UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048148 |
|---|---|
| Receipt number | R000054869 |
| Scientific Title | Effects of visual and auditory cues on forward gait instability in patients with Parkinson's disease with freezing of gait |
| Date of disclosure of the study information | 2022/07/13 |
| Last modified on | 2023/06/24 21:32:44 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of visual and auditory cues on forward gait instability in patients with Parkinson's disease with freezing of gait
Acronym
Effects of cues on forward gait instability in patients with Parkinson's disease with freezing of gait
Scientific Title
Effects of visual and auditory cues on forward gait instability in patients with Parkinson's disease with freezing of gait
Scientific Title:Acronym
Effects of cues on forward gait instability in patients with Parkinson's disease with freezing of gait
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verification the effect of external cue on forward gait instability in patients with Parkinson's disease with freezing of gait
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Spatiotemporal gait parameters
Kinematic parameters
Gait stability parameters(distance between center of mass-base of support, margin of stability)
Key secondary outcomes
Hoehn and Yahr stage
New freezing of gait questionnaire
Freezing of gait ratio
Movement Disorders Society-sponsored revision of the Unified Parkinson's Disease Rating Scale
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Perform walking tasks under the following conditions and measure the gait parameters .
1.Normal walking
2.Visual cue
3.Auditory cue (normal rhythm)
4.Auditory cue (slow rhythm)
5.Auditory cue (fast rhythm)
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
1.idiopathic clinically established Parkinson's disease based on the International Parkinson and Movement Disorder Society clinical diagnostic criteria
2.Able to ambulate more than 10 m without the use of a walking aid
Key exclusion criteria
1.no visual or auditory disorders
2.no muscular or neurological disorders that could disturb ambulation
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hideyuki |
| Middle name | |
| Last name | Urakami |
Organization
Osaka Medical and Pharmaceutical University Hospital
Division name
Department of Rehabilitation
Zip code
569-8686
Address
2-7,Daigakumachi,Takatsuki,Osaka 569-8686, Japan
TEL
072-683-1221
hideyuki.urakami@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Hideyuki |
| Middle name | |
| Last name | Urakami |
Organization
Osaka Medical and Pharmaceutical University Hospital
Division name
Department of Rehabilitation
Zip code
569-8686
Address
2-7,Daigakumachi,Takatsuki,Osaka 569-8686, Japan
TEL
072-683-1221
Homepage URL
hideyuki.urakami@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical and Pharmaceutical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committee at Osaka Medical and Pharmaceutical University
Address
2-7,Daigakumachi,Takatsuki,Osaka 569-8686, Japan
Tel
072-683-1221
rinri@ompu.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
大阪医科薬科大学病院（大阪府）、畿央大学（奈良県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 13 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 07 | Month | 13 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 13 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 23 | Day |
Last modified on
| 2023 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054869
