NCT06539065

Brief Summary

The goal of this clinical trial is to learn about the effectiveness of the incorporating VR interactive games into exercise courses of the elderly in the community.The main questions It aims to answer are: can It improve their balance ability and the quality of life. Participants will receive a Twelve-week intervention of 36 sessions using VR interactive games in their exercise prescription, While the control group will follow the original iInstructor-led exercise intervention as the course content.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 13, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2023

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2023

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

August 6, 2024

Completed
Last Updated

August 6, 2024

Status Verified

June 1, 2023

Enrollment Period

4 months

First QC Date

June 29, 2023

Last Update Submit

August 2, 2024

Conditions

Keywords

VRBalanceQuality of life

Outcome Measures

Primary Outcomes (2)

  • Balance ability

    The scores of five physical assessments

    Physical assessment done 2 weeks before and 2 weeks after 12 weeks courses

  • Life quality

    The score of questionnaire done by all participants

    Questionnaire done 2 weeks before and 2 weeks after 12 weeks courses

Study Arms (2)

VR group

EXPERIMENTAL

The experimental group received a twelve-week intervention of 36 sessions using VR interactive games in their exercise prescription

Device: VR interactive games

Non-VR group

NO INTERVENTION

control group followed the original instructor-led exercise intervention as the course content.

Interventions

The experimental group received a twelve-week intervention of 36 sessions using VR interactive games in their exercise prescription,

VR group

Eligibility Criteria

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

You may qualify if:

  • Aged 65 or above
  • Capable of communicating in Mandarin or Taiwanese, and willing to participate in interviews or complete questionnaires
  • Free of mobility impairments

You may not qualify if:

  • Stroke with sequelae of mobility impairments
  • Parkinson's disease
  • Motor neurone disease
  • Severe Cardio-vascular disease
  • Degenerative joint disease with flare-ups in past three months
  • With a lower limb joint surgery in past 3 months
  • Vertigo

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei medical University

Taipei, Taiwan

Location

Study Officials

  • Chueh-Ho Lin, PhD

    Taipei Medical University

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

June 29, 2023

First Posted

August 6, 2024

Study Start

February 13, 2023

Primary Completion

June 5, 2023

Study Completion

June 15, 2023

Last Updated

August 6, 2024

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share

the datasets generated in this study are available from the corresponding author upon reasonable request.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
the datasets generated in this study are available from the corresponding author upon reasonable request.
Access Criteria
no criteria

Locations