UMIN-CTR Clinical Trial

Basic information
Public title	An exploratory multi-institutional study on effects of visual cueing by wearable smart glasses to improve gait disturbance in patients with diseases involving basal ganglia
Acronym	An exploratory multi-institutional study on effects of visual cueing by wearable smart glasses to improve gait disturbance in patients with diseases involving basal ganglia
Scientific Title	An exploratory multi-institutional study on effects of visual cueing by wearable smart glasses to improve gait disturbance in patients with diseases involving basal ganglia
Scientific Title:Acronym	An exploratory multi-institutional study on effects of visual cueing by wearable smart glasses to improve gait disturbance in patients with diseases involving basal ganglia
Region	Japan

Condition
Condition	diseases involving basal ganglia
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficacy and safety of visual cueing by wearable smart glasses to improve freezing of gait
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase I,II

Assessment
Primary outcomes	percent time frozen
Key secondary outcomes	number of FOG(freezing of gait) events gait velocity time to initiate gait average stride length

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	group with smart glasses
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) Patients with diseases involving basal ganglia presenting freezing of gait 2) Patients in Hoehn & Yahr stage 3 to 4 3) Patients not younger than 20 years of age 4) Patients providing written informed consent
Key exclusion criteria	1) Patients with dementia (MMSE <= 21) 2) Patients with gait disturbance arising from causes other than extrapyramidal symptoms 3) Patients with severe visual impairment 4) Patients with severe depressive symptoms 5) When doctors decide that patients do not have eligibility for this study
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Tatsushi Middle name Last name Toda
Organization	The University of Tokyo Hospital
Division name	Department of Neurology
Zip code	113-8655
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL	03-5800-8672
Email	toda@m.u-tokyo.ac.jp

Public contact
Name of contact person	1st name Yu Middle name Last name Nagashima
Organization	The University of Tokyo Hospital
Division name	Department of Neurology
Zip code	113-8655
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL	03-5800-8672
Homepage URL
Email	nagashima-tky@umin.ac.jp

Sponsor
Institute	The University of Tokyo
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The University of Tokyo Hospital
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
Tel	03-5841-0818
Email	ethics@m.u-tokyo.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	東京大学医学部附属病院(東京都)/The University of Tokyo(Tokyo)

Other administrative information
Date of disclosure of the study information	2018 Year 04 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	Open public recruiting
Date of protocol fixation	2017 Year 11 Month 24 Day
Date of IRB	2017 Year 10 Month 25 Day
Anticipated trial start date	2017 Year 11 Month 24 Day
Last follow-up date	2025 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	2018 Year 04 Month 13 Day
Last modified on	2021 Year 12 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036770