UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of childhood movement disorders with wearable devices.
Title of the study (Brief title)	Analysis of childhood movement disorders with wearable devices.
Region	Japan

Condition
Condition	Movement Disorders
Classification by specialty	Neurology Pediatrics Adult Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Objective, quantitative, and reproducible severity scales for hyperkinetic movement disorders are yet to be developed. We take advantage of wearable accelerometer (actigraph) to evaluate pediatric movement disorders.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Whether activity indices from wearable devices coincide with the movement disorder clinical scales (cross-sectional study).
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Age-upper limit	18 years-old >=
Gender	Male and Female
Key inclusion criteria	patients with movement disorders
Key exclusion criteria	none
Target sample size	40

Research contact person
Name of lead principal investigator	Itaru Hayakawa
Organization	National Center for Child Health and Development
Division name	Neurology
Address	2-10-1, Okura, Setagaya-ku, Tokyo, Japan
TEL	0334160181
Email	hayakawa-i@ncchd.go.jp

Public contact
Name of contact person	Itaru Hayakawa
Organization	National Center for Child Health and Development
Division name	Neurology
Address	2-10-1, Okura, Setagaya-ku, Tokyo, Japan
TEL	0334160181
Homepage URL
Email	hayakawa-i@ncchd.go.jp

Sponsor
Institute	National Center for Child Health and Development
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	National Center for Child Health and Development
Name of secondary funｄer(s)

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	2018 Year 10 Month 10 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2018 Year 10 Month 01 Day
Anticipated trial start date	2018 Year 10 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	none

Management information
Registered date	2018 Year 10 Month 10 Day
Last modified on	2018 Year 10 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039272