UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056108 |
|---|---|
| Receipt number | R000064109 |
| Scientific Title | Randomized Controlled Trial on the Clinical Effectiveness of Somato-Cognitive Coordination Therapy using mediVR KAGURA in Chronic Cerebellar Infarction and Hemorrhage |
| Date of disclosure of the study information | 2024/11/08 |
| Last modified on | 2024/11/08 18:24:20 |
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Basic information
Public title
Randomized Controlled Trial on the Clinical Effectiveness of Somato-Cognitive Coordination Therapy using mediVR KAGURA in Chronic Cerebellar Infarction and Hemorrhage
Acronym
RCT of Somato-Cognitive Coordination Therapy using mediVR KAGURA in Chronic Cerebellar Infarction and Hemorrhage
Scientific Title
Randomized Controlled Trial on the Clinical Effectiveness of Somato-Cognitive Coordination Therapy using mediVR KAGURA in Chronic Cerebellar Infarction and Hemorrhage
Scientific Title:Acronym
RCT of Somato-Cognitive Coordination Therapy using mediVR KAGURA in Chronic Cerebellar Infarction and Hemorrhage
Region
| Japan |
Condition
Condition
Chronic cerebellar infarction and hemorrhage
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to verify the improvement effects of mediVR KAGURA-guided rehabilitation (also known as somato-cognitive coordination therapy) on various physical and cognitive function indicators. This is applied to inpatients, and data on its effects are collected as part of a randomized controlled trial. Comprehensive analyses are conducted on patients with various conditions, comparing those who use KAGURA with those who do not.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The following indicators are measured and evaluated at the beginning of rehabilitation in the training room and 2 weeks after the start of rehabilitation. Common assessment measures: Functional Independence Measure (FIM), Stroke impairment Assessment Set (SIAS), 10-meter walk test, Timed up and go test (TUG), Brunnstrom Stages (BRST), Fugl-Meyer Assessment (FMA), Motor Activity Log (MAL), Box and Block Test (BBT), Mini-Mental State Examination (MMSE), Frontal Assessment Battery (FAB), and Trail Making Test (TMT).
Patients with ataxia: Scale for the Assessment and Rating of Ataxia (SARA). Patients with attention disorders: line and star blotting. Patients with dysarthria: Assessment of Motor Speech for Dysarthria (AMSD), Oral diadochokinesis: Scale for Contraversive pushing (SCP). Other measures deemed necessary by the investigator.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
Patients who meet all of the following criteria who are randomly assigned to the group using the mediVR Kagura.
1) Patients who have experienced cerebellar infarction or cerebellar hemorrhage for more than six months
2) Patients with a consciousness level of JCS 0-10 and amenable to follow-up
3) Patients who can be intervened in the training room in a wheelchair sitting position
4) Patients with physical dysfunction (ataxia, gait and balance problems, upper limb dysfunction, dysarthria, dysphagia, etc.) or cognitive dysfunction (higher brain dysfunction, attention disorder, hemispatial neglect, etc.)
5) Patients who have obtained written consent for participation in the study from the patient or a surrogate (relative up to the fifth degree of kinship) within 10 days of the start of the intervention in the training room after fulfilling 1)-4) above.
Interventions/Control_2
Patients who meet all of the following criteria who are randomly assigned to the group that does not use the mediVR Kagura.
1) Patients who have experienced cerebellar infarction or cerebellar hemorrhage for more than six months
2) Patients with a consciousness level of JCS 0-10 and amenable to follow-up
3) Patients who can be intervened in the training room in a wheelchair sitting position
4) Patients with physical dysfunction (ataxia, gait and balance problems, upper limb dysfunction, dysarthria, dysphagia, etc.) or cognitive dysfunction (higher brain dysfunction, attention disorder, hemispatial neglect, etc.)
5) Patients who have obtained written consent for participation in the study from the patient or a surrogate (relative up to the fifth degree of kinship) within 10 days of the start of the intervention in the training room after fulfilling 1)-4) above.
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 all of the following criteria will be considered.
1) Patients who have experienced cerebellar infarction or cerebellar hemorrhage for more than six months
2) Patients with a consciousness level of JCS 0-10 and amenable to follow-up
3) Patients who can be intervened in the training room in a wheelchair sitting position
4) Patients with physical dysfunction (ataxia, gait and balance problems, upper limb dysfunction, dysarthria, dysphagia, etc.) or cognitive dysfunction (higher brain dysfunction, attention disorder, hemispatial neglect, etc.)
5) Patients who have obtained written consent for participation in the study from the patient or a surrogate (relative up to the fifth degree of kinship) within 10 days of the start of the intervention in the training room after fulfilling 1)-4) above.
Key exclusion criteria
Those deemed inappropriate for participation in the study by the principal investigator or research associate
Target sample size
20
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
6258502
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 | 11 | Month | 08 | 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 | 10 | Month | 07 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 07 | 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 | 11 | Month | 08 | Day |
Last modified on
| 2024 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064109
