UMIN-CTR Clinical Trial

Basic information
Public title	Verification of the effectiveness of a Unilateral space neglect treatment support system using MR
Acronym	Verification of the effectiveness of a Unilateral space neglect treatment support system using MR
Scientific Title	Verification of the effectiveness of a Unilateral space neglect treatment support system using MR
Scientific Title:Acronym	Verification of the effectiveness of a Unilateral space neglect treatment support system using MR
Region	Japan

Condition
Condition	Unilateral spatial neglect
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Verification of the effect of applying the developed system on the improvement of neglect symptoms in daily life
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Catherine Bergego Scale Time of assessment immediately before the intervention and immediately after the intervention
Key secondary outcomes	Behavioural inattention test Slalom test Measuring neglected areas using immersive VR Time of assessment immediately before the intervention and immediately after the intervention

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Have the patient wear the HMD and present multiple holograms superimposed at shoulder height and on the ground in real space. The patient moves around the rehabilitation space in a wheelchair or by walking while visually exploring the space. After recognizing the holograms, the patient touches the shoulder-level hologram with his/her hand or reads the text on the hologram. For holograms on the ground, touch them with the hand. This intervention will be conducted for 20 minutes a day for two weeks.
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Unilateral spatial neglect patient 2.person who can perform a line erasure in the front midline without the assistance of a third party. 3. person who is not hemianopsia 4.person in the hyperacute stage or later, more than 2 weeks after the onset of illness 5. Hemiplegic stroke patients in a rehabilitation hospital
Key exclusion criteria	1. Uncontrolled heart failure 2. Acute myocardial infarction 3. Active myocarditis or pericarditis 4. Unstable angina 5. Acute systemic embolism or pulmonary embolism 6. Acute infection 7. Thrombophlebitis 8. Ventricular tachycardia or refractory ventricular arrhythmia 9. Severe ventricular outflow tract obstruction 10. Uncontrolled arterial or pulmonary hypertension 11. Those who are not capable of performing the tasks indicated in the test procedure (including breaks between tasks) 12. Those with obvious hemianopsia 13. Mini Mental State Examination (MMSE): 21 points or less (unless able to take and answer) 14. The very elderly (90 years old and above) 15. Functional Independent Measure (FIM) cognitive items: 20 points or less 16. Japan ComaScale (JCS) 3 digits or more Exclusion criteria are determined by the attending physician
Target sample size	28

Research contact person
Name of lead principal investigator	1st name Hiroyasu Middle name Last name Iwata
Organization	Waseda University
Division name	Faculty science and engineering
Zip code	162-0042
Address	Room 603, Green Computing Systems Research Organization, Building 40, Waseda University, 27 Waseda-cho, Shinjuku-ku, Tokyo
TEL	03-3203-4427
Email	jubi@waseda.jp

Public contact
Name of contact person	1st name Hiroyasu Middle name Last name Iwata
Organization	Waseda University
Division name	Faculty science and engineering
Zip code	162-0042
Address	Room 603, GCS, Building 40, Waseda University, 27 Waseda-cho, Shinjuku-ku, Tokyo
TEL	03-3203-4427
Homepage URL
Email	jubi@waseda.jp

Sponsor
Institute	Waseda University
Institute
Department

Funding Source
Organization	Waseda University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	medical corporation sonoda-kai sonoda-kai rehabilitation hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Committee of Waseda University
Address	1-104 Totsuka-cho, Shinjyuku-ku, Tokyo 169-8050
Tel	03-5272-1639
Email	rinri@list.waseda.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	医療法人社団苑田会苑田会リハビリテーション病院(東京都)

Other administrative information
Date of disclosure of the study information	2021 Year 10 Month 14 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	Preinitiation
Date of protocol fixation	2021 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date	2021 Year 11 Month 01 Day
Last follow-up date	2026 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	2021 Year 10 Month 14 Day
Last modified on	2021 Year 10 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052225