Disease PreventionNCT07088848
Gamified Digital Balance Assessment
A study testing Gamified Digital Balance Assessment and Digitalized Brief-BESTest design in people with Disease Prevention, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
A randomized controlled trial involving 30 older adults will compare the digitalized Brief-BESTest and the GDBA. Quantitative outcomes included perceived exertion, enjoyment, competence, pressure, and intention to continue use. Qualitative interviews explore user experience. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Disease Prevention
- What is being tested?
- Gamified Digital Balance Assessment and Digitalized Brief-BESTest design
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2025to 20 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 60 or older, living independently, able to walk with or without an assistive device (without external help), willing and able to provide informed consent.
Who cannot join
- conditions that impede walking (e.g., hip fractures, lower limb amputations, hemiparesis), medications causing dizziness or affecting balance (e.g., psychotropic drugs), self-reported cardiovascular, pulmonary, neurological, musculoskeletal, or mental disorders, severe fatigue or pain, severe uncorrected vision or hearing impairments that may affect their ability to interact with the digital system
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Effectiveness of a Gamification in Balance Assessment Tools
A randomized controlled trial involving 30 older adults will compare the digitalized Brief-BESTest and the GDBA. Quantitative outcomes included perceived exertion, enjoyment, competence, pressure, and intention to continue use. Qualitative interviews explore user experience.
- Conditions
- Disease Prevention
- Being tested
- Gamified Digital Balance Assessment, Digitalized Brief-BESTest design
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamified Digital Balance AssessmentDevice
The GDBA further enhances the digitalized Brief-BESTest experience by incorporating gamification elements tailored to older adults, including points, avatars, real-time performance graphs, and leaderboards. The system provides automated feedback and maintains engagement through periodic avatar demonstrations when user inactivity is detected. Upon meeting task initiation criteria, a countdown triggers data capture.
The interface is designed for accessibility, featuring a high-contrast color scheme (black background with orange/green highlights), voice prompts, and intuitive controls. Upon completion, users receive a comprehensive report including total score, task-level feedback and training recommendations. A leaderboard feature promotes continued engagement, with gamified training modules under development.
At the end of the assessment, the system displays a summary including total balance score, task-specific feedback, a fall risk rating, and personalized training suggestions. Users
Digitalized Brief-BESTest designDevice
The digitalized Brief-BESTest was designed to digitize and automate the Brief-BESTest. While the traditional clinician-administered Brief-BESTest relies on subjective scoring, the digitalized Brief-BESTest enables self-guided assessments with automated, objective scoring-improving accessibility in community and home settings.
The system employs OpenPose to capture skeletal data via a standard 2D camera, tracking 17 anatomical landmarks (e.g., nose, neck, shoulders, hips, knees). Ten joint angles relevant to static and dynamic postural tasks (e.g., standing, sitting, single-leg stance, and simulated falls) are computed. The torso is defined as a vector from the neck to the midpoint between the hips, serving as a reference for postural alignment.
To convert pixel-based coordinates into metric units, the system uses the user's self-reported height with adjustments based on ISO anthropometric standards (correction factors: 10.77 cm for males, 10.06 cm for females) to approximate true body
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | The digitalized Brief-BESTest was designed to digitize and automate the Brief-BESTest. While the traditional clinician-administered Brief-BESTest relies on subjective scoring, the digitalized Brief-BESTest enables self-guided assessments with automated, objective scoring-improving accessibility in community and home settings. Receives: Device: Gamified Digital Balance Assessment |
| Experimental group | Experimental | The GDBA further enhances the digitalized Brief-BESTest experience by incorporating gamification elements tailored to older adults, including points, avatars, real-time performance graphs, and leaderboards. The system provides automated feedback and maintains engagement through periodic avatar demonstrations when user inactivity is detected. Upon meeting task initiation criteria, a countdown triggers data capture. Receives: Device: Digitalized Brief-BESTest design |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance Performance:
Balance ability was assessed using the digitalized Brief-BESTest
Measured: Through intervention completion, an average of 10 mins
Secondary outcomes (1)
Fatigue level
Motivational engagement was evaluated using the Intrinsic Motivation Inventory (IMI)
Measured: Through intervention completion, an average of 10 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start20 Apr 2025
- Primary completion10 Aug 2025 (estimated)
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disease PreventionStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianan Zhao, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07088848
- Sponsor's protocol ID
- gamification in balance test
- Other IDs
- School
- Status last verified
- Jul 2025
- First submitted
- 19 Jul 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Information might be shared after publication.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of a Gamification in Balance Assessment Tools
- ClinicalTrials.gov ID
- NCT07088848
- Acronym / sponsor ID
- gamification in balance test
- Conditions
- Disease Prevention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 20 Apr 2025 (actual)
- Primary completion
- 10 Aug 2025 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 28 Jul 2025 (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.
A randomized controlled trial involving 30 older adults will compare the digitalized Brief-BESTest and the GDBA. Quantitative outcomes included perceived exertion, enjoyment, competence, pressure, and intention to continue use. Qualitative interviews explore user experience.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Device: Gamified Digital Balance AssessmentThe digitalized Brief-BESTest was designed to digitize and automate the Brief-BESTest. While the traditional clinician-administered Brief-BESTest relies on subjective scoring, the digitalized Brief-BESTest enables self-guided assessments with automated, objective scoring-improving accessibility in community and home settings. |
| Experimental group | Experimental | Device: Digitalized Brief-BESTest designThe GDBA further enhances the digitalized Brief-BESTest experience by incorporating gamification elements tailored to older adults, including points, avatars, real-time performance graphs, and leaderboards. The system provides automated feedback and maintains engagement through periodic avatar demonstrations when user inactivity is detected. Upon meeting task initiation criteria, a countdown triggers data capture. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- aged 60 or older, living independently, able to walk with or without an assistive device (without external help), willing and able to provide informed consent.
Key exclusion criteria (1 listed)
- conditions that impede walking (e.g., hip fractures, lower limb amputations, hemiparesis), medications causing dizziness or affecting balance (e.g., psychotropic drugs), self-reported cardiovascular, pulmonary, neurological, musculoskeletal, or mental disorders, severe fatigue or pain, severe uncorrected vision or hearing impairments that may affect their ability to interact with the digital system
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 |
|---|---|---|
| Gamified Digital Balance AssessmentThe GDBA further enhances the digitalized Brief-BESTest experience by incorporating gamification elements tailored to older adults, including points, avatars, real-time performance graphs, and leaderboards. The system provides automated feedback and maintains engagement through periodic avatar demonstrations when user inactivity is detected. Upon meeting task initiation criteria, a countdown triggers data capture. The interface is designed for accessibility, featuring a high-contrast color scheme (black background with orange/green highlights), voice prompts, and intuitive controls. Upon completion, users receive a comprehensive report including total score, task-level feedback and training recommendations. A leaderboard feature promotes continued engagement, with gamified training modules under development. At the end of the assessment, the system displays a summary including total balance score, task-specific feedback, a fall risk rating, and personalized training suggestions. Users | Device | Control group |
| Digitalized Brief-BESTest designThe digitalized Brief-BESTest was designed to digitize and automate the Brief-BESTest. While the traditional clinician-administered Brief-BESTest relies on subjective scoring, the digitalized Brief-BESTest enables self-guided assessments with automated, objective scoring-improving accessibility in community and home settings. The system employs OpenPose to capture skeletal data via a standard 2D camera, tracking 17 anatomical landmarks (e.g., nose, neck, shoulders, hips, knees). Ten joint angles relevant to static and dynamic postural tasks (e.g., standing, sitting, single-leg stance, and simulated falls) are computed. The torso is defined as a vector from the neck to the midpoint between the hips, serving as a reference for postural alignment. To convert pixel-based coordinates into metric units, the system uses the user's self-reported height with adjustments based on ISO anthropometric standards (correction factors: 10.77 cm for males, 10.06 cm for females) to approximate true body | Device | Experimental group |
Primary outcome
Balance Performance:
Time frame: Through intervention completion, an average of 10 mins
Balance ability was assessed using the digitalized Brief-BESTest
1 secondary outcome
Fatigue level
Time frame: Through intervention completion, an average of 10 mins
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Individual participant dataSharing planned: Undecided. Information might be shared after publication.
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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 Gamified Digital Balance Assessment and Digitalized Brief-BESTest design in people with Disease Prevention, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 1 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: under way, not looking for participants, as of the sponsor's last update on 28 Jul 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
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 Performance: (time frame: Through intervention completion, an average of 10 mins). 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 28 Jul 2025.