UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042379 |
|---|---|
| Receipt number | R000048372 |
| Scientific Title | Immediate effects of head mounted display adaptation in patients with unilateral spatial neglect |
| Date of disclosure of the study information | 2020/11/07 |
| Last modified on | 2021/06/14 14:13:46 |
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Basic information
Public title
The Effect of Reaching Activities with Deviated Vision on Spatial Cognition
Acronym
The Effect of Reaching Activities with Deviated Vision on Spatial Cognition
Scientific Title
Immediate effects of head mounted display adaptation in patients with unilateral spatial neglect
Scientific Title:Acronym
Immediate effects of head mounted display adaptation in patients with unilateral spatial neglect
Region
| Japan |
Condition
Condition
unilateral spatial neglect
Classification by specialty
| Neurology | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effect of adaptation in the triaxial deviated field of view on spatial perception in patients with unilateral spatial neglect.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Subjective straight ahead pointing immediately after the intervention
Key secondary outcomes
line bisection
line cancellation
star cancellation
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment | Behavior,custom | Maneuver |
Interventions/Control_1
Subjects wear an HMD with a camera mounted on it. The camera is tilted 10 degrees to the left in the horizontal plane, clockwise on the front face, and downward in the sagittal plane. Four targets are displayed in front of the chest, and the subjects are asked to point 48 times at random while looking at them through the HMD.
Interventions/Control_2
Subjects wear an HMD with a camera mounted on it. The camera is tilted 10 degrees to the left in the horizontal plane. Four targets are displayed in front of the chest, and the subjects are asked to point 48 times at random while looking at them through the HMD.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with right hemisphere cerebrovascular disease
Hospitalization within 6 months of stroke
No severe dementia
With unilateral spatial neglect
Wheelchair or chair position available
The consent of the attending physician has been obtained
Key exclusion criteria
Wheelchair seating is not possible
Inability to understand tasks due to aphasia or other cognitive impairment
inability to understand Japanese
visual impairment
Severe hearing loss
Inability to reach due to lack of range of motion in the right upper extremity
Amputation of the right upper extremity proximal to half of the forearm.
Severe positional sensory impairment of the right finger due to peripheral neuropathy
Patient refusal to participate
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Taku |
| Middle name | |
| Last name | Numao |
Organization
Japanese School of Technology for Social Medicine
Division name
Physical Therapy
Zip code
184-8508
Address
2-22-32, Naka-cho, Koganei-city, Tokyo, Japan
TEL
042-384-1030
numao@sigg.ac.jp
Public contact
Name of contact person
| 1st name | Taku |
| Middle name | |
| Last name | Numao |
Organization
Japanese School of Technology for Social Medicine
Division name
Physical Therapy
Zip code
184-8508
Address
2-22-32, Naka-cho, Koganei-city, Tokyo, Japan
TEL
042-384-1030
Homepage URL
higebz@yahoo.co.jp
Sponsor or person
Institute
Tokyo Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
None
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
Tokyo Metropolitan University
Address
7-2-10 Higashi-Ogu, Arakawa-ku, Tokyo, Japan
Tel
03-3819-1211
rinri-hs@tmu.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | Month | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 15 | 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
| 2020 | Year | 11 | Month | 07 | Day |
Last modified on
| 2021 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048372
