UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027989 |
|---|---|
| Receipt number | R000032053 |
| Scientific Title | Investigation of the effectiveness of metronome pacing on freezing of gait |
| Date of disclosure of the study information | 2017/06/29 |
| Last modified on | 2020/04/03 16:22:07 |
* 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
Investigation of the effectiveness of metronome pacing on freezing of gait
Acronym
Investigation of the effectiveness of metronome pacing on freezing of gait
Scientific Title
Investigation of the effectiveness of metronome pacing on freezing of gait
Scientific Title:Acronym
Investigation of the effectiveness of metronome pacing on freezing of gait
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the effectiveness of metronome on freezing of gait, a leading cause of difficulty in walking in patients with Parkinson's disease, using a three-dimensional motion analyzer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes of bilateral knee angles, stride length, walking speed, acceleration.
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
Patients are requested to stand up from the chair and walk 5 meters, then turn 180 degrees and return to chair with and without the guide sound of the metronome. Patients will repeat this motion for 15 minutes to 20 minutes (including break time) until freezing of gait is elicited.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Patients diagnosed with Parkinson's disease.
2)Patients from 20 to 85 years of age at the time of acquisition of informed consent.
3)Patients who have given written consent on participation of this study.
Key exclusion criteria
1) Patients who are unable to walk on their own or have difficulty understanding instructions.
Patients who have had medical assistance due to fall at least once.
Patients with impaired hearing abilities who have difficulty hearing the sound of metronome.
2) Pregnant or lactating women, or possibly pregnant women.
3) Other patients who are deemed as ineligible for this research by investigators.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirofumi Maruyama |
Organization
Hiroshima University
Division name
Department of Clinical Neuroscience and Therapeutics
Zip code
Address
1-2-3 Kasumi Minamiku Hiroshima-shi
TEL
082-257-5201
hmaru@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoriko Doudou |
Organization
Hiroshima University
Division name
Department of Clinical Neuroscience and Therapeutics
Zip code
Address
1-2-3 Kasumi Minamiku Hiroshima-shi
TEL
082-257-5201
Homepage URL
dyoriko@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
self funding
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
| 2017 | Year | 06 | Month | 29 | 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
| 2017 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 03 | 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
| 2017 | Year | 06 | Month | 29 | Day |
Last modified on
| 2020 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032053
