UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009693 |
|---|---|
| Receipt number | R000011365 |
| Scientific Title | The gait assist method for Parkinson's disease patients using mutual synchronization between movement rhythms |
| Date of disclosure of the study information | 2013/01/05 |
| Last modified on | 2013/01/04 19:20:05 |
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Basic information
Public title
The gait assist method for Parkinson's disease patients using mutual synchronization between movement rhythms
Acronym
The gait assist method for Parkinson's disease patients using mutual synchronization between movement rhythms
Scientific Title
The gait assist method for Parkinson's disease patients using mutual synchronization between movement rhythms
Scientific Title:Acronym
The gait assist method for Parkinson's disease patients using mutual synchronization between movement rhythms
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the influence of interactive rhythmic auditory stimulation on instable locomotion function with Parkinson's disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The amount of change of the time series feature in stride time
Key secondary outcomes
The mean and the variability of stride time
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
The presentation of the interactive rhythmic auditory stimulation during the walk of Parkinson's disease patients
Interventions/Control_2
The presentation of the fixed-tempo rhythmic auditory stimulation during the walk of Parkinson's disease patients
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
| 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 locomotion ability of approximately 200 meters long.
Key exclusion criteria
The Parkinson's disease patients who have serious disorder in hearing or cognitive ability.
Target sample size
24
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
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tokyo Institute of Technology
Division name
Dept. of Computational Intelligence and Systems Science
Zip code
Address
TEL
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
None
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 | 01 | Month | 05 | 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
| 2011 | Year | 10 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 07 | Day |
Date of closure to data entry
| 2012 | Year | 12 | Month | 17 | Day |
Date trial data considered complete
| 2012 | Year | 12 | Month | 27 | Day |
Date analysis concluded
| 2013 | Year | 01 | Month | 04 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 01 | Month | 04 | Day |
Last modified on
| 2013 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011365
