UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022178
Receipt number R000025548
Scientific Title An exploratory study on effects of visual cueing by wearable smart glasses to improve gait disturbance in patients with diseases involving basal ganglia
Date of disclosure of the study information 2016/05/23
Last modified on 2018/11/03 13:59:41

* 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

An exploratory study on effects of visual cueing by wearable smart glasses to improve gait disturbance in patients with diseases involving basal ganglia

Acronym

An exploratory 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 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 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

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Atsushi Iwata

Organization

The University of Tokyo Hospital

Division name

Department of Neurology

Zip code


Address

7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan

TEL

03-5800-8672

Email

iwata-tky@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Atsushi Iwata

Organization

The University of Tokyo Hospital

Division name

Department of Neurology

Zip code


Address

7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan

TEL

03-5800-8672

Homepage URL


Email

iwata-tky@umin.ac.jp


Sponsor or person

Institute

Department of Neurology, The University of Tokyo

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology, Japan

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor

Institute of Photon Science and Technology, The University of Tokyo

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

東京大学医学部附属病院(東京都)


Other administrative information

Date of disclosure of the study information

2016 Year 05 Month 23 Day


Related information

URL releasing protocol


Publication of results

Published


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

2016 Year 05 Month 23 Day

Date of IRB


Anticipated trial start date

2016 Year 05 Month 23 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 05 Month 02 Day

Last modified on

2018 Year 11 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025548


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name