UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047370 |
|---|---|
| Receipt number | R000054031 |
| Scientific Title | Walking analysis of carbon fiber ENAPLE ankle foot orthosis |
| Date of disclosure of the study information | 2022/05/01 |
| Last modified on | 2022/04/02 15:37:44 |
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Basic information
Public title
Walking analysis of carbon fiber ENAPLE ankle foot orthosis
Acronym
Walking analysis of carbon fiber ENAPLE ankle foot orthosis
Scientific Title
Walking analysis of carbon fiber ENAPLE ankle foot orthosis
Scientific Title:Acronym
Walking analysis of carbon fiber ENAPLE ankle foot orthosis
Region
| Japan |
Condition
Condition
Healthy adult
Disabled athletes
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Walking analysis of ankle foot orthotic devices with different materials
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
plastic AFO
ENAPLE AFO
joint angle
center of gravity
joint torque
walking speed
cadence
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
No orthosis
Interventions/Control_2
ENPLE AFO
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
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adult
Disabled athletes
Free will consent
Key exclusion criteria
Those whose measurement task may affect
their physical condition.
Those whose measurement task may affect their physical condition.
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | isao |
| Middle name | |
| Last name | ojima |
Organization
Faculty of Rehabilitation,
Kobe gakuin university
Division name
department of physical therapy
Zip code
6512180
Address
518 arise, ikawadani-cho, nishi-ku Kobe, 651-2180
TEL
078-974-2198
ojima@reha.kobegakuin.ac.jp
Public contact
Name of contact person
| 1st name | isao |
| Middle name | |
| Last name | ojima |
Organization
Kobe gakuin university
Division name
faculty of rehabilitation
Zip code
651-2276
Address
518 arise, ikawadani-cho, nishi-ku Kobe, 651-2180
TEL
09087563844
Homepage URL
ojima@reha.kobegakuin.ac.jp
Sponsor or person
Institute
kobe gakuin university
Institute
Department
Personal name
Funding Source
Organization
kobe gakuin university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Sawamura Prosthesis Mfg. Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
kobe gakuin university
Address
518 arise, ikawadani-cho, nishi-ku Kobe, 651-2180
Tel
0789742198
ojima@reha.kobegakuin.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
| 2022 | Year | 05 | Month | 01 | 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 | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2023 | 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 | 02 | Day |
Last modified on
| 2022 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054031
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
