UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037754 |
|---|---|
| Receipt number | R000043057 |
| Scientific Title | Efficacy of insole on the treatment of neurological diseases |
| Date of disclosure of the study information | 2019/08/21 |
| Last modified on | 2021/09/01 10:34:06 |
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Basic information
Public title
Efficacy of insole on the treatment of neurological diseases
Acronym
Efficacy of insole on the treatment of neurological diseases
Scientific Title
Efficacy of insole on the treatment of neurological diseases
Scientific Title:Acronym
Efficacy of insole on the treatment of neurological diseases
Region
| Japan |
Condition
Condition
parkinson disease, Parkinsonism, brain infarction
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy of insole on the motor dysfunction of neurological diseases
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Various walking parameters (e.g. 3-dimentional motion analysis and questionnaire)
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
The condition that the insole is not worn.
The condition that the insole is worn.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with Parkinson desease, Parkinsonism and brain infarction.
Subject who come under all the following (1) and (2).
(1) Subject who can walk by alone or using walking aid.
(2) Subject who understands the purpose of this study and various instructions on this study and can informed consent for participation.
Key exclusion criteria
Subject who come under to any of the following (1) to (3).
(1) Subject who can not understands the purpose of this study and various instructions on this study and can not informed consent for participation.
(2) If it is difficult to wear the HONDA Walking Assistive Device.
(3) Subject who are judged as inappropriate to be enrolled in this study by principal investigator or member of this study project.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Hasegawa |
Organization
Prefectural University of Hiroshima
Division name
Faculty of Health and Welfare
Zip code
723-0053
Address
1-1 Gakuen-cho, Mihara-shi, Hiroshima 723-0053, Japan
TEL
0848-60-1230
m-hasegawa@pu-hiroshima.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Hasegawa |
Organization
Prefectural University of Hiroshima
Division name
Faculty of Health and Welfare
Zip code
723-0053
Address
Gakuen-cho, Mihara-shi, Hiroshima 723-0053, Japan
TEL
0848-60-1230
Homepage URL
m-hasegawa@pu-hiroshima.ac.jp
Sponsor or person
Institute
Prefectural University of Hiroshima
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
Prefectural University of Hiroshima
Address
1-1 Gakuencho, Mihara city Hiroshima
Tel
0848-60-1230
m-hasegawa@pu-hiroshima.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 | 08 | Month | 21 | 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
Suspended
Date of protocol fixation
| 2019 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2022 | 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
| 2019 | Year | 08 | Month | 21 | Day |
Last modified on
| 2021 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043057
| Research Plan | |
|---|---|
| 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 |
