Immersive Virtual Reality for Dual-task Training in Older Adults With Mild Cognitive Impairment: A Randomized Controlled Trial

February 15, 2023 updated by: Tan Tock Seng Hospital
Mild cognitive impairment (MCI) is a pre-dementia state marked by a higher risk of conversion to dementia. Presently, strategies to delay the progression of MCI to dementia, such as routine exercise and cognitive activities, are limited and only moderately efficacious. Cognitive-motor dual task training, enhanced in a virtual reality environment, is a novel intervention for individuals with MCI.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A randomized controlled trial will be conducted. 54 patients with MCI will be recruited from an outpatient clinic. The participants will be randomly allocated to one of the three study arms. All three groups will participate in 2 training sessions per week for 7 weeks. Each session lasts 32 to 40 minutes.

Study Type

Interventional

Enrollment (Anticipated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Singapore
      • Singapore, Singapore, 308433
        • Recruiting
        • Tan Tock Seng Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 60 - 80 years of age
  • Diagnosis of mild cognitive impairment (MCI)
  • Able to walk independently without assistance, whether from a person or a walking aid

Exclusion Criteria:

  • Diagnosed dementia (at the point of recruitment)
  • Presence of end stage lung, cardiac, liver and/or renal disease
  • Unstable acute medical conditions that prevent one from exercising on a treadmill
  • Presence of active arthritis, with symptoms affecting function
  • Cerebrovascular and/or cardiac events in the last 6 months
  • Parkinson's disease
  • History of hip fracture within the last 6 months
  • History of epilepsy with seizures in the last 2 years
  • Poor vision, not correctable by glasses
  • Hearing difficulty (if unable to hear well at normal conversational volume)
  • Acute backache with pain affecting ambulation
  • Acute lower limb pain with pain affecting ambulation
  • Cervical spondylosis with myelopathy or cervical spine issues
  • Chronic vertigo
  • Vestibular problems, causing issues with balance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive-motor dual task training (DTT)
Participants attended 14 sessions (40 minutes each) of dual task cognitive-motor training, 2 times per week for 7 weeks. Each cognitive-motor training session comprised of performing a dual task activity - gameplay using a virtual reality (VR) system while walking on a treadmill, of progressive difficulty pitched to the participant's performance.
Other: Cognitive-motor dual task training (DTT)

For session 1 to 3, the training comprises of 4 cycles of the following: 2 min dual tasking, 2 min rest, 2 min dual tasking, 2 min rest. For session 4 to 6, the training comprises of 4 cycles of the following: 2.5 min dual tasking, 1.5 min rest, 2.5 min dual tasking, 1.5 min rest. For session 7 to 14, the training comprises of 4 cycles of the following: 3 min dual tasking, 1 min rest, 3 min dual tasking, 1 min rest. The treadmill speed is maintained at 40%, 50% and 60% of participant's original gait speed at session 1 to 3, 4 to 6, and 7 to 14 respectively.

There are 10 levels in the VR game. Participant will start at level 1 of VR game at session 1 and can progress to the next level at the subsequent session if game percentage > 80%.
Active Comparator: Cognitive single task training (CSTT)
Participants attended 14 sessions (32 minutes each) of single task cognitive training, 2 times per week for 7 weeks. Each cognitive training session comprised of game play using a virtual reality (VR) system, of progressive difficulty pitched to the participant's performance
Other: Cognitive single task training (CSTT)

For session 1 to 3, the training comprises of 4 cycles of the following: 2 min VR gaming, 2 min rest, 2 min VR gaming and 2 min rest. For session 4 to 6, the training comprises of 4 cycles of the following: 2.5 min VR gaming, 1.5 min rest, 2.5 min VR gaming and 1.5 min rest. For session 7 to 14, the training comprises of 4 cycles of the following: 3 min VR gaming, 1 min rest, 3 min VR gaming and 1 min rest.

There are 10 levels in the VR game. Participant will start at level 1 of VR game at session 1 and can progress to the next level at the subsequent session if game percentage > 80%.
Active Comparator: Motor single task training (MSTT)
Participants attended 14 sessions (40 minutes each) of single task motor training over a period of 7 weeks. Each motor training session comprised of walking on a treadmill, of progressive difficulty pitched to the participant's performance
Other: Motor single task training (MSTT)
For session 1 to 3, the training comprises of 4 cycles of the following: 8 min treadmill walking at 40% of participant's original gait speed followed by 2 min rest. For session 4 to 6, the training comprises of 4 cycles of the following: 8 min treadmill walking at 50% of participant's original gait speed followed by 2 min rest. For session 7 to 14, the training comprises of 4 cycles of the following: 8 min treadmill walking at 60% of the participant's original gait speed followed by 2 min rest.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in dual-task gait cost measured using Optogait
Time Frame: Baseline, post-intervention after session 14 (week 7), 6 month

Gait parameters collected include step length, single support time, double support time, step time, stride length, speed and cadence. Gait parameters are collected under both single and dual-task (serial seven subtraction and animal naming) conditions.

Dual-task cost calculated as 100*(single task parameter - dual-task parameter)/single task parameter
Baseline, post-intervention after session 14 (week 7), 6 month
Change in dual-task cognitive cost measured using corrected response rate of cognitive tasks
Time Frame: Baseline, post-intervention after session 14 (week 7), 6 month
Cognitive tasks include 30 seconds serial seven subtraction and animal naming, under both single and dual-task conditions (while walking)
Baseline, post-intervention after session 14 (week 7), 6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in number of falls measured using a falls diary
Time Frame: Baseline, 6 month
Number of falls in the past 12 months
Baseline, 6 month
Change in balance parameters and falls risk measured using Berg Balance Scale (BBS)
Time Frame: Baseline, post-intervention after session 14 (week 7), 6 month
BBS is a 14-item tool which objectively assesses static balance and falls risk.
Baseline, post-intervention after session 14 (week 7), 6 month
Change in falls risk measured using Timed Up and Go test (TUG)
Time Frame: Baseline, post-intervention after session 14 (week 7), 6 month
TUG is a evaluative tool which assesses functional mobility and falls risk
Baseline, post-intervention after session 14 (week 7), 6 month
Change in falls concerns scored using the Falls Efficacy Scale International (FES-I)
Time Frame: Baseline, post-intervention after session 14 (week 7), 6 month
FES-I is a 16-item questionnaire used to measure the level of concern about falling during social and physical activities.
Baseline, post-intervention after session 14 (week 7), 6 month
Change in executive function measured using Chinese Frontal Assessment Battery
Time Frame: Baseline, 6 month
CFAB is brief tool used to assess frontal dysfunction via a series of neuropsychological tasks. A higher score indicates better performance with a total maximum of 18.
Baseline, 6 month
Change in executive function scored using the Stroop color-word test - Victoria version (VST)
Time Frame: Baseline, 6 month
VST assess executive functioning using three conditions that consist in naming color of dots, of neutral words, and of color words printed in incongruent colors.
Baseline, 6 month
Change in sustained and divided attention assessed using Color Trails Test 1 and 2
Time Frame: Baseline, 6 month
Color Trails Test is the language free version of Trails Making Test, developed for cross-cultural assessment of sustained and divided attention in adults
Baseline, 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tan Tock Seng Hospital

Collaborators

National Neuroscience Institute
Nanyang Polytechnic

Investigators

  • Principal Investigator: Kwee Yong Joyce Yap, M.B.B.S., Tan Tock Seng Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2021

Primary Completion (Anticipated)

March 31, 2023

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

February 2, 2023

First Submitted That Met QC Criteria

February 15, 2023

First Posted (Estimate)

February 16, 2023

Study Record Updates

Last Update Posted (Estimate)

February 16, 2023

Last Update Submitted That Met QC Criteria

February 15, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020/00262

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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