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临床试验/NCT06958653
NCT06958653进行中(未招募)不适用

Gamified Digital Balance Assessment for Older Adults in Community Settings: Development, Validation, and User Experience Evaluation in a Mixed Methods Study

Shanghai Jiao Tong University School of Medicine2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年4月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
30
试验地点
2
主要终点
Balance ability

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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

研究组 & 干预措施

Control group

Active Comparator

Participants in the control group used Brief-BESTest to assess their balance ability

干预措施: Brief-BESTest assessment (Device)

Experimental group

Experimental

Participants in the experimental group uses the Gamified Digital Balance Assessment to assess their balance ability

干预措施: Digital balance assessment tool (Device)

结局指标

主要结局

Balance ability

时间窗: Through intervention completion, an average of 10 mins

The participants' balance ability was assessed using a combination of digital and traditional Brief-BESTest. The Brief-BESTest is a scientifically validated method for balance assessment that includes eight tests, consisting of six subsections aimed at evaluating balance posture control. For traditional Brief-BESTest, each item is scored on a scale from 0 to 3, with a maximum total score of 24 through healthcare professionals. For digital balance assessment tool (digital Brief-BESTest), the score is calculated based on the precision of movement detect through the camera and calculated through the algorithm.

次要结局

  • Exercise confidence(Through intervention completion, an average of 10 mins)
  • Fatigue level(Through intervention completion, an average of 10 mins)
  • User experience(Through intervention completion, an average of 10 mins)

研究者

发起方
Shanghai Jiao Tong University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jianan Zhao

Principle investigator

Shanghai Jiao Tong University School of Medicine

研究点 (2)

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