Virtual Reality Activity-based Training for Preventing Falls for Older Adults With Mild Cognitive Impairment (MCI)

Virtual Reality Activity-based Training for Preventing Falls Among Community-dwelling Older Adults With Mild Cognitive Impairment: A Pilot Randomized Control Trial Study

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.

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment; Exercise Training; Virtual Reality; Fall Prevention
• Intervention / Treatment: Other: VR activity-based; Other: Exercise-based (Baduanjin)

Detailed Description

A pilot randomized control trial study was applied to compare the effects on falls prevention between participants who experienced a full-immersive VR training and group-based exercise (Baduanjin) training. Eighteen participants were recruited from ausing convenience sampling and were randomly assigned into the VR group and the exercise group (non-VR). The participants in both wo groups' participants attended 16 falls prevention training sessions over eight weeks. Eligible participants identified with a higher risk of mild cognitive impairment and early dementia undertook three measurements, pretest (T1), post-test (T2) and follow up (T3). The primary outcomes assessed included changes in physical risks factor of falls, and the secondary outcomes assessed included changes in cognition and fall efficacy.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • China
    • Hong Kong, China, Hong Kong, 0000
      • The Hong Kong Polytechnic University, St. James Settlement Hong Kong, Salvation Army Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. aged 65 years to 85 years inclusive;
2. had a history of a fall within the past 2 years;
3. community-dwelling older adults;
4. 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);
5. walk independently e.g. able to access publicly - VR research center centre or local community aged care facilities.

Exclusion Criteria:

if they had a medical diagnosis of unstable health conditions

1. dizziness;
2. Meniere's disease;
3. Epilepsy;
4. Parkinson's disease;
5. Severe hearing impairment and visual impairments;
6. Mental illness.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VR group; VR activity-based training	Other: VR activity-based; 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.
Active Comparator: Exercise group; Exercise-based training (Baduanjin)	Other: Exercise-based (Baduanjin); The exercise group used a traditional Chinese Qigong Baduanjin exercise incorporating with a fall prevention education strategy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive status assessed by Montreal Cognitive Assessment Scale- change is being assessed	To assess the cognitive level. Total score 30 ( score if less than 22 indicated higher risk of midl cognitive impairment	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	To assess the level of executive functions. It indicated the time of completion (second)	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	To assess the level of fear concern. Totoal score is 64 (score lower than 27 indicated less fear concern	At prettest, postest (up to 8 weeks) and post 3 months follow up

Collaborators and Investigators

• Sponsor: University of Southern Queensland
• Collaborators: The Hong Kong Polytechnic University
• Investigators: Principal Investigator: WING KEUNG IP, University of Southern Queensland

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): December 30, 2021
• Study Completion (Actual): January 15, 2022

Study Registration Dates

• First Submitted: July 8, 2023
• First Submitted That Met QC Criteria: July 24, 2023
• First Posted (Actual): August 2, 2023

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: July 24, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Ageing; MCI; VR; Fall risk
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: USQ AEC H21REA071

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No permission from participants

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No