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

Sponsor
University of Southern Queensland (Other)
Overall Status
Completed
CT.gov ID
NCT05971420
Collaborator
The Hong Kong Polytechnic University (Other)
18
1
2
6.5
2.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: VR activity-based
  • Other: Exercise-based (Baduanjin)
N/A

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

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Health Services Research
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
Actual Study Start Date :
Jul 1, 2021
Actual Primary Completion Date :
Dec 30, 2021
Actual Study Completion Date :
Jan 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: VR group

VR activity-based training

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.

Active Comparator: Exercise group

Exercise-based training (Baduanjin)

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Hong Kong Polytechnic University, St. James Settlement Hong Kong, Salvation Army Hong Kong Hong Kong China Hong Kong 0000

Sponsors and Collaborators

  • University of Southern Queensland
  • The Hong Kong Polytechnic University

Investigators

  • Principal Investigator: WING KEUNG IP, University of Southern Queensland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Southern Queensland
ClinicalTrials.gov Identifier:
NCT05971420
Other Study ID Numbers:
  • USQ AEC H21REA071
First Posted:
Aug 2, 2023
Last Update Posted:
Aug 2, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Southern Queensland
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 2, 2023