UMIN-CTR Clinical Trial

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

unilateral spatial neglect

Classification by specialty

Neurology	Neurosurgery	Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Subjective straight ahead pointing immediately after the intervention

Key secondary outcomes

line bisection
line cancellation
star cancellation

Study type

Interventional

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

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

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

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

Email

numao@sigg.ac.jp

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

Email

higebz@yahoo.co.jp

Institute

Tokyo Metropolitan University

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Tokyo Metropolitan University

Address

7-2-10 Higashi-Ogu, Arakawa-ku, Tokyo, Japan

Tel

03-3819-1211

Email

rinri-hs@tmu.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2020

Year

11

Month

07

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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