanaka |
Organization
Niigata University of Health and Welfare
Division name
Faculty of Rehabilitation, Dept. of Prosthetics, Orthotics and Assistive Technology
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigatacity, Niigata, Japan
TEL
025-257-4579
soji-tanaka@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Soji |
| Middle name | |
| Last name | Tanaka |
Organization
Niigata University of Health and Welfare
Division name
Faculty of Rehabilitation, Dept. of Prosthetics, Orthotics and Assistive Technology
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigatacity, Niigata, Japan
TEL
025-257-4579
Homepage URL
soji-tanaka@nuhw.ac.jp
Sponsor or person
Institute
Soji Tanaka
Niigata University of Health and Welfare
Faculty of Rehabilitation, Dept. of Prosthetics, Orthotics and Assistive Technology
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
Niigata University of Health and Welfare, ethics committee
Address
1398 Shimami-cho, Kita-ku, Niigatacity, Niigata, Japan
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 | 20 | 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
| 2024 | Year | 11 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 11 | Month | 19 | Day |
Last follow-up date
| 2026 | 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
| 2024 | Year | 11 | Month | 19 | Day |
Last modified on
| 2024 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064213
