ELDERLY PEOPLENCT06958653
Gamified Digital Balance Assessment for Older Adults in Community Settings: Development, Validation, and User Experience Evaluation in a Mixed Methods Study
A study testing Brief-BESTest assessment, Digital balance assessment tool and Gamified Digital Balance Assessment (GDBA) in people with ELDERLY PEOPLE and Fall Prevention, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The study was conducted in two sequential phases to evaluate the reliability and user experience of a GBDA tailored for community-dwelling older adults. Phase 1: Reliability of digitalized Brief-BESTest assessment In the first phase, participants performed a single balance assessment session, during which both the… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- ELDERLY PEOPLE, Fall Prevention, Digital Health
- What is being tested?
- Brief-BESTest assessment, Digital balance assessment tool and Gamified Digital Balance Assessment (GDBA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2025to 20 Sep 2025
- 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 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
The study was conducted in two sequential phases to evaluate the reliability and user experience of a GBDA tailored for community-dwelling older adults.
Phase 1: Reliability of digitalized Brief-BESTest assessment In the first phase, participants performed a single balance assessment session, during which both the clinician-administered Brief-BESTest and the digitalized Brief-BESTest were scored concurrently. This approach enabled direct comparison between clinical and automated assessments under identical task conditions.
Read more
Testing was conducted in a controlled indoor setting featuring a 1 m × 1 m, 10 cm-thick EVA foam mat (35D density) and safety handrails on three sides. Prior to the assessment, participants completed a baseline questionnaire collecting demographic data (age, sex), anthropometric measurements (height, weight), and fall history (past 12 months). Written informed consent was obtained from all participants.
During the assessment, a certified physical therapist delivered standardized verbal instructions and rated each task using the validated Brief-BESTest rubric (maximum score = 24). Simultaneously, the digitalized Brief-BESTest system recorded participants' movements using a monocular 4K camera and calculated scores via an algorithm that mirrors the original scoring criteria. The torso and joint movements were analyzed in real time, and balance scores were automatically computed.
To evaluate inter-rater reliability, a second trained clinician independently rated 20% of the sample. This concurrent scoring design ensured consistent task execution while enabling evaluation of inter-method reliability of the automated system's scoring against expert clinician judgment.
Phase 2: Impact of GBDA on User Experience The second phase involved a parallel group randomized controlled trial to assess the impact of gamification on user experience. Participants were randomly assigned (1:1) to either the control group (uses digitalized Brief-BESTest) or the experimental group (uses GDBA) through a simple coin-randomization method by a blinded researcher. Testing was conducted in a 1 m × 3 m evaluation zone equipped with front, side, and rear safety railings, and a centrally placed EVA foam pad (identical to Phase 1). The DBTS system included a display screen, a Logitech Brio 4K webcam (30 fps) for motion tracking, and a built-in speaker for voice prompts. A detachable, ergonomically designed user console-compliant with Chinese anthropometric standards-was mounted on the front railing for interface navigation (see Figure 2).
In the control group, participants performed balance tasks following pre-recorded verbal instructions from a certified physical therapist. In the experimental group, tasks were presented via the GDBA interface, which included animated avatars, voice guidance, progress indicators, and real-time performance feedback. Each participant completed one practice trial per task to minimize learning effects, followed by the formal assessment. A 2-minute seated rest period was provided between tasks to reduce fatigue.
Immediately following the assessment, participants completed self-report measures on perceived exertion, intrinsic motivation, and intention for continued use. They then participated in a brief semi-structured interview exploring their perceptions of system usability and engagement. All interviews were audio-recorded and transcribed for thematic analysis. Participants received a nominal compensation (USD $10 equivalent) upon study completion.
- Conditions
- ELDERLY PEOPLE, Fall Prevention, Digital Health
- Being tested
- Brief-BESTest assessment, Digital balance assessment tool, Gamified Digital Balance Assessment (GDBA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief-BESTest assessmentDevice
Uses the traditional Brief-BESTest to assess the balance ability of the participants.
Digital balance assessment toolDevice
Uses the digital balance assessment tool, which is the digitalized Brief-BESTest, to assess their balance ability.
Gamified Digital Balance Assessment (GDBA)Device
The GDBA builds upon the digitalized Brief-BESTest by incorporating evidence-based gamification elements designed to enhance motivation and engagement among older adults. The gamification design was guided by self-determination theory, which posits that autonomy, competence, and relatedness are key drivers of intrinsic motivation, and by recent systematic reviews on gamification for older adult health interventions.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Participants in the control group used Brief-BESTest to assess their balance ability Receives: Device: Brief-BESTest assessment |
| Experimental group | Active comparator | Participants in the experimental group uses the Gamified Digital Balance Assessment to assess their balance ability Receives: Device: Digital balance assessment tool |
| Gamified group | Experimental | The GDBA builds upon the digitalized Brief-BESTest by incorporating evidence-based gamification elements designed to enhance motivation and engagement among older adults. The gamification design was guided by self-determination theory, which posits that autonomy, competence, and relatedness are key drivers of intrinsic motivation, and by recent systematic reviews on gamification for older adult health interventions. Receives: Device: Gamified Digital Balance Assessment (GDBA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived physical exertion
Perceived physical exertion was measured using the Borg Rating of Perceived Exertion (RPE) Scale, ranging from 6 ("no exertion") to 20 ("maximal exertion"). Participants verbally reported their RPE immediately after completing all balance tasks to reflect overall physical demand and fatigue during the assessment. This measure provided insight into the tolerability and physical burden of the assessment procedures.
Measured: Through intervention completion, an average of 10 mins
Motivational engagement
Motivational engagement was evaluated using the Intrinsic Motivation Inventory (IMI), a validated tool employing a 7-point Likert scale (1 = "not at all true," 7 = "very true") . Three subscales were analyzed: Interest/Enjoyment (assesses task engagement and inherent enjoyment of the activity); Perceived Competence (measures self-perceived ability and confidence in performing the tasks); Pressure/Tension (evaluates task-related stress and anxiety). Subscale scores were calculated as the mean of item responses, with higher scores indicating greater enjoyment, competence, or pressure, respectively. The IMI has demonstrated good internal consistency and construct validity in older adult populations
Measured: Through intervention completion, an average of 10 mins
Intention to continue use
Intention to continue use was assessed through both quantitative and qualitative methods. Quantitatively, participants rated their likelihood of using the system again on a single-item 7-point Likert scale (1 = "very unlikely," 7 = "very likely") immediately following the assessment. Qualitatively, semi-structured interviews explored factors influencing future use intentions. Interview questions included: "Would you consider using this system regularly for balance checking? Why or why not?" and "What features would encourage you to use this system more often?" Interviews lasted 3-5 minutes, were audio-recorded with permission, transcribed verbatim, and analyzed using Braun and Clarke's six-phase thematic analysis framework.
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 posted6 May 2025
- Study start20 Apr 2025
- Primary completion20 May 2025
- Study completion20 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ELDERLY PEOPLEStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
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
- NCT06958653
- Sponsor's protocol ID
- Balance assessment tool
- Status last verified
- Jan 2024
- First submitted
- 17 Apr 2025
- Last updated
- 22 Jan 2026
- 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 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gamified Digital Balance Assessment for Older Adults in Community Settings: Development, Validation, and User Experience Evaluation in a Mixed Methods Study
- ClinicalTrials.gov ID
- NCT06958653
- Acronym / sponsor ID
- Balance assessment tool
- Conditions
- ELDERLY PEOPLE, Fall Prevention, Digital Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 20 Apr 2025 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 20 Sep 2025 (actual)
- First posted
- 6 May 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.
The study was conducted in two sequential phases to evaluate the reliability and user experience of a GBDA tailored for community-dwelling older adults.
Phase 1: Reliability of digitalized Brief-BESTest assessment In the first phase, participants performed a single balance assessment session, during which both the clinician-administered Brief-BESTest and the digitalized Brief-BESTest were scored concurrently. This approach enabled direct comparison between clinical and automated assessments under identical task conditions.
Testing was conducted in a controlled indoor setting featuring a 1 m × 1 m, 10 cm-thick EVA foam mat (35D density) and safety handrails on three sides. Prior to the assessment, participants completed a baseline questionnaire collecting demographic data (age, sex), anthropometric measurements (height, weight), and fall history (past 12 months). Written informed consent was obtained from all participants.
During the assessment, a certified physical therapist delivered standardized verbal instructions and rated each task using the validated Brief-BESTest rubric (maximum score = 24). Simultaneously, the digitalized Brief-BESTest system recorded participants' movements using a monocular 4K camera and calculated scores via an algorithm that mirrors the original scoring criteria. The torso and joint movements were analyzed in real time, and balance scores were automatically computed.
To evaluate inter-rater reliability, a second trained clinician independently rated 20% of the sample. This concurrent scoring design ensured consistent task execution while enabling evaluation of inter-method reliability of the automated system's scoring against expert clinician judgment.
Phase 2: Impact of GBDA on User Experience The second phase involved a parallel group randomized controlled trial to assess the impact of gamification on user experience. Participants were randomly assigned (1:1) to either the control group (uses digitalized Brief-BESTest) or the experimental group (uses GDBA) through a simple coin-randomization method by a blinded researcher. Testing was conducted in a 1 m × 3 m evaluation zone equipped with front, side, and rear safety railings, and a centrally placed EVA foam pad (identical to Phase 1). The DBTS system included a display screen, a Logitech Brio 4K webcam (30 fps) for motion tracking, and a built-in speaker for voice prompts. A detachable, ergonomically designed user console-compliant with Chinese anthropometric standards-was mounted on the front railing for interface navigation (see Figure 2).
In the control group, participants performed balance tasks following pre-recorded verbal instructions from a certified physical therapist. In the experimental group, tasks were presented via the GDBA interface, which included animated avatars, voice guidance, progress indicators, and real-time performance feedback. Each participant completed one practice trial per task to minimize learning effects, followed by the formal assessment. A 2-minute seated rest period was provided between tasks to reduce fatigue.
Immediately following the assessment, participants completed self-report measures on perceived exertion, intrinsic motivation, and intention for continued use. They then participated in a brief semi-structured interview exploring their perceptions of system usability and engagement. All interviews were audio-recorded and transcribed for thematic analysis. Participants received a nominal compensation (USD $10 equivalent) upon study completion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Device: Brief-BESTest assessmentParticipants in the control group used Brief-BESTest to assess their balance ability |
| Experimental group | Active comparator | Device: Digital balance assessment toolParticipants in the experimental group uses the Gamified Digital Balance Assessment to assess their balance ability |
| Gamified group | Experimental | Device: Gamified Digital Balance Assessment (GDBA)The GDBA builds upon the digitalized Brief-BESTest by incorporating evidence-based gamification elements designed to enhance motivation and engagement among older adults. The gamification design was guided by self-determination theory, which posits that autonomy, competence, and relatedness are key drivers of intrinsic motivation, and by recent systematic reviews on gamification for older adult health interventions. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 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 (5 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 |
|---|---|---|
| Brief-BESTest assessmentUses the traditional Brief-BESTest to assess the balance ability of the participants. | Device | Control group |
| Digital balance assessment toolUses the digital balance assessment tool, which is the digitalized Brief-BESTest, to assess their balance ability. | Device | Experimental group |
| Gamified Digital Balance Assessment (GDBA)The GDBA builds upon the digitalized Brief-BESTest by incorporating evidence-based gamification elements designed to enhance motivation and engagement among older adults. The gamification design was guided by self-determination theory, which posits that autonomy, competence, and relatedness are key drivers of intrinsic motivation, and by recent systematic reviews on gamification for older adult health interventions. | Device | Gamified group |
Primary outcome
Perceived physical exertion
Time frame: Through intervention completion, an average of 10 mins
Perceived physical exertion was measured using the Borg Rating of Perceived Exertion (RPE) Scale, ranging from 6 ("no exertion") to 20 ("maximal exertion"). Participants verbally reported their RPE immediately after completing all balance tasks to reflect overall physical demand and fatigue during the assessment. This measure provided insight into the tolerability and physical burden of the assessment procedures.
Motivational engagement
Time frame: Through intervention completion, an average of 10 mins
Motivational engagement was evaluated using the Intrinsic Motivation Inventory (IMI), a validated tool employing a 7-point Likert scale (1 = "not at all true," 7 = "very true") . Three subscales were analyzed: Interest/Enjoyment (assesses task engagement and inherent enjoyment of the activity); Perceived Competence (measures self-perceived ability and confidence in performing the tasks); Pressure/Tension (evaluates task-related stress and anxiety). Subscale scores were calculated as the mean of item responses, with higher scores indicating greater enjoyment, competence, or pressure, respectively. The IMI has demonstrated good internal consistency and construct validity in older adult populations
Intention to continue use
Time frame: Through intervention completion, an average of 10 mins
Intention to continue use was assessed through both quantitative and qualitative methods. Quantitatively, participants rated their likelihood of using the system again on a single-item 7-point Likert scale (1 = "very unlikely," 7 = "very likely") immediately following the assessment. Qualitatively, semi-structured interviews explored factors influencing future use intentions. Interview questions included: "Would you consider using this system regularly for balance checking? Why or why not?" and "What features would encourage you to use this system more often?" Interviews lasted 3-5 minutes, were audio-recorded with permission, transcribed verbatim, and analyzed using Braun and Clarke's six-phase thematic analysis framework.
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 Jan 2026.
- 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 Brief-BESTest assessment, Digital balance assessment tool and Gamified Digital Balance Assessment (GDBA) in people with ELDERLY PEOPLE and Fall 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 4 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 Jan 2026. 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?
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?
Perceived physical exertion (time frame: Through intervention completion, an average of 10 mins). The study lists 3 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 22 Jan 2026.