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

Mild Cognitive Impairment Clinical Trial

— MCI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05971420
• Other study ID #: USQ AEC H21REA071
• Status: Completed
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: January 15, 2022

Study information

• Verified date: July 2023
• Source: University of Southern Queensland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 falls prevention among community-dwelling older adults with mild cognitive impairment.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 15, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Exercise Training
• Fall Prevention
• Mild Cognitive Impairment
• Virtual Reality

Intervention

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.
• Exercise-based (Baduanjin)
The exercise group used a traditional Chinese Qigong Baduanjin exercise incorporating with a fall prevention education strategy.

Locations

Country	Name	City	State
Hong Kong	The Hong Kong Polytechnic University, St. James Settlement Hong Kong, Salvation Army Hong Kong	Hong Kong	China

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern Queensland	The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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