UMIN-CTR Clinical Trial

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
Email	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
Email	dyoriko@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032053