UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020145 |
|---|---|
| Receipt number | R000023270 |
| Scientific Title | Efficacy validation of walking improvement devices using traction illusion for abnormal gait of Parkinson's disease |
| Date of disclosure of the study information | 2015/12/16 |
| Last modified on | 2017/06/29 19:41:17 |
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Basic information
Public title
Efficacy validation of walking improvement devices using traction illusion for abnormal gait of Parkinson's disease
Acronym
Efficacy validation of walking improvement device for abnormal gait of Parkinson's disease
Scientific Title
Efficacy validation of walking improvement devices using traction illusion for abnormal gait of Parkinson's disease
Scientific Title:Acronym
Efficacy validation of walking improvement device for abnormal gait of Parkinson's disease
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The verification of the improvement effect by the walking assistance device for gait disturbance of patients with Parkinson's disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement time: intervention immediately before and after
Item: stride, walking speed, cadence
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
10m walking in a state in which to below the knee part, was fitted with a device for presenting the traction illusion
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
| 80 | years-old | >= |
Gender
Male
Key inclusion criteria
The Parkinson's disease patients who have no dementia and have the symptom of festinating gait as one of the gait disorders with Parkinson's disease.
Key exclusion criteria
The Parkinson's disease patients who have serious disorder cognitive ability or have no symptom of festinating gait as one of the gait disorders with Parkinson's disease.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyasu Iwata |
Organization
Waseda univ.
Division name
Dept. of Modern Mechanical Engineering
Zip code
Address
Green Computing System Research Organization 40-603, 27, Waseda-cho, Shinjuku-ku, Tokyo
TEL
03-3203-4427
jubi@waseda.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyasu Iwata |
Organization
Waseda univ.
Division name
Dept. of Modern Mechanical Engineering
Zip code
Address
Green Computing System Research Organization 40-603, 27, Waseda-cho, Shinjuku-ku, Tokyo
TEL
03-3203-4427
Homepage URL
jubi@waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 12 | Month | 16 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 08 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 10 | Day |
Last modified on
| 2017 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023270
