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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05779189
Other study ID # N202204048
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 15, 2022
Est. completion date March 3, 2023

Study information

Verified date May 2022
Source Taipei Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date March 3, 2023
Est. primary completion date January 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 99 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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).
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.

Locations

Country Name City State
Taiwan Taipei Medical University Taipei county

Sponsors (1)

Lead Sponsor Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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