UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048215 |
|---|---|
| Receipt number | R000054944 |
| Scientific Title | Examination of intervention effect by eye training in patients with mild cognitive impairment-randomized controlled trial- |
| Date of disclosure of the study information | 2022/07/01 |
| Last modified on | 2023/07/07 00:41:46 |
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Basic information
Public title
Examination of intervention effect by eye training in patients with mild cognitive impairment-randomized controlled trial-
Acronym
Examination of intervention effect by eye training in patients with mild cognitive impairment-randomized controlled trial-
Scientific Title
Examination of intervention effect by eye training in patients with mild cognitive impairment-randomized controlled trial-
Scientific Title:Acronym
Examination of intervention effect by eye training in patients with mild cognitive impairment-randomized controlled trial-
Region
| Japan |
Condition
Condition
Mild Cognitive Impairment
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Exploratory study of the effects of eye training in MCI patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Changes in MoCA-J 1 month after the start of intervention
Key secondary outcomes
Cognitive function evaluation index (MMSE, TMT-A / B), dynamic balance ability (IPS, closed eye IPS, open eye mIPS, mIPS), dynamic vision, grip strength, lower limb muscle strength (knee extension muscle strength, knee extension muscle endurance), piece Standing retention time, Change in body composition
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Eye movement training
1 set 20 times a day 3 sets a day for 1 month
Interventions/Control_2
1 month normal life
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
| 56 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Persons whose VPS> 1.0 was measured by a center of gravity sway meter conducted at Welcia Yakkyoku in Tsukuba City in the "Balance Ability Measurement Study"
2. Persons with a MoCA-J score of 25 or less conducted at the Tsukuba Preventive Medicine Research Center Cognitive Function Dock in the "Cognitive Function Dock Research"
3. Persons who have obtained written consent to participate in this research
Key exclusion criteria
1. Persons who are judged by the principal investigator to be inappropriate for inclusion in the research
2. Persons who did not participate in the evaluation before and after the implementation
3. Person who has been certified as requiring long-term care
4. Person who has a disability certificate
5. Persons with gait disorders due to dysfunction of hip joints, knee joints, etc.
6. Persons taking dementia treatment drugs
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Naoya |
| Middle name | |
| Last name | Yahagi |
Organization
University of Tsukuba
Division name
Endocrinology / Diabetology
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba City, Ibaraki Prefecture
TEL
029-853-3053
tsubaki2308@gmail.com
Public contact
Name of contact person
| 1st name | Takumi |
| Middle name | |
| Last name | Tsubaki |
Organization
University of Tsukuba hospital
Division name
Rehabilitation department
Zip code
305-8576
Address
2-1-1 Amakubo, Tsukuba City, Ibaraki Prefecture
TEL
029-853-3795
Homepage URL
tsubaki2308@gmail.com
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
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
Tsukuba Clinical Research & Development Organization
Address
2-1-1 Amakubo, Tsukuba City, Ibaraki Prefecture
Tel
029-853-3914
t-credo.adm@un.tsukuba.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 01 | 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
| 2022 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | 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
| 2022 | Year | 06 | Month | 30 | Day |
Last modified on
| 2023 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054944
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
