UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058766 |
|---|---|
| Receipt number | R000067195 |
| Scientific Title | The relationship between mobility support using application tools and self-efficacy for people with visuospatial cognitive impairment: A randomized controlled trial |
| Date of disclosure of the study information | 2025/09/01 |
| Last modified on | 2025/08/12 11:25:41 |
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Basic information
Public title
The relationship between mobility support using application tools and self-efficacy for people with visuospatial cognitive impairment: A randomized controlled trial
Acronym
Mobility support using application tools for people with visual-spatial cognitive impairment
Scientific Title
The relationship between mobility support using application tools and self-efficacy for people with visuospatial cognitive impairment: A randomized controlled trial
Scientific Title:Acronym
The relationship between mobility support using application tools and self-efficacy for people with visuospatial cognitive impairmen
Region
| Japan |
Condition
Condition
Cognitive impairment after brain injury
Classification by specialty
| Neurology | Psychiatry | Neurosurgery |
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether the use of the LOOVIC application tool contributes to improving self-efficacy in community residents with visuospatial cognitive impairment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Self-efficacy: General Self-Efficacy Scale (GSES)
Quality of life: EQ-5D-5L
Mental health: K6
Living space: Life space assessment (LSA)
Number of outings and falls (recorded daily by participants)
Satisfaction and performance regarding outings: Canadian Activities of Daily Living Scale
The above items will be assessed at baseline, 4 weeks (post-intervention), 12 weeks (follow-up), and 24 weeks (follow-up).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Intervention period: 4 weeks
Follow-up period: 3 months later, 6 months later
Blinding: Single-blind
Intervention group: Outdoor support using the LOOVIC application tool
Each period consisted of one 40-minute intervention session per week.
Interventions/Control_2
Intervention period: 4 weeks
Follow-up period: 3 months later, 6 months later
Blinding: Single-blind
Control group: Regular outdoor support (therapist provides guidance)
Each period consisted of one 40-minute intervention session per week.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Individuals with visuospatial cognitive impairment due to brain damage
Aged 20 to 79
Individuals living at home with a clear level of consciousness and an MMSE-J score of 24 or higher
Individuals who can walk outdoors independently
Individuals who can give their consent to participate in the study
Key exclusion criteria
Those under 20 years of age or over 80 years of age
Those with a history of dementia or mental illness
Those who live alone
Those with severe aphasia who have difficulty understanding the questionnaire
Those with apraxia
Those with hearing abnormalities (hearing loss, deafness, etc.)
Those who cannot give their consent to participate in the study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Miyauchi |
Organization
Shonan University of Medical Sciences
Division name
Department of Rehabilitation, Faculty of Medical Sciences
Zip code
244-0806
Address
16-48, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL
045-821-0111
takayuki.miyauchi@sums.ac.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Miyauchi |
Organization
Shonan University of Medical Sciences
Division name
Faculty of Medical Sciences
Zip code
244-0806
Address
16-48, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL
045-821-0111
Homepage URL
takayuki.miyauchi@sums.ac.jp
Sponsor or person
Institute
Shonan University of Medical Sciences
Institute
Department
Personal name
Takayuki Miyauchi
Funding Source
Organization
sself-supply
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Naya Clinic, Clubhouse Step Nana, LOOVIC Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shonan University of Medical Sciences
Address
16-48, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
Tel
045-821-0111
takayuki.miyauchi@sums.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
Kanagawa
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2028 | 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
| 2025 | Year | 08 | Month | 12 | Day |
Last modified on
| 2025 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067195
