UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054734 |
|---|---|
| Receipt number | R000062397 |
| Scientific Title | Prospective Interventional Study on the Clinical Effect of Somatic-Cognitive Coordination Therapy Using mediVR KAGURA |
| Date of disclosure of the study information | 2024/06/24 |
| Last modified on | 2024/06/23 19:49:58 |
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Basic information
Public title
Prospective Interventional Study on the Clinical Effect of Somatic-Cognitive Coordination Therapy Using mediVR KAGURA
Acronym
mediVR-SCCT Study
Scientific Title
Prospective Interventional Study on the Clinical Effect of Somatic-Cognitive Coordination Therapy Using mediVR KAGURA
Scientific Title:Acronym
mediVR-SCCT Study
Region
| Japan |
Condition
Condition
Cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will examine the improvement effects of mediVR kagura-guided rehabilitation (also called somatic cognitive coordination therapy) on various physical and cognitive function indices. The data will be used on hospitalized patients, and the effects will be collected as data from a prospective intervention study. Data will also be collected and compared on patients with multiple illnesses who do not use the Kagura.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Before and after mediVR kagura-guided rehabilitation, the following indices are measured and evaluated according to the underlying disease and pathological condition. Various physical function evaluation indices: 10-meter walk test, Timed up and go test (TUG), Functional Independence Measure (FIM), Berg balance scale (BBS), constant values of gravity center sway measurement, etc. Various cognitive function assessment indices: Mini-Mental State, Hasegawa Simplified Intelligence Scale (HDS-R), Self-Rating Depression Scale (SDS) score, and for patients with higher brain dysfunction, the presence of reactivity and spontaneity. Other indicators deemed necessary by the researcher. However, variables to be obtained will be selected as appropriate depending on the situation and necessity.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The clinical research period is from February 19, 2024 to March 31, 2027. The number of subjects will be approximately 10-15 for each disease or condition (however, more subjects' data will be collected to the extent possible for more accurate analysis). Rehabilitation with mediVR Kagura 2-3 times per week.
Interventions/Control_2
Patients who receive usual rehabilitation for a similar disease group will be the control group. The duration of the clinical study for the control group will be the same.
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 who meet the following criteria are eligible.
1) Patients with physical dysfunction (ataxia, gait and balance disorders, upper limb dysfunction, dysarthria, dysphagia, etc.) or cognitive dysfunction (higher brain dysfunction, attention disorder, hemispatial neglect, etc.)
2) Patients who are treated as outpatients or inpatients at the hospital, and whose written consent for participation in the study has been obtained from the patient or a surrogate (relative up to the fifth degree of kinship).
Key exclusion criteria
Patients who cannot live. Patients who are unable to sit in a wheelchair. Patients who cannot be rehabilitated in the training room.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yuta |
| Middle name | |
| Last name | Oi |
Organization
National Hospital Organization Maizuru Medical Center
Division name
Neurosurgery
Zip code
625-8502
Address
Maizuru Medical Center, 2410 Aza-Yukinaga, Maizuru, Kyoto, Japan
TEL
0773622680
406-maizuru-mc@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Oi |
Organization
National Hospital Organization Maizuru Medical Center
Division name
Neurosurgery
Zip code
625-8502
Address
Maizuru Medical Center, 2410 Aza-Yukinaga, Maizuru, Kyoto, Japan
TEL
0773622680
Homepage URL
406-maizuru-mc@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Maizuru Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Maizuru Medical Center
Address
Maizuru Medical Center, 2410 Aza-Yukinaga, Maizuru, Kyoto, Japan
Tel
0773622680
406-maizuru-mc@mail.hosp.go.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
| 2024 | Year | 06 | Month | 24 | 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
| 2024 | Year | 02 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 19 | Day |
Last follow-up date
| 2027 | 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
| 2024 | Year | 06 | Month | 23 | Day |
Last modified on
| 2024 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062397
