UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030754 |
|---|---|
| Receipt number | R000035095 |
| Scientific Title | Quantitative analysis of dynamic postural instability in neurosurgical disorders |
| Date of disclosure of the study information | 2018/01/15 |
| Last modified on | 2023/01/16 09:45:54 |
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Basic information
Public title
Quantitative analysis of dynamic postural instability in neurosurgical disorders
Acronym
Quantitative analysis of dynamic postural instability in neurosurgical disorders
Scientific Title
Quantitative analysis of dynamic postural instability in neurosurgical disorders
Scientific Title:Acronym
Quantitative analysis of dynamic postural instability in neurosurgical disorders
Region
| Japan |
Condition
Condition
Neurological disorders
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Postural instability is major concerns due to risk of falling and deterioration in activities of daily living and quality of life in neurological disorders. Many studies report posturographic data; however, these results were contradictory among studies. Falls occur mainly during posture changes. Therefore, ground perturbation using mobile platform was applied for evaluating dynamic postural regulation. Posturographic study during voluntary axial movement has not been evaluated so far. In this study, we applied voluntary repetitive rotational movement of head and thorax, and evaluated postural stability during the self-paced axial movement. In our measurement system, both of voluntary movement and displacement of center of pressure were evaluated simultaneously, and the relationship between axial movement and postural stability would be clarified.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analysis of deviation of center of foot pressure
Functional balance scale
Timed Up and Go test
Unified Parkinsons Disease Rating Scale
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with the following clinical diagnosis will be included in this study
Parkinson's disease
Normal pressure hydrocephalus
Stroke
Brain tumor
2. Normal volunteers
Key exclusion criteria
Age less than 20 years old
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshinori |
| Middle name | |
| Last name | Higuchi |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Neurological Surgery
Zip code
260-8670
Address
Inohana 1-8-1, Chuo-ku, Chiba City, Chiba 260-8670, Japan
TEL
043-226-2158
yhiguchi@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Yoshinori |
| Middle name | |
| Last name | Higuchi |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Neurological Surgery
Zip code
260-8670
Address
Inohana 1-8-1, Chuo-ku, Chiba City, Chiba 260-8670, Japan
TEL
043-226-2158
Homepage URL
yhiguchi@faculty.chiba-u.jp
Sponsor or person
Institute
Department of Neurological Surgery
Chiba University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research (C)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University Graduate School of Medicine
Address
1-8-1 Inohana, Chuo-ku, Chiba
Tel
043-226-2158
yhiguchi@faculty.chiba-u.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
| 2018 | Year | 01 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
One year follow up will be required in the patients treated surgically.
Management information
Registered date
| 2018 | Year | 01 | Month | 10 | Day |
Last modified on
| 2023 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035095
| Research Plan | |
|---|---|
| Registered date | File name |
| 2019/01/11 | 2785計画書＿最終.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
