NCT05971420

Brief Summary

Using a Virtual Reality (VR) games-based application is as an innovative falls prevention technology in an aged care service. The VR intervention has promising effects on improving the physical and balance performances in the older adults.The study explored and evaluated the effects of VR activity-based training on falls prevention among community-dwelling older adults with mild cognitive impairment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

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

July 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2022

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 8, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

August 2, 2023

Completed
Last Updated

August 2, 2023

Status Verified

July 1, 2023

Enrollment Period

6 months

First QC Date

July 8, 2023

Last Update Submit

July 24, 2023

Conditions

Keywords

Fall riskVRMCIAgeing

Outcome Measures

Primary Outcomes (3)

  • Berg balance test (BBS) - change is being assessed

    To test the balance performance and assess the fall risk. Total score is 56 ( score below 51 indicated predictive of fall risk)

    At prettest, postest (up to 8 weeks) and post 3 months follow up

  • Time up and go test (TUG) - change is being assessed

    To assess functional mobility and assess the fall risk. Score over 12 seconds indicates higher risk of fall for the older adults

    At prettest, postest (up to 8 weeks) and post 3 months follow up

  • Six minutes walk test (6MWT) - change is being assessed

    To assess the walking speed and performance. Walking distance within 6 minutes measured the length (m/metre)

    At prettest, postest (up to 8 weeks) and post 3 months follow up

Secondary Outcomes (3)

  • Cognitive status assessed by Montreal Cognitive Assessment Scale- change is being assessed

    At prettest, postest (up to 8 weeks) and post 3 months follow up

  • Executive functioning tests by Trail making test A and test B *TMTA/B) - change is being assessed

    At prettest, postest (up to 8 weeks) and post 3 months follow up

  • Fall efficacy by fall efficacy international scale (FESI) - change is being assessed

    At prettest, postest (up to 8 weeks) and post 3 months follow up

Study Arms (2)

VR group

EXPERIMENTAL

VR activity-based training

Other: VR activity-based

Exercise group

ACTIVE COMPARATOR

Exercise-based training (Baduanjin)

Other: Exercise-based (Baduanjin)

Interventions

VR games activities were chosen for simulated cognitive-motor training in the VR group. The VR training modules for this study included fire drill, walking exercise, balancing game activities and community shopping practices. These training modules involved dual task components; the participant was expected to train up his/her physical and cognitive motor performances in an 8-week VR activity-based program. VR group participants received 2-sessions per week, 16 training sessions in total.

VR group

The exercise group used a traditional Chinese Qigong Baduanjin exercise incorporating with a fall prevention education strategy.

Exercise group

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • aged 65 years to 85 years inclusive;
  • had a history of a fall within the past 2 years;
  • community-dwelling older adults;
  • at a higher risk of mild cognitive impairment and dementia, assessed by a validated screening tool of Hong Kong Montreal Cognitive assessment test (HK-MoCA score=21/22);
  • walk independently e.g. able to access publicly - VR research center centre or local community aged care facilities.

You may not qualify if:

  • if they had a medical diagnosis of unstable health conditions
  • dizziness;
  • Meniere's disease;
  • Epilepsy;
  • Parkinson's disease;
  • Severe hearing impairment and visual impairments;
  • Mental illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University, St. James Settlement Hong Kong, Salvation Army Hong Kong

Hong Kong, China, 0000, Hong Kong

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • WING KEUNG IP

    University of Southern Queensland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2023

First Posted

August 2, 2023

Study Start

July 1, 2021

Primary Completion

December 30, 2021

Study Completion

January 15, 2022

Last Updated

August 2, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

No permission from participants

Locations