UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000017171
Receipt No. 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

* 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 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
Email 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
Email yabe@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019922

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.