UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057305 |
|---|---|
| Receipt number | R000065507 |
| Scientific Title | Development and Evaluation of Postural Modification Wear for Hemiplegics with Stroke Using Elastic Band |
| Date of disclosure of the study information | 2025/03/17 |
| Last modified on | 2026/03/20 13:02:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Development and Evaluation of Postural Modification Wear for Hemiplegics with Stroke Using Elastic Band
Acronym
Development and Evaluation of Postural Modification Wear for Hemiplegics with Stroke
Scientific Title
Development and Evaluation of Postural Modification Wear for Hemiplegics with Stroke Using Elastic Band
Scientific Title:Acronym
Development and Evaluation of Postural Modification Wear for Hemiplegics with Stroke
Region
| Japan |
Condition
Condition
Stroke paralysis
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to develop and experimentally evaluate the effectiveness of a postural correction wear that can provide feedback while correcting the pelvis and trunk of hemiplegics.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Joint angles, center of gravity, and time-distance factors of gait as measured by motion capture
Key secondary outcomes
Kinematics and kinematic data measured by motion capture and muscle activity using electromyography
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Normal Walking Without Any posture correction wear
Interventions/Control_2
Walking with posture correction wear TypeA
Interventions/Control_3
Walking with posture correction wear TypeB
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria for hemiplegics were: unilateral hemiplegia, no obvious ataxic symptoms, the ability to walk more than 30 meters on their own regardless of their walking style, and consent to participate in the study.
Key exclusion criteria
Exclusion criteria include patients with serious cardiovascular disease, impaired cognitive function or language comprehension, and orthopedic conditions such as severe osteoarthritis.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Junji |
| Middle name | |
| Last name | Katsuhira |
Organization
Toyo University
Division name
Faculty of Design for Welfare Society
Zip code
115-8650
Address
Akabanedai1-7-11, Kitaku, Tokyo
TEL
03-5924-2267
katsuhira@toyo.jp
Public contact
Name of contact person
| 1st name | Junji |
| Middle name | |
| Last name | Katsuhira |
Organization
Toyo University
Division name
Faculty of Design for Welfare Society
Zip code
115-8650
Address
Akabanedai1-7-11, Kitaku, Tokyo
TEL
0359242267
Homepage URL
katsuhira@toyo.jp
Sponsor or person
Institute
Toyo University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT), Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toyo University
Address
Akabanedai1-7-11, Kitaku, Tokyo
Tel
03-5924-2148
ml-akj@toyo.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
| 2025 | Year | 03 | Month | 17 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 18 | 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
| 2025 | Year | 03 | Month | 16 | Day |
Last modified on
| 2026 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065507
