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

Primary Purpose

Mild Cognitive Impairment, Fall Prevention, Virtual Reality

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
VR activity-based
Exercise-based (Baduanjin)
Sponsored by
University of Southern Queensland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Mild Cognitive Impairment focused on measuring Fall risk, VR, MCI, Ageing

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

VR group

Exercise group

Arm Description

VR activity-based training

Exercise-based training (Baduanjin)

Outcomes

Primary Outcome Measures

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)
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
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)

Secondary Outcome Measures

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
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)
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

Full Information

First Posted
July 8, 2023
Last Updated
July 24, 2023
Sponsor
University of Southern Queensland
Collaborators
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT05971420
Brief Title
Virtual Reality Activity-based Training for Preventing Falls for Older Adults With Mild Cognitive Impairment
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
January 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern Queensland
Collaborators
The Hong Kong Polytechnic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Fall Prevention, Virtual Reality, Exercise Training
Keywords
Fall risk, VR, MCI, Ageing

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VR group
Arm Type
Experimental
Arm Description
VR activity-based training
Arm Title
Exercise group
Arm Type
Active Comparator
Arm Description
Exercise-based training (Baduanjin)
Intervention Type
Other
Intervention Name(s)
VR activity-based
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise-based (Baduanjin)
Intervention Description
The exercise group used a traditional Chinese Qigong Baduanjin exercise incorporating with a fall prevention education strategy.
Primary Outcome Measure Information:
Title
Berg balance test (BBS) - change is being assessed
Description
To test the balance performance and assess the fall risk. Total score is 56 ( score below 51 indicated predictive of fall risk)
Time Frame
At prettest, postest (up to 8 weeks) and post 3 months follow up
Title
Time up and go test (TUG) - change is being assessed
Description
To assess functional mobility and assess the fall risk. Score over 12 seconds indicates higher risk of fall for the older adults
Time Frame
At prettest, postest (up to 8 weeks) and post 3 months follow up
Title
Six minutes walk test (6MWT) - change is being assessed
Description
To assess the walking speed and performance. Walking distance within 6 minutes measured the length (m/metre)
Time Frame
At prettest, postest (up to 8 weeks) and post 3 months follow up
Secondary Outcome Measure Information:
Title
Cognitive status assessed by Montreal Cognitive Assessment Scale- change is being assessed
Description
To assess the cognitive level. Total score 30 ( score if less than 22 indicated higher risk of midl cognitive impairment
Time Frame
At prettest, postest (up to 8 weeks) and post 3 months follow up
Title
Executive functioning tests by Trail making test A and test B *TMTA/B) - change is being assessed
Description
To assess the level of executive functions. It indicated the time of completion (second)
Time Frame
At prettest, postest (up to 8 weeks) and post 3 months follow up
Title
Fall efficacy by fall efficacy international scale (FESI) - change is being assessed
Description
To assess the level of fear concern. Totoal score is 64 (score lower than 27 indicated less fear concern
Time Frame
At prettest, postest (up to 8 weeks) and post 3 months follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
WING KEUNG IP
Organizational Affiliation
University of Southern Queensland
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hong Kong Polytechnic University, St. James Settlement Hong Kong, Salvation Army Hong Kong
City
Hong Kong
State/Province
China
ZIP/Postal Code
0000
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No permission from participants

Learn more about this trial

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

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