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

Study Overview
=================
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.

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.

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

Conditions
-----------------
Mild Cognitive Impairment, Fall Prevention, Virtual Reality, Exercise Training

Intervention / Treatment
-----------------
* Other: VR activity-based
* Other: Exercise-based (Baduanjin)


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fall risk, VR, MCI, Ageing