Effects of Game-based Virtual Reality Intervention on Senior Fitness, Fall Prevention and Balance Function Among Older Adults

March 19, 2023 updated by: Taipei Medical University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Falls can lead to disability, sickbed and even death of the elderly, and it ranks second among the top ten which causes death in Taiwan. In the past, when multifaceted exercise interventions were conducted for the elderly, most of them focused on group strength training and aerobic exercise, but lacked individualized balance training, resulting in a low degree of cooperation.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei county, Taiwan
        • Taipei Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 99 years (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Elderly people over the age of 65-99.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Participants will receive conventional health education and game-based virtual reality (game) in person.
Behavioral: Game-based virtual reality (Game)
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).
Active Comparator: Control
Participants will receive conventional health education and 4 video of balance exercise.
Behavioral: Conventional health education
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Senior Fitness Test
Time Frame: Right after the intervention
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
Time Frame: Right after the intervention
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
Time Frame: Right after the intervention
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
Time Frame: Right after the intervention
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)
Time Frame: Right after the intervention
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2022

Primary Completion (Actual)

January 15, 2023

Study Completion (Actual)

March 3, 2023

Study Registration Dates

First Submitted

March 3, 2023

First Submitted That Met QC Criteria

March 19, 2023

First Posted (Actual)

March 22, 2023

Study Record Updates

Last Update Posted (Actual)

March 22, 2023

Last Update Submitted That Met QC Criteria

March 19, 2023

Last Verified

May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • N202204048

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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