UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045748 |
|---|---|
| Receipt number | R000052225 |
| Scientific Title | Verification of the effectiveness of a Unilateral space neglect treatment support system using MR |
| Date of disclosure of the study information | 2021/10/14 |
| Last modified on | 2021/10/14 10:27:40 |
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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
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
jubi@waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052225
