Virtual RealityNCT06539065
The Effects of VR Interactive Games on Balance and Quality of Life Enhancement for Elderly in the Community
A study testing VR interactive games in people with Virtual Reality, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
The goal of this clinical trial is to learn about the effectiveness of the incorporating VR interactive games into exercise courses of the elderly in the community.The main questions It aims to answer are: can It improve their balance ability and the quality of life. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality
- What is being tested?
- VR interactive games
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Feb 2023to 15 Jun 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 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Aged 65 or above
- Capable of communicating in Mandarin or Taiwanese, and willing to participate in interviews or complete questionnaires
- Free of mobility impairments
Who cannot join
- Stroke with sequelae of mobility impairments
- Parkinson's disease
- Motor neurone disease
- Severe Cardio-vascular disease
- Degenerative joint disease with flare-ups in past three months
- With a lower limb joint surgery in past 3 months
- Vertigo
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to learn about the effectiveness of the incorporating VR interactive games into exercise courses of the elderly in the community.The main questions It aims to answer are: can It improve their balance ability and the quality of life.
Participants will receive a Twelve-week intervention of 36 sessions using VR interactive games in their exercise prescription, While the control group will follow the original iInstructor-led exercise intervention as the course content.
Read the detailed description
Both groups will undergo three sessions per week, one hour per session, for a total of 12 weeks and 36 sessions of intervention. Before and after competing all sessions, the effectiveness of this intervention will be assessed.
Some physical assessments will be done by all participants such as 2-minute step, right chair sit and reach, left chair sit and reach to compare if any difference between two groups. and participants will do a questionaire to evaluate the psychological and environmental quality of life.
- Conditions
- Virtual Reality
- Being tested
- VR interactive games
- Keywords
- VR, Balance, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR interactive gamesDevice
The experimental group received a twelve-week intervention of 36 sessions using VR interactive games in their exercise prescription,
| Study group | Role | What they receive |
|---|---|---|
| VR group | Experimental | The experimental group received a twelve-week intervention of 36 sessions using VR interactive games in their exercise prescription Receives: Device: VR interactive games |
| Non-VR group | No intervention | control group followed the original instructor-led exercise intervention as the course content. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance ability
The scores of five physical assessments
Measured: Physical assessment done 2 weeks before and 2 weeks after 12 weeks courses
Life quality
The score of questionnaire done by all participants
Measured: Questionnaire done 2 weeks before and 2 weeks after 12 weeks courses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start13 Feb 2023
- Primary completion5 Jun 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chueh-Ho Lin, PhD, Study chair, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06539065
- Sponsor's protocol ID
- N202210004
- Status last verified
- Jun 2023
- First submitted
- 29 Jun 2023
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the datasets generated in this study are available from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of VR Interactive Games on Balance and Quality of Life Enhancement for Elderly in the Community
- ClinicalTrials.gov ID
- NCT06539065
- Acronym / sponsor ID
- N202210004
- Conditions
- Virtual Reality
- Keywords
- VR, Balance, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- 5 Jun 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 6 Aug 2024 (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 goal of this clinical trial is to learn about the effectiveness of the incorporating VR interactive games into exercise courses of the elderly in the community.The main questions It aims to answer are: can It improve their balance ability and the quality of life.
Participants will receive a Twelve-week intervention of 36 sessions using VR interactive games in their exercise prescription, While the control group will follow the original iInstructor-led exercise intervention as the course content.
Detailed description
Both groups will undergo three sessions per week, one hour per session, for a total of 12 weeks and 36 sessions of intervention. Before and after competing all sessions, the effectiveness of this intervention will be assessed.
Some physical assessments will be done by all participants such as 2-minute step, right chair sit and reach, left chair sit and reach to compare if any difference between two groups. and participants will do a questionaire to evaluate the psychological and environmental quality of life.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR group | Experimental | Device: VR interactive gamesThe experimental group received a twelve-week intervention of 36 sessions using VR interactive games in their exercise prescription |
| Non-VR group | No intervention | –control group followed the original instructor-led exercise intervention as the course content. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Aged 65 or above
- Capable of communicating in Mandarin or Taiwanese, and willing to participate in interviews or complete questionnaires
- Free of mobility impairments
Key exclusion criteria (7 listed)
- Stroke with sequelae of mobility impairments
- Parkinson's disease
- Motor neurone disease
- Severe Cardio-vascular disease
- Degenerative joint disease with flare-ups in past three months
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 |
|---|---|---|
| VR interactive gamesThe experimental group received a twelve-week intervention of 36 sessions using VR interactive games in their exercise prescription, | Device | VR group |
Primary outcome
Balance ability
Time frame: Physical assessment done 2 weeks before and 2 weeks after 12 weeks courses
The scores of five physical assessments
Life quality
Time frame: Questionnaire done 2 weeks before and 2 weeks after 12 weeks courses
The score of questionnaire done by all participants
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 6 Aug 2024.
- Individual participant dataSharing planned: Yes. the datasets generated in this study are available from the corresponding author upon reasonable request.
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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.
Chueh-Ho Lin, PhD study chair
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR interactive games in people with Virtual Reality, 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 3 inclusion and 7 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 6 Aug 2024. 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?
Balance ability (time frame: Physical assessment done 2 weeks before and 2 weeks after 12 weeks courses). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2024.