- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06539065
The Effects of VR Interactive Games on Balance and Quality of Life Enhancement for Elderly in the Community
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.
Study Overview
Detailed Description
Both groups will undergo three sessions per week, one hour per session, for a total of 12 weeks and 36 sessions of intervention. Before and after competing all sessions, the effectiveness of this intervention will be assessed.
Some physical assessments will be done by all participants such as 2-minute step, right chair sit and reach, left chair sit and reach to compare if any difference between two groups. and participants will do a questionaire to evaluate the psychological and environmental quality of life.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Taipei, Taiwan
- Taipei Medical University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 65 or above
- Capable of communicating in Mandarin or Taiwanese, and willing to participate in interviews or complete questionnaires
- Free of mobility impairments
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: VR group
The experimental group received a twelve-week intervention of 36 sessions using VR interactive games in their exercise prescription
|
The experimental group received a twelve-week intervention of 36 sessions using VR interactive games in their exercise prescription,
|
|
No Intervention: Non-VR group
control group followed the original instructor-led exercise intervention as the course content.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Balance ability
Time Frame: Physical assessment done 2 weeks before and 2 weeks after 12 weeks courses
|
The scores of five physical assessments
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Physical assessment done 2 weeks before and 2 weeks after 12 weeks courses
|
|
Life quality
Time Frame: Questionnaire done 2 weeks before and 2 weeks after 12 weeks courses
|
The score of questionnaire done by all participants
|
Questionnaire done 2 weeks before and 2 weeks after 12 weeks courses
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Chueh-Ho Lin, PhD, Taipei Medical University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- N202210004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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