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'
Conditions
Interventions
Somato-Cognitive Coordination Therapy (SCCT) using Virtual Reality (VR) equipment
Sponsors
mediVR, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1) Individuals deemed unsuitable for participation in the study by the attending physician, principal investigator or co-investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan,Asia(except Japan),Europe
Contacts
Public ContactMasatake Tamaki
The Japan Society of Clinical Reesarch Department of Clinical Investigation
Outcome results
None listed