UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056037 |
|---|---|
| Receipt number | R000064039 |
| Scientific Title | Evaluating the Efficacy of VR-Based Somato-Cognitive Coordination Therapy Across Diseases: A Multicenter Prospective Intervention Study |
| Date of disclosure of the study information | 2024/11/04 |
| Last modified on | 2024/11/06 14:11:12 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluating the Efficacy of VR-Based Somato-Cognitive Coordination Therapy Across Diseases: A Multicenter Prospective Intervention Study
Acronym
RECOVER trial
Scientific Title
Evaluating the Efficacy of VR-Based Somato-Cognitive Coordination Therapy Across Diseases: A Multicenter Prospective Intervention Study
Scientific Title:Acronym
REprogramming COordination through Virtual Environment Rehabilitation Trial
Region
| Japan | Asia(except Japan) | Europe |
Condition
Condition
We will consider the following diseases as potential research subjects, assessing the feasibility of conducting the study based on the capabilities of each facility. Neurology: Stroke, ataxia, hemispatial neglect, Parkinson's disease, multiple system atrophy, spinocerebellar degeneration, progressive supranuclear palsy, higher cortical dysfunctions, amyotrophic lateral sclerosis, migraine. Orthopedics: Spinal cord injury, periarthritis, radial nerve palsy, post-traffic accident neck pain, lumbar spinal stenosis, knee osteoarthritis, post-operative femur fractures, frailty, sarcopenia. Pediatrics: Cerebral palsy, autism spectrum disorders, developmental coordination disorders, ADHD, spinal muscular atrophy, muscular dystrophy. Anesthesiology: CPSP, CRPS, fibromyalgia, other chronic pain. Malignancy: Chemotherapy-induced neuropathy, chemobrain. Cardiology: Heart failure. Respirology: COPD. Infection: Post-COVID-19 sequelae, herpes zoster. Psychiatry: Depression, schizophrenia.
Classification by specialty
| Medicine in general | Cardiology | Pneumology |
| Neurology | Psychosomatic Internal Medicine | Infectious disease |
| Surgery in general | Pediatrics | Psychiatry |
| Orthopedics | Anesthesiology | Neurosurgery |
| Plastic surgery | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to ascertain the therapeutic efficacy of Somato-Cognitive Coordination Therapy (SCCT) using virtual reality (VR) technology across various diseases and symptoms. Additionally, this trial, registered under UMIN-CTR ID: UMIN000041770, aims to expand the participating facilities and clarify the target diseases, and will undergo re-evaluation by the ethics committee for these purposes. Consequently, patient enrollment will be retroactively applied to the point of the initial UMIN000041770 registration.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Based on the underlying disease and clinical state, various indices such as disease-specific tests and blood data (biomarkers) will be measured and evaluated as primary endpoints. However, researchers may also set additional indices they deem necessary as evaluation criteria.
Various physical function assessment indices include: the 10-meter walk test, Timed Up and Go test (TUG), Functional Independence Measure (FIM), Berg Balance Scale (BBS), Fugl-Meyer Assessment (FMA), Manual Muscle Test (MMT), Box and Block Test (BBT), Simple Test for Evaluating Hand Function (STEF), pegboard test, finger-to-nose test, single-leg stance test, Scale for the Assessment and Rating of Ataxia (SARA), stabilometry, the A-I-U-E-O test, presence of diplopia, muscle strength including grip strength, among others.
Various cognitive function assessment indices include: Mini-Mental State Examination (MMSE), Hasegawa's Dementia Scale-Revised (HDS-R), Self-Rating Depression Scale (SDS) score, Trail Making Test (TMT-A/B), Line Bisection Test, and assessments of reactivity and spontaneity in patients with higher cortical dysfunctions.
Additionally, disease-specific indices such as the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) will be selectively used as needed, based on feasibility and necessity for each disease subcategory within the RECOVER trial.
Assessment points will be set at the initial visit before and after SCCT, and subsequently at discretionary time points. These can be demarcated by duration, such as approximately one month, three months, six months, nine months, and one year after the start of treatment, or by the number of SCCT sessions, such as after 5 or 10 sessions.
Key secondary outcomes
Based on the underlying disease and clinical state, various indices such as disease-specific tests and blood data (biomarkers) will also be measured and evaluated as secondary endpoints. However, researchers may also set additional indices they deem necessary as evaluation criteria.
Various physical function assessment indices include: the 10-meter walk test, Timed Up and Go test (TUG), Functional Independence Measure (FIM), Berg Balance Scale (BBS), Fugl-Meyer Assessment (FMA), Manual Muscle Test (MMT), Box and Block Test (BBT), Simple Test for Evaluating Hand Function (STEF), pegboard test, finger-to-nose test, single-leg stance test, Scale for the Assessment and Rating of Ataxia (SARA), stabilometry, the A-I-U-E-O test, presence of diplopia, muscle strength including grip strength, among others.
Various cognitive function assessment indices include: Mini-Mental State Examination (MMSE), Hasegawa's Dementia Scale-Revised (HDS-R), Self-Rating Depression Scale (SDS) score, Trail Making Test (TMT-A/B), Line Bisection Test, and assessments of reactivity and spontaneity in patients with higher cortical dysfunctions.
Additionally, disease-specific indices such as the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) will be selectively used as needed, based on feasibility and necessity for each disease subcategory within the RECOVER trial.
Assessment points will be set at the initial visit before and after SCCT, and subsequently at discretionary time points. These can be demarcated by duration, such as approximately one month, three months, six months, nine months, and one year after the start of treatment, or by the number of SCCT sessions, such as after 5 or 10 sessions.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Somato-Cognitive Coordination Therapy (SCCT) using Virtual Reality (VR) equipment
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
| 1 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients who present with physical or cognitive impairments and have been assessed by two or more physicians as having no further improvement in symptoms or functions with current medical interventions, or who have not shown improvement in subjective symptoms and objective physical-cognitive assessment indicators despite receiving treatment in the past six months.
2) Individuals who have provided consent for participation in the study, either personally or through a legally authorized representative
Key exclusion criteria
1) Individuals deemed unsuitable for participation in the study by the attending physician, principal investigator or co-investigators
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Hara |
Organization
mediVR, Inc.
Division name
Department of Neurology and Clinical Rehabilitation, mediVR Rehabilitation Center
Zip code
561-0872
Address
Ryokuchi Station Building 3F, Terauchi 2-chome 4-1, Toyonaka
TEL
06-6151-4008
hara@medivr.jp
Public contact
Name of contact person
| 1st name | Masatake |
| Middle name | |
| Last name | Tamaki |
Organization
The Japan Society of Clinical Reesarch
Division name
Department of Clinical Investigation
Zip code
561-0871
Address
Higashiterauchi-cho 1-10-446, Toyonaka, Osaka
TEL
81-90-7593-2229
Homepage URL
info@japanscr.org
Sponsor or person
Institute
mediVR, Inc.
Institute
Department
Personal name
Funding Source
Organization
Not applicable
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
Ethical Comittee of the Japan Society of Clinical Research
Address
Higashiterauchi-cho 1-10-446, Toyonaka, Osaka
Tel
81-90-7593-2229
info@japanscr.org
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 | 04 | 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 | 11 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2029 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 04 | Day |
Last modified on
| 2024 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064039
