BalanceNCT05779189
Effects of Game-based Virtual Reality Intervention on Senior Fitness, Fall Prevention and Balance Function Among Older Adults
A study testing Game-based virtual reality (Game) and Conventional health education in people with Balance, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
The purpose of this study is to explore the effectiveness between game-based virtual reality intervention and conventional health education in improving older adults' balance knowledge, and let them know how to prevent falling. Read more about this study
- Who is it for?
- Ages 65 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Balance
- What is being tested?
- Game-based virtual reality (Game) and Conventional health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Sep 2022to 3 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 99 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Elderly people over the age of 65-99.
Who cannot join
- cognitive impairment
- neurological diseases
- severe osteoporosis
- lower limb joint surgery
- discomfort symptoms during exercise
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to explore the effectiveness between game-based virtual reality intervention and conventional health education in improving older adults' balance knowledge, and let them know how to prevent falling. The intervention group will receive virtual reality games in person and read the health education flier, while the control group was assigned to read the health education flier and follow suit the video of balance exercise.
Read the detailed description
Falls can lead to disability, sickbed and even death of the elderly, and it ranks second among the top ten which causes death in Taiwan. In the past, when multifaceted exercise interventions were conducted for the elderly, most of them focused on group strength training and aerobic exercise, but lacked individualized balance training, resulting in a low degree of cooperation.
- Conditions
- Balance
- Being tested
- Game-based virtual reality (Game), Conventional health education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Game-based virtual reality (Game)Behavioural
Besides reading the health education flier, they also need to trained with the game-based virtual reality in Biodex Medical Systems, which is a machine, includes 4 games: Catch Game, boating, Ball Maze, and Word Search. And all of the games are balance control games. The games were implemented in person for 30 minutes one time, total is 16 times (once to twice day a week).
Conventional health educationBehavioural
The health education flier was made refer to medical institutions, e.g., hospitals or clinics, the video of balance exercise was collected from the internet. Participants were assigned to read the health education flier, and follow suit the video of balance exercise at home of their free will.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants will receive conventional health education and game-based virtual reality (game) in person. Receives: Behavioral: Game-based virtual reality (Game) |
| Control | Active comparator | Participants will receive conventional health education and 4 video of balance exercise. Receives: Behavioral: Conventional health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Senior Fitness Test
Participants were assigned to do 2 tasks of the test. One is time up and go, and the other one is eyes-open single-leg stance test. We recorded the time (in seconds) they took.
Measured: Right after the intervention
Falls Efficacy Scale International
Participants were assessed by the questionnaire, and we recorded the points of the participants. The higher the point is, the more concerned they are about the falls.
Measured: Right after the intervention
Balance or sensory-Integration test
The balance of postural-stability test and the modified clinical test of sensory integration and balance (m-CTSIB) were performed using the Biodex Stability System (BSS; Biodex Medical Systems, Shirley, New York, USA).
Measured: Right after the intervention
Balance of postural-stability test
The balance of postural stability was tested according to 3 stability indices (overall stability; anterior-to-posterior stability; and medial-to-lateral stability).
Measured: Right after the intervention
Modified Clinical Test for Sensory Integration of Balance (m-CTSIB)
The m-CTSIB, which includes 4 sway indices, was conducted 4 sensory conditions: (1) eyes open whilst standing on a firm surface (EOFIS); (2) eyes closed whilst standing on a firm surface (ECFIS): (3) eves open whilst standing on an unstable (foam) surface (EOFOS); and (4) eyes closed whilst standing on an unstable (foam) surface (ECFOS).
Measured: Right after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start15 Sep 2022
- Primary completion15 Jan 2023
- Study completion3 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BalanceStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05779189
- Sponsor's protocol ID
- N202204048
- Status last verified
- May 2022
- First submitted
- 3 Mar 2023
- Last updated
- 22 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Huang CJ, Chen HC, Oknina L, Huang SW, Lin LF. Effects of game-based virtual reality balance training on postural stability and mobility in community-dwelling older adults: an exploratory randomized controlled trial. BMC Geriatr. 2026 Jul 3. doi: 10.1186/s12877-026-07914-9. Online ahead of print.
PubMed 42393561
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Game-based Virtual Reality Intervention on Senior Fitness, Fall Prevention and Balance Function Among Older Adults
- ClinicalTrials.gov ID
- NCT05779189
- Acronym / sponsor ID
- N202204048
- Conditions
- Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 3 Mar 2023 (actual)
- First posted
- 22 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to explore the effectiveness between game-based virtual reality intervention and conventional health education in improving older adults' balance knowledge, and let them know how to prevent falling. The intervention group will receive virtual reality games in person and read the health education flier, while the control group was assigned to read the health education flier and follow suit the video of balance exercise.
Detailed description
Falls can lead to disability, sickbed and even death of the elderly, and it ranks second among the top ten which causes death in Taiwan. In the past, when multifaceted exercise interventions were conducted for the elderly, most of them focused on group strength training and aerobic exercise, but lacked individualized balance training, resulting in a low degree of cooperation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Game-based virtual reality (Game)Participants will receive conventional health education and game-based virtual reality (game) in person. |
| Control | Active comparator | Behavioral: Conventional health educationParticipants will receive conventional health education and 4 video of balance exercise. |
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Elderly people over the age of 65-99.
Key exclusion criteria (5 listed)
- cognitive impairment
- neurological diseases
- severe osteoporosis
- lower limb joint surgery
- discomfort symptoms during exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Game-based virtual reality (Game)Besides reading the health education flier, they also need to trained with the game-based virtual reality in Biodex Medical Systems, which is a machine, includes 4 games: Catch Game, boating, Ball Maze, and Word Search. And all of the games are balance control games. The games were implemented in person for 30 minutes one time, total is 16 times (once to twice day a week). | Behavioural | Intervention |
| Conventional health educationThe health education flier was made refer to medical institutions, e.g., hospitals or clinics, the video of balance exercise was collected from the internet. Participants were assigned to read the health education flier, and follow suit the video of balance exercise at home of their free will. | Behavioural | Control |
Primary outcome
Senior Fitness Test
Time frame: Right after the intervention
Participants were assigned to do 2 tasks of the test. One is time up and go, and the other one is eyes-open single-leg stance test. We recorded the time (in seconds) they took.
Falls Efficacy Scale International
Time frame: Right after the intervention
Participants were assessed by the questionnaire, and we recorded the points of the participants. The higher the point is, the more concerned they are about the falls.
Balance or sensory-Integration test
Time frame: Right after the intervention
The balance of postural-stability test and the modified clinical test of sensory integration and balance (m-CTSIB) were performed using the Biodex Stability System (BSS; Biodex Medical Systems, Shirley, New York, USA).
Balance of postural-stability test
Time frame: Right after the intervention
The balance of postural stability was tested according to 3 stability indices (overall stability; anterior-to-posterior stability; and medial-to-lateral stability).
Modified Clinical Test for Sensory Integration of Balance (m-CTSIB)
Time frame: Right after the intervention
The m-CTSIB, which includes 4 sway indices, was conducted 4 sensory conditions: (1) eyes open whilst standing on a firm surface (EOFIS); (2) eyes closed whilst standing on a firm surface (ECFIS): (3) eves open whilst standing on an unstable (foam) surface (EOFOS); and (4) eyes closed whilst standing on an unstable (foam) surface (ECFOS).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Derived from this study: PubMed 42393561Huang CJ, Chen HC, Oknina L, Huang SW, Lin LF. Effects of game-based virtual reality balance training on postural stability and mobility in community-dwelling older adults: an exploratory randomized controlled trial. BMC Geriatr. 2026 Jul 3. doi: 10.1186/s12877-026-07914-9. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Game-based virtual reality (Game) and Conventional health education in people with Balance, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Senior Fitness Test (time frame: Right after the intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05779189, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023.