UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032243 |
|---|---|
| Receipt number | R000036770 |
| 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 |
| Date of disclosure of the study information | 2018/04/13 |
| Last modified on | 2021/12/08 22:06:58 |
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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
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
nagashima-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036770
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
