UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046720 |
|---|---|
| Receipt number | R000053297 |
| Scientific Title | Research and development for screening system of Mild Cognitive Impairment (MCI) |
| Date of disclosure of the study information | 2022/01/25 |
| Last modified on | 2024/07/23 13:24:55 |
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Basic information
Public title
Research and development for screening system of Mild Cognitive Impairment (MCI)
Acronym
Research and development for screening system of Mild Cognitive Impairment (MCI)
Scientific Title
Research and development for screening system of Mild Cognitive Impairment (MCI)
Scientific Title:Acronym
Research and development for screening system of Mild Cognitive Impairment (MCI)
Region
| Japan |
Condition
Condition
older adults, mild cognitive impairment
Classification by specialty
| Geriatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We used a training device (iWakka) for the quantitative evaluation of motor sequence learning memory. This study was to develop a new method to distinguish MCI from an unimpaired condition.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mean Absolute Error
AGF: Adjustability of Grasping Force
Key secondary outcomes
1,General Function(age,sex,education)
2,Cognitive Function(MMSE,HDS-R,TMTA/B,FAB,Rey-Osterrieth Complex Figure Test)
3,Physiology Factors(pupil diameter,sight)
4,Diagnostic Imaging(SPECT)
5,Psycho-social Factors(BDI2)
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
| 60 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Above 60 years who are able to operate the equipment.
Key exclusion criteria
1. People with health problems such as orthopedic disease.
2. People with health problems such as stroke and other central nervous system disease.
3. People with health problems such as peripheral nerve disorder.
4. People with health problems such as mental disease.
5. People with health problems such as cognitive function.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kazuya |
| Middle name | |
| Last name | Toshima |
Organization
Kaikoukai Rehabilitation Hospital
Division name
Department of Rehabilitation
Zip code
490-1405
Address
5-20,Kando,Yatomi-shi, Aichi
TEL
0567-52-3883
k-toshima@kaikou.or.jp
Public contact
Name of contact person
| 1st name | Kazuya |
| Middle name | |
| Last name | Toshima |
Organization
Kaikoukai Rehabilitation Hospital
Division name
Department of Rehabilitation
Zip code
490-1405
Address
5-20,Kando,Yatomi-shi, Aichi
TEL
0567-52-3883
Homepage URL
k-toshima@kaikou.or.jp
Sponsor or person
Institute
Kaikoukai Rehabilitation Hospital
Department of Rehabilitation
Institute
Department
Personal name
Funding Source
Organization
Kaikoukai Rehabilitation Hospital
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
Kaikoukai Healthcare corporation Nagoya Kyoritsu Hospital
Address
1-172 Hokke, Nakagawa-ku, Nagoya-shi, Aichi
Tel
052-362-5151
somu@kaikou.or.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 01 | Month | 25 | 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
| 2021 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
[Inspection and measurement items]
1,General Function(age,sex,education)
2,Cognitive Function(MMSE,HDS-R,TMTA/B,FAB,Rey-Osterrieth Complex Figure Test)
3,Physiology Factors(pupil diameter,sight)
4,Diagnostic Imaging(SPECT)
5,Psycho-social Factors(BDI2)
Management information
Registered date
| 2022 | Year | 01 | Month | 25 | Day |
Last modified on
| 2024 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053297
