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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025362
Receipt No. R000028927
Scientific Title Development of quantitative evaluation of walking disability for neurodegenerative diseases using an infrared depth-sensing camera
Date of disclosure of the study information 2016/12/21
Last modified on 2019/06/24

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Basic information
Public title Development of quantitative evaluation of walking disability for neurodegenerative diseases using an infrared depth-sensing camera
Acronym Quantitative evaluation of walking disability using an infrared depth-sensing camera
Scientific Title Development of quantitative evaluation of walking disability for neurodegenerative diseases using an infrared depth-sensing camera
Scientific Title:Acronym Quantitative evaluation of walking disability using an infrared depth-sensing camera
Region
Japan

Condition
Condition Spinocerebellar degeneration, Multiple system atrophy,Amyotrophic lateral sclerosis,Parkinson's syndrome
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We aim at development of quantitative evaluation of walking disability using an infrared depth-sensing camera.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Walk analysis with infrared depth-sensing camera (start time, 6 months, 12 months, 18 months, 24 months later)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Walk analysis with an infrared depth-sensing camera(Spinocerebellar degeneration,Multiple system atrophy group):start time, 6 months, 12 months, 18 months, 24 months later.
Interventions/Control_2 Walk analysis with an infrared depth-sensing camera(Amyotrophic lateral sclerosis group):start time, 6 months, 12 months, 18 months, 24 months later.
Interventions/Control_3 Walk analysis with an infrared depth-sensing camera(Parkinson's syndrome):start time, 6 months, 12 months, 18 months, 24 months later.
Interventions/Control_4 Walk analysis with an infrared depth-sensing camera(normal control group):start time, 6 months, 12 months, 18 months, 24 months later.
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
85 years-old >=
Gender Male and Female
Key inclusion criteria 1)
Spinocerebellar degeneration: Probable 2 or higher according to the diagnostic criteria of Japan Intractable Diseases Information Center.

Multiple system atrophy: probable or higher according to the diagnostic criteria of Multiple system atrophy. (Neurology 71:670-676, 2008)

Amyotrophic lateral sclerosis: clinically probable-laboratory-supported ALS or higher according to the diagnostic criteria of El Escorial revised Airlie House.

Parkinson's disease: Meet the diagnostic criteria of Japan Intractable Diseases Information Center.

2)
Patients without gait disturbance.
Key exclusion criteria 1) Patients with a history of intracranial disease and spinal cord disease other than the target disease.
2) Patients with sensory ataxia.
3) Patients judged inappropriate by the doctor.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Yoshio
Middle name
Last name Ikeda
Organization Gunma University Graduate School of Medicine
Division name Department of Neurology
Zip code 371-8511
Address 3-39-22 Showa-machi, Maebashi, Gunma 371-8511, Japan.
TEL 027-220-7111
Email ikeday006@gunma-u.ac.jp

Public contact
Name of contact person
1st name Setsuki
Middle name
Last name Tsukagoshi
Organization Gunma University Graduate School of Medicine
Division name Department of Neurology
Zip code 371-8511
Address 3-39-22 Showa-machi, Maebashi, Gunma 371-8511, Japan.
TEL 027-220-7111
Homepage URL
Email tukagos@gunma-u.ac.jp

Sponsor
Institute Gunma University
Institute
Department

Funding Source
Organization Gunma University
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 Gunma University Graduate School of Medicine institutional review board
Address 3-39-15 Showa-machi, Maebashi, Gunma 371-8511, Japan.
Tel 027-220-8740
Email tukagos@gunma-u.ac.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 群馬大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 21 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 Open public recruiting
Date of protocol fixation
2016 Year 11 Month 30 Day
Date of IRB
2016 Year 11 Month 30 Day
Anticipated trial start date
2016 Year 12 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 21 Day
Last modified on
2019 Year 06 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028927

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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