UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056880 |
|---|---|
| Receipt number | R000065017 |
| Scientific Title | A preliminary study on the effect of the knee orthosis that prevent the knee bending during the stance phase on the walking ability in patients with brain disorders |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/01/31 09:38:59 |
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Basic information
Public title
A preliminary study on the effect of the knee orthosis that prevent the knee bending during the stance phase on the walking ability in patients with brain disorders
Acronym
The effect of the knee orthosis that prevent the knee bending during the stance phase on the walking ability
Scientific Title
A preliminary study on the effect of the knee orthosis that prevent the knee bending during the stance phase on the walking ability in patients with brain disorders
Scientific Title:Acronym
The effect of the knee orthosis that prevent the knee bending during the stance phase on the walking ability
Region
| Japan |
Condition
Condition
Brain disorders
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of the knee orthosis that prevent the knee bending during the stance phase on the walking ability in patients with brain disorders
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficiency of improvement in walking independence
Change in walking speed
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The gait traing using the knee orthosis that prevent the knee bending during the stance phase
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have gait disorders due to first-ever brain disorders
Patients who scored 3 or less on the knee-extension test in the motor function item of the Stroke Impairment Assessment Set
Key exclusion criteria
Unstable vital sign
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Otaka |
Organization
Fujita Health University
Division name
Department of rehabilitation medicine, School of medicine
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, Japan
TEL
0562-93-2167
rehab@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Matsuura |
Organization
Fujita Health University
Division name
Department of Rehabilitation medicine, School of medicine
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, Japan
TEL
0562-93-2167
Homepage URL
rehab@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Toyota motor corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Fujita Health University
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, Japan
Tel
0562-93-2865
f-irb@fujita-hu.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
| 2025 | Year | 04 | 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
| 2024 | Year | 10 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2029 | 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 | 01 | Month | 31 | Day |
Last modified on
| 2025 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065017
