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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Other: Cognitive-motor dual task training (DTT)
* Other: Cognitive single task training (CSTT)
* Other: Motor single task training (MSTT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Block randomization
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive-motor dual task training (DTT)<br>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)<br>* 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%.<br>|
| Active Comparator: Cognitive single task training (CSTT)<br>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)<br>* 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%.<br>|
| Active Comparator: Motor single task training (MSTT)<br>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)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in dual-task gait cost measured using Optogait | 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 | 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 | Number of falls in the past 12 months | Baseline, 6 month | 
| Change in balance parameters and falls risk measured using Berg Balance Scale (BBS) | 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) | 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) | 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 | 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) | 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 | 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 |