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 | 2024/06/27 09:19:20 |
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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
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
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
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
https://www.sciencedirect.com/science/article/pii/S0967586819314171?via%3Dihub
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S0967586819314171?via%3Dihub
Number of participants that the trial has enrolled
75
Results
The average stride length was shorter in ataxic subjects or Parkinson disease subjects than in control subjects. The average feet interval was larger in ataxic subjects than in control subjects. The stride length coefficient of variation (CV), gait rhythm CV, and average and standard deviations of the A/L ratio were larger in ataxic or Parkinson disease subjects than in control subjects.
Results date posted
| 2024 | Year | 06 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
25 ataxic, 25 Parkinson disease, and 25 control
Participant flow
evaluated their walk
Adverse events
Nothing
Outcome measures
Stride length, feet interval, gait rhythm, and a ratio of the actual walking route length to the linear distance between the start and goal points (A/L ratio) were assessed and compared. Outcome correlations with clinical scales were also analyzed.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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
| 2024 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028927
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