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Completed

NCT Number: NCT05971420

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

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.

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Key information

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Hong Kong, China, 0000

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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.

Treatment and study plan

VR activity-based

Other

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.

Exercise-based (Baduanjin)

Other

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

Primary outcomes

  1. Berg balance test (BBS) - change is being assessed

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

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

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

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

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

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

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

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

Secondary outcomes

  1. Cognitive status assessed by Montreal Cognitive Assessment Scale- change is being assessed

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

    To assess the cognitive level. Total score 30 ( score if less than 22 indicated higher risk of midl cognitive impairment

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

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

    To assess the level of executive functions. It indicated the time of completion (second)

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

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

    To assess the level of fear concern. Totoal score is 64 (score lower than 27 indicated less fear concern

Sponsors and collaborators

Lead sponsor

University of Southern Queensland

Other

Collaborators

  • The Hong Kong Polytechnic University

Registry information

Official study title

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

Acronym: MCI

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Aug 2, 2023
Registry last updated
Aug 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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