UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055732 |
|---|---|
| Receipt number | R000063691 |
| Scientific Title | Standardization of the New Standard Higher-Order Mobility Test Method: Evaluation Appropriateness in Brain-Injury Cases |
| Date of disclosure of the study information | 2024/10/03 |
| Last modified on | 2024/12/09 17:12:07 |
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Basic information
Public title
Standardization of the New Standard Higher-Order Mobility Test Method: Evaluation Appropriateness in Brain-Injury Cases
Acronym
Standardization of the New Standard Higher-Order Mobility Test Method: Evaluation Appropriateness in Brain-Injury Cases
Scientific Title
Standardization of the New Standard Higher-Order Mobility Test Method: Evaluation Appropriateness in Brain-Injury Cases
Scientific Title:Acronym
Standardization of the New Standard Higher-Order Mobility Test Method: Evaluation Appropriateness in Brain-Injury Cases
Region
| Japan |
Condition
Condition
Outpatients with cerebrovascular disease and aphasia
Classification by specialty
| Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The revised version of the "New Standardized Test for Higher-Order Activities (hereinafter referred to as nSPTA)" was developed, and the test method was revised to adopt activities involving tool use that are more suited to everyday life situations, for example, (1) tool holding (hand and finger shape), (2) posture of hand to forearm, (3) tool-object relationship: direction of tool toward object, (4) properties of repetitive or single movements, and (5) the number of repetitive movements. The method should be revised to enable analytical and quantitative evaluation, for example: (1) the way the tool is held (shape of hand and fingers), (2) posture of hand to forearm, (3) tool-object relationship: direction of tool toward the object, (4) the nature of repetition or one movement.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1 Collection of basic information, FIM, and evaluation of activities of daily living 2 New and standard higher-order mobility test method 3 WAB act 4 SLTA (for left hemisphere injury) 5 Raven color matrix test (for left hemisphere injury) 6 Mini-Mental State Examination (MMSE-J) (for right hemisphere injury)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with cerebrovascular disorders and other central nervous system diseases Acquired brain injury (cerebrovascular disorders in about 80% of cases, other traumatic brain injuries, etc.), cases of degenerative diseases with clear loss of function (corticobasal syndrome, etc.) Cerebrovascular disorders are cases due to first seizure, and as a rule, cases with damage to one side of the cerebral hemisphere. Cases of cerebrovascular disease are due to first seizure, and as a rule, damage to the cerebral hemisphere on one side is observed. Cases of lacunar infarction without obvious neurological symptoms and white matter lesions that are not considered to affect cognitive function are acceptable.
Key exclusion criteria
Cases with impaired consciousness Cases in which the examination is difficult to perform due to psychiatric symptoms (delirium, emotional disturbance, etc.) Cases with acquired brain injury such as cerebrovascular disease or traumatic brain injury, dementia recognized before the onset of the disease, original intellectual decline or developmental disorder, cognitive decline due to medical disease Cases with uncorrectable hearing impairment that hinders the performance of the examination and visual impairment
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Sumio |
| Middle name | |
| Last name | Ishiai |
Organization
The Japan Society for Higher Brain Functions
Division name
Brain Function Test Committee
Zip code
1330052
Address
2-24-18 Higashikoiwa, Edogawa-ku, Tokyo
TEL
0336731557
office@higherbrain.or.jp
Public contact
Name of contact person
| 1st name | Youki |
| Middle name | |
| Last name | Teraoka |
Organization
Kawaguchi Neurosurgical Rehabilitation Clinic
Division name
Department of Rehabilitation
Zip code
5730086
Address
9-25-202 Koroen-cho, Hirakata-shi, Osaka-fu
TEL
0728351010
Homepage URL
kawaguchi.ns.reha@gmail.com
Sponsor or person
Institute
Kawaguchi Neurosurgical Rehabilitation Clinic
Institute
Department
Personal name
Funding Source
Organization
Japan Society for Higher Brain Dysfunction
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
Kawaguchi Neurosurgical Rehabilitation Clinic
Address
9-25-202 Koroen-cho, Hirakata-shi, Osaka-fu
Tel
0728351010
kawaguchi.ns.reha@gmail.com
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 | 10 | Month | 03 | 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
0
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
Terminated
Date of protocol fixation
| 2024 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Collection of basic information, FIM, and assessment of activities of daily living New and standard higher-order mobility test method WAB act SLTA (for left hemisphere injury) Raven Color Matrix Test (for left hemisphere injury) Mini-Mental State Examination (MMSE-J) (for right hemisphere injury)
Management information
Registered date
| 2024 | Year | 10 | Month | 03 | Day |
Last modified on
| 2024 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063691
