UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017171 |
|---|---|
| Receipt number | R000019922 |
| Scientific Title | Gait analysis study in spinocerebellar degeneration and parkinson disease |
| Date of disclosure of the study information | 2015/04/19 |
| Last modified on | 2015/11/20 15:23:48 |
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Basic information
Public title
Gait analysis study in spinocerebellar degeneration and parkinson disease
Acronym
Gait analysis in SCD and PD
Scientific Title
Gait analysis study in spinocerebellar degeneration and parkinson disease
Scientific Title:Acronym
Gait analysis in SCD and PD
Region
| Japan |
Condition
Condition
spinocerebellar degeneration and parkinson disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We performed gait analysis in patients with spinocerebellar degeneration/parkinson disease and assessed whether the obtained data could be used as a neurophysiological biomarker for cerebellar ataxia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The comparison of the average and CV of the amplitude of gait between patients and healthy control subjects.
Key secondary outcomes
The correlation analysis between each parameter with the clinical severity and the average and CV of the amplitude of gait
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
Patients with spinocerebellar degeneration and parkinson disease in Hokkaido University Hospital and kushiro Rosai Hospital/
Key exclusion criteria
Patients with cognitive decline
Patients who can not sit down alone for an hour
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidenao Sasaki |
Organization
Hokkaido University Hospital
Division name
Department of Neurology
Zip code
Address
N14W5 Kita-ku Sapporo
TEL
011-706-6028
h-isasak@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ichiro Yabe |
Organization
Hokkaido University Hospital
Division name
Department of Neurology
Zip code
Address
N14W5 Kita-ku Sapporo
TEL
011-706-6028
Homepage URL
yabe@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
a Grant-in-Aid for the Research Committee for Ataxic Diseases of the Research on Measures for Intractable Diseases from the Ministry of Health, Welfare and Labor, Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kushiro Rosai Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 04 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
http://www.sciencedirect.com/science/article/pii/S0022510X15020699
Number of participants that the trial has enrolled
Results
Gait analysis by accelerometer is a quantitative and concise
evaluation scale for the severity of cerebellar ataxia.
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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 08 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 21 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Gait analysis by accelerometer is in progress.
Management information
Registered date
| 2015 | Year | 04 | Month | 19 | Day |
Last modified on
| 2015 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019922
