UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050452 |
|---|---|
| Receipt number | R000057455 |
| Scientific Title | Immediate effects of full-body exercise using virtual reality on balance performance. |
| Date of disclosure of the study information | 2023/03/01 |
| Last modified on | 2026/09/02 17:55:33 |
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Basic information
Public title
Immediate effects of full-body exercise using virtual reality on balance performance.
Acronym
Immediate effects of full-body exercise using virtual reality on balance performance.
Scientific Title
Immediate effects of full-body exercise using virtual reality on balance performance.
Scientific Title:Acronym
Immediate effects of full-body exercise using virtual reality on balance performance.
Region
| Japan |
Condition
Condition
Neurological diseases, healthy elderly
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the immediate effect and feasibility of full-body exercise using virtual reality on balance performance in neurological diseases and healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Timed Up & Go Test
Key secondary outcomes
1. Berg Balance Scale
2. Functional Reach Test
3. 10-m Walk Test
4. Simulator Sickness Questionnaire
5. Numerical Rating Scale (enjoyability, continuation, effectiveness, fatigue)
6. Kinematic parameters and heart rate during exercise
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The full-body exercise using virtual reality for 20-40 minutes (1 session)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Neurological disease
1. Participants who consulted a rehabilitation department
2. Consent to participate in this study
Healthy elderly
1. No history of diseases that may affect this study
2. Consent to participate in this study
Key exclusion criteria
1. Cognitive dysfunction (Mini Mental State Examination < 23)
2. Unable to stand independently
3. Severe visual impairment
4. Orthopedic disorders or rheumatoid arthritis that result in exercise limitation
5. Lower back pain or Lower limb pain that result in exercise limitation
6. Vestibular disorder or history of seizures
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Otaka |
Organization
Fujita Health University
Division name
Department of Rehabilitation Medicine I, School of Medicine
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi, Japan
TEL
0562-93-2167
rehabmed@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Ushizawa |
Organization
Fujita Health University
Division name
Department of Rehabilitation Medicine I, School of Medicine
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi, Japan
TEL
0562-93-2167
Homepage URL
kazuki.ushizawa@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
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
Institutional Review Board of Fujita Health University
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
Tel
0562-93-2865
f-irb@fujita-hu.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
| 2023 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S2590109526000534?via%3Dihub
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S2590109526000534?via%3Dihub
Number of participants that the trial has enrolled
31
Results
The median SSQ-nausea, SSQ-oculomotor, SSQ-disorientation, and SSQ-total scores were 9.5, 7.6, 0.0, and 7.5, respectively, indicating a low likelihood of simulator sickness. The median Numerical Rating Scale scores for enjoyment, continuation, effectiveness, and fatigue were 8.0, 8.0, 7.5, and 2.0, respectively. The Timed Up and Go test inindividuals with stroke and Functional Reach Test in older adults showed significant improvement after exercise (P<.05).
Results date posted
| 2026 | Year | 09 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Thirty-one participants were enrolled between April 2023 and July 2024, including 10 community-dwelling older adults (4 women; mean age, 70.4 y; SD, 3.0), 11 individuals with Parkinson's disease (4 women; mean age, 68.4 y; SD, 7.6), and 10 with stroke (3 women; mean age, 62.8 y; SD, 16.2). All participants with Parkinson's disease and stroke were able to walk with or without supervison.
Participant flow
Older adults were recruited from non-medical hospital workers and the community-dwelling older adults, who were naive to the purpose of the study through posters displayed in university and hospital facilities and leaflets distributed by the research team. Participants with Parkinson's disease and stroke were recruited from the Department of Neurology and the Department of Rehablititation Medicine at Fujita Health University Hospital. Then, all participants performed a single 20-minute session of MR-based dynamic exercises.
Adverse events
No adverse events were reported during the exercise.
Outcome measures
(1) Simulator Sickness Questionnaire
(2) Numerical Rating Scale (levels of enjoyment, perceived potential for continued use, perceived effectiveness, and fatigue)
(3) Timed Up and Go test
(4) Functional Reach Test
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 28 | Day |
Last modified on
| 2026 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057455
