Mild Cognitive ImpairmentMCINCT05971420
Virtual Reality Activity-based Training for Preventing Falls for Older Adults With Mild Cognitive Impairment
A study testing VR activity-based and Exercise-based (Baduanjin) in people with Mild Cognitive Impairment and Fall Prevention, run by University of Southern Queensland at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment, Fall Prevention, Virtual Reality
- What is being tested?
- VR activity-based and Exercise-based (Baduanjin)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jul 2021to 15 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
The Hong Kong Polytechnic University, St. James Settlement Hong Kong, Salvation Army Hong Kong
Hong Kong, China, 0000
About this study
Official title: 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.
Read the 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.
- Being tested
- VR activity-based, Exercise-based (Baduanjin)
- Keywords
- Fall risk, VR, MCI, Ageing
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR activity-basedOther
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.
| Study group | Role | What they receive |
|---|---|---|
| VR group | Experimental | VR activity-based training Receives: Other: VR activity-based |
| Exercise group | Active comparator | Exercise-based training (Baduanjin) Receives: Other: Exercise-based (Baduanjin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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)
Measured: 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
To assess the cognitive level. Total score 30 ( score if less than 22 indicated higher risk of midl cognitive impairment
Measured: 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)
Measured: 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
Measured: At prettest, postest (up to 8 weeks) and post 3 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start1 Jul 2021
- Primary completion30 Dec 2021
- Study completion15 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Queensland
- Sponsor type
- University, hospital or other
- Collaborators
- The Hong Kong Polytechnic University
- Responsible party
- Sponsor
- Investigators
- WING KEUNG IP, Principal investigator, University of Southern Queensland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05971420
- Sponsor's protocol ID
- USQ AEC H21REA071
- Acronym
- MCI
- Status last verified
- Jul 2023
- First submitted
- 8 Jul 2023
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No permission from participants
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Activity-based Training for Preventing Falls Among Community-dwelling Older Adults With Mild Cognitive Impairment: A Pilot Randomized Control Trial Study
- ClinicalTrials.gov ID
- NCT05971420
- Acronym / sponsor ID
- MCI / USQ AEC H21REA071
- Keywords
- Fall risk, VR, MCI, Ageing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Southern QueenslandUniversity, hospital or other
- Collaborators
- The Hong Kong Polytechnic University
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 15 Jan 2022 (actual)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR group | Experimental | Other: VR activity-basedVR activity-based training |
| Exercise group | Active comparator | Other: Exercise-based (Baduanjin)Exercise-based training (Baduanjin) |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- if they had a medical diagnosis of unstable health conditions
- dizziness;
- Meniere's disease;
- Epilepsy;
- Parkinson's disease;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR activity-basedVR 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. | Other | VR group |
| Exercise-based (Baduanjin)The exercise group used a traditional Chinese Qigong Baduanjin exercise incorporating with a fall prevention education strategy. | Other | Exercise group |
Primary outcome
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)
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
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)
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Individual participant dataSharing planned: No. No permission from participants
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
WING KEUNG IP principal investigator
University of Southern Queensland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR activity-based and Exercise-based (Baduanjin) in people with Mild Cognitive Impairment and Fall Prevention, run by University of Southern Queensland at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg balance test (BBS) - change is being assessed (time frame: At prettest, postest (up to 8 weeks) and post 3 months follow up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2023.