UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037458 |
|---|---|
| Receipt number | R000042704 |
| Scientific Title | Development of foot orthosis for walking hemiplegic patients and gait analysis evaluation |
| Date of disclosure of the study information | 2019/07/24 |
| Last modified on | 2022/01/24 09:39:43 |
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Basic information
Public title
Development of foot orthosis for walking hemiplegic patients and gait analysis evaluation
Acronym
Development of foot orthosis and gait analysis
Scientific Title
Development of foot orthosis for walking hemiplegic patients and gait analysis evaluation
Scientific Title:Acronym
gait analysis
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this research is to develop a carbon brace and to evaluate it by gait analysis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1) Lower leg joint angle change during walking
(2) Lower limb joint moment while walking
(3) Percentage of walking cycle (percentage of load response period, percentage of mid-stance phase, percentage of late standing phase, percentage of previous swing phase)
(4) Walking speed
(5) Step length
(6) The pace
Key secondary outcomes
(1) Lower limbs Brunstrom stage
(2) MAS (test of muscle tone)
(3) Motion range of lower extremity joints (ankle base flexion, knee flexion, hip flexion)
(4) MMT (hand strength test)
(5) Height
(6) Weight
(7) Age
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Single group test
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
| 89 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Stroke hemiplegia who use short-limb orthosis in daily life
Key exclusion criteria
Stroke hemiplegic person who does not use short-limb orthosis in everyday life
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Kon |
Organization
Hokkaido University of Science
Division name
Department of Prosthetics and Orthotics
Zip code
006-0818
Address
4-1, 15 Chome Hachijo Maeda Te Ina Ward Sapporo City Hokkaido
TEL
0116882240
keisukekonn@gmail.com
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Kon |
Organization
Hokkaido University of Science
Division name
Department of Prosthetics and Orthotics
Zip code
0068585
Address
4-1, 15 Chome Hachijo Maeda Te Ina Ward Sapporo City Hokkaido
TEL
0116882240
Homepage URL
keisukekonn@gmail.com
Sponsor or person
Institute
Hokkaido University of Science
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University of Science Entrance Examination, Region Promotion Department Research Promotion Division
Address
4-1, 15 Chome Hachijo Maeda Te Ina Ward Sapporo City Hokkaido
Tel
011-688-2241
kenkyu@hus.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
| 2019 | Year | 07 | Month | 24 | 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
10
Results
The ratio of the terminal stance phase increased due to wearing the brace.
Results date posted
| 2020 | Year | 07 | Month | 21 | Day |
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | 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
| 2019 | Year | 07 | Month | 23 | Day |
Last modified on
| 2022 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042704
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
