NCT05779189

Brief Summary

The purpose of this study is to explore the effectiveness between game-based virtual reality intervention and conventional health education in improving older adults' balance knowledge, and let them know how to prevent falling. The intervention group will receive virtual reality games in person and read the health education flier, while the control group was assigned to read the health education flier and follow suit the video of balance exercise.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

September 15, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 22, 2023

Completed
Last Updated

March 22, 2023

Status Verified

May 1, 2022

Enrollment Period

4 months

First QC Date

March 3, 2023

Last Update Submit

March 19, 2023

Conditions

Balance

Outcome Measures

Primary Outcomes (5)

  • Senior Fitness Test

    Participants were assigned to do 2 tasks of the test. One is time up and go, and the other one is eyes-open single-leg stance test. We recorded the time (in seconds) they took.

    Right after the intervention

  • Falls Efficacy Scale International

    Participants were assessed by the questionnaire, and we recorded the points of the participants. The higher the point is, the more concerned they are about the falls.

    Right after the intervention

  • Balance or sensory-Integration test

    The balance of postural-stability test and the modified clinical test of sensory integration and balance (m-CTSIB) were performed using the Biodex Stability System (BSS; Biodex Medical Systems, Shirley, New York, USA).

    Right after the intervention

  • Balance of postural-stability test

    The balance of postural stability was tested according to 3 stability indices (overall stability; anterior-to-posterior stability; and medial-to-lateral stability).

    Right after the intervention

  • Modified Clinical Test for Sensory Integration of Balance (m-CTSIB)

    The m-CTSIB, which includes 4 sway indices, was conducted 4 sensory conditions: (1) eyes open whilst standing on a firm surface (EOFIS); (2) eyes closed whilst standing on a firm surface (ECFIS): (3) eves open whilst standing on an unstable (foam) surface (EOFOS); and (4) eyes closed whilst standing on an unstable (foam) surface (ECFOS).

    Right after the intervention

Study Arms (2)

Intervention

EXPERIMENTAL

Participants will receive conventional health education and game-based virtual reality (game) in person.

Behavioral: Game-based virtual reality (Game)

Control

ACTIVE COMPARATOR

Participants will receive conventional health education and 4 video of balance exercise.

Behavioral: Conventional health education

Interventions

Game-based virtual reality (Game)BEHAVIORAL

Besides reading the health education flier, they also need to trained with the game-based virtual reality in Biodex Medical Systems, which is a machine, includes 4 games: Catch Game, boating, Ball Maze, and Word Search. And all of the games are balance control games. The games were implemented in person for 30 minutes one time, total is 16 times (once to twice day a week).

Intervention
Conventional health educationBEHAVIORAL

The health education flier was made refer to medical institutions, e.g., hospitals or clinics, the video of balance exercise was collected from the internet. Participants were assigned to read the health education flier, and follow suit the video of balance exercise at home of their free will.

Control

Eligibility Criteria

Age65 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Elderly people over the age of 65-99.

You may not qualify if:

  • cognitive impairment
  • neurological diseases
  • severe osteoporosis
  • lower limb joint surgery
  • discomfort symptoms during exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University

Taipei County, Taiwan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2023

First Posted

March 22, 2023

Study Start

September 15, 2022

Primary Completion

January 15, 2023

Study Completion

March 3, 2023

Last Updated

March 22, 2023

Record last verified: 2022-05

Locations

TW(1)