NCT07088848

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 28, 2025

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2025

Completed
Last Updated

July 28, 2025

Status Verified

July 1, 2025

Enrollment Period

4 months

First QC Date

July 19, 2025

Last Update Submit

July 19, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Balance Performance:

    Balance ability was assessed using the digitalized Brief-BESTest

    Through intervention completion, an average of 10 mins

Secondary Outcomes (1)

  • Fatigue level

    Through intervention completion, an average of 10 mins

Study Arms (2)

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.

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.

Device: Digitalized Brief-BESTest design

Interventions

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

Control group

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

Experimental group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hongqiao Community

Shanghai, Shanghai Municipality, 200240, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

July 19, 2025

First Posted

July 28, 2025

Study Start

April 20, 2025

Primary Completion

August 10, 2025

Study Completion

December 20, 2025

Last Updated

July 28, 2025

Record last verified: 2025-07

Locations