UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012591 |
|---|---|
| Receipt number | R000014728 |
| Scientific Title | The clinical application study of gait assist system based on the mutual synchronization of movement rhythms in the festinating gait of Parkinson's disease |
| Date of disclosure of the study information | 2013/12/17 |
| Last modified on | 2015/06/14 10:09:08 |
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Basic information
Public title
The clinical application study of gait assist system based on the mutual synchronization of movement rhythms in the festinating gait of Parkinson's disease
Acronym
The gait assist system for the festinating gait of Parkinson's disease
Scientific Title
The clinical application study of gait assist system based on the mutual synchronization of movement rhythms in the festinating gait of Parkinson's disease
Scientific Title:Acronym
The gait assist system for the festinating gait of Parkinson's disease
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of interactive rhythmic cue on gait disorder with Parkinson's disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The time series characteristics of stride interval
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
The walk of Parkinson's disease patients with the interactive rhythmic cue
Interventions/Control_2
The normal walk of Parkinson's disease patients without any cue before presenting the interactive rhythmic cue
Interventions/Control_3
The normal walk of Parkinson's disease patients without any cue after presenting the interactive rhythmic cue
Interventions/Control_4
The normal walk of healthy experimental subjects without any cue
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The Parkinson's disease patients who have normal hearing and 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 in hearing or cognitive ability or have no symptom of festinating gait as one of the gait disorders with Parkinson's disease.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Miyake |
Organization
Tokyo Institute of Technology
Division name
Dept. of Computational Intelligence and Systems Science
Zip code
Address
4259 Nagatsuta, Midori, Yokohama 226-8502 Japan
TEL
045-924-5656
miyake@dis.titech.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Miyake |
Organization
Tokyo Institute of Technology
Division name
Dept. of Computational Intelligence and Systems Science
Zip code
Address
4259 Nagatsuta, Midori, Yokohama 226-8502 Japan
TEL
045-924-5656
Homepage URL
miyake@dis.titech.ac.jp
Sponsor or person
Institute
Tokyo Institute of Technology, Dept. of Computational Intelligence and Systems Science
Institute
Department
Personal name
Funding Source
Organization
Tokyo Institute of Technology, Dept. of Computational Intelligence and Systems Science
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
| 2013 | Year | 12 | 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
Completed
Date of protocol fixation
| 2013 | Year | 12 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 19 | Day |
Last follow-up date
| 2014 | Year | 06 | Month | 12 | Day |
Date of closure to data entry
| 2014 | Year | 06 | Month | 12 | Day |
Date trial data considered complete
| 2014 | Year | 06 | Month | 12 | Day |
Date analysis concluded
| 2014 | Year | 06 | Month | 12 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 16 | Day |
Last modified on
| 2015 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014728
| 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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