UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061799 |
|---|---|
| Receipt number | R000070716 |
| Scientific Title | Effect of Gaze Stability Exercises on Balance Function in Older Adults During Acute Hospitalization: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/06/05 |
| Last modified on | 2026/06/04 18:08:44 |
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Basic information
Public title
Effect of Gaze Stability Exercises on Balance Function in Older Adults During Acute Hospitalization: A Randomized Controlled Trial
Acronym
Gaze Stabilization and Balance in Acute Older Adults
Scientific Title
Effect of Gaze Stability Exercises on Balance Function in Older Adults During Acute Hospitalization: A Randomized Controlled Trial
Scientific Title:Acronym
Gaze Stabilization and Balance in Acute Older Adults
Region
| Japan |
Condition
Condition
Elderly patients aged 65 and older who are hospitalized: disuse syndrome
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether incorporating gaze stability exercises (GSE), a vestibular rehabilitation approach, into conventional physical therapy during acute hospitalization improves balance function in older adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Berg Balance Scale (BBS), Dynamic Gait Index (DGI), and Timed Up and Go test (TUG)
Key secondary outcomes
Sub-items of the Berg Balance Scale (BBS) and the Dynamic Gait Index (DGI)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
30 minutes of standard physical therapy plus 10 minutes of GSE
Interventions were delivered physical therapy five days a week for 40 minutes per day.
Interventions/Control_2
40 minutes of standard physical therapy alone
Interventions were delivered physical therapy five days a week for 40 minutes per day.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Eligible participants were adults aged 65 years or older who were admitted to an acute care hospital for acute medical conditions and received physical therapy during hospitalization. Participants who met the eligibility criteria and provided written informed consent were enrolled in the study.
Key exclusion criteria
Inability to follow simple commands; requirement for physical assistance during ambulation (use of a walking aid was permitted); use of medications that may affect balance or vestibular function; and medical conditions or histories likely to affect balance or vestibular function.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yuina |
| Middle name | |
| Last name | Sano |
Organization
Fujinomiya City General Hospital
Division name
Department of Rehabilitation
Zip code
4180076
Address
3-1 Nishiki-cho, Fujinomiya City, Shizuoka Prefecture
TEL
0544-27-3151
yuina.sano@outlook.jp
Public contact
Name of contact person
| 1st name | Yuina |
| Middle name | |
| Last name | Sano |
Organization
Fujinomiya City General Hospital
Division name
Department of Rehabilitation
Zip code
418-0076
Address
3-1 Nishiki-cho, Fujinomiya City, Shizuoka Prefecture
TEL
0544-27-3151
Homepage URL
yuina.sano@outlook.jp
Sponsor or person
Institute
Fujinomiya City General Hospital
Institute
Department
Personal name
Funding Source
Organization
No
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujinomiya City General Hospital
Address
3-1 Nishiki-cho, Fujinomiya City, Shizuoka Prefecture
Tel
0544-27-3151
yuina.sano@outlook.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 | 06 | Month | 05 | Day |
Related information
URL releasing protocol
NA
Publication of results
Unpublished
Result
URL related to results and publications
NA
Number of participants that the trial has enrolled
60
Results
Unpublished
Results date posted
| 2026 | Year | 06 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Unpublished
Participant flow
Unpublished
Adverse events
Unpublished
Outcome measures
Unpublished
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 04 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study was conducted prior to the clinical trial registration, and this registration is a retrospective one.
Management information
Registered date
| 2026 | Year | 06 | Month | 04 | Day |
Last modified on
| 2026 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070716
