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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000037458
Receipt No. 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 2020/07/21

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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
Email 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
Email keisukekonn@gmail.com

Sponsor
Institute Hokkaido University of Science
Institute
Department

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 0116882240
Email keisukekonn@gmail.com

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
2020 Year 07 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042704

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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