UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060859 |
|---|---|
| Receipt number | R000066836 |
| Scientific Title | Examination of changes in balance and attention function by implementing sensor games in day care service users |
| Date of disclosure of the study information | 2026/03/06 |
| Last modified on | 2026/03/06 22:31:27 |
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Basic information
Public title
Examination of changes in balance and attention function by implementing sensor games in day care service users
Acronym
Examination of changes in balance and attention function by implementing sensor games in day care service users
Scientific Title
Examination of changes in balance and attention function by implementing sensor games in day care service users
Scientific Title:Acronym
Examination of changes in balance and attention function by implementing sensor games in day care service users
Region
| Japan |
Condition
Condition
Day service users aged 65 or older
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study targets day service users and aims to clarify whether there is a difference in effectiveness between supervised interaction by non-rehabilitation professionals using sensor games and regular rehabilitation intervention by rehabilitation professionals.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Mini-BESTest scores at two time points, at the beginning and end of the 4-week intervention
Key secondary outcomes
Berg Balance Scale (BBS) scores at two time points, at the beginning and end of the 4-week intervention
Timed UP and Go test (TUG) scores at two time points, at the beginning and end of the 4-week intervention
Trail Making Test (TMT) scores at two time points, at the beginning and end of the 4-week intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
sensor games
Interventions/Control_2
sensor games
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
| 45 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Ages 45 to 80 at the time of consent
2. Currently attending day care services
3. Individuals who agreed to participate in this study
Key exclusion criteria
1. Those who have difficulty with verbal communication
2. Those who have previously participated in digital rehabilitation sensor games at least four times per month
3. Those who achieved perfect scores on the Mini-BEST test and Berg balance scale before intervention
4. Those who have difficulty walking and cannot perform the Timed Up and Go test
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Yasuaki |
| Middle name | |
| Last name | Kusumoto |
Organization
Fukushima Medical University School of Health Sciences
Division name
Department of Physical Therapy
Zip code
960-8516
Address
10-6 Sakaemachi, Fukushima city, Fukushima
TEL
0245815503
kusumoto@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Yasuaki |
| Middle name | |
| Last name | Kusumoto |
Organization
Fukushima Medical University School of Health Sciences
Division name
Department of Physical Therapy
Zip code
960-8516
Address
10-6 Sakaemachi, Fukushima city, Fukushima
TEL
0245815503
Homepage URL
kusumoto@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University School of Health Sciences
Institute
Department
Personal name
Kusumoto Yasuaki
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima Medical University Ethics Review Committee
Address
Hikarigaoka 1, Fukushima City, Fukushima Prefecture
Tel
0245471825
fmurec@fmu.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
| 2026 | Year | 03 | Month | 06 | 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
| 2025 | Year | 07 | Month | 18 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 18 | 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
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 06 | Day |
Last modified on
| 2026 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000066836
