UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025362
Receipt number 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 2023/06/26 16:00:43

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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 or person

Institute

Gunma University

Institute

Department

Personal name



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

2023 Year 06 Month 26 Day



Link to view the page

Value
https://center6.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