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

Primary Purpose

Mild Cognitive Impairment

Status

Recruiting

Phase

Not Applicable

Locations

Singapore

Study Type

Interventional

Intervention

Cognitive-motor dual task training (DTT)

Cognitive single task training (CSTT)

Motor single task training (MSTT)

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Tan Tock Seng HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive-motor dual task training (DTT)

Cognitive single task training (CSTT)

Motor single task training (MSTT)

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

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

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)

Secondary Outcome Measures

Change in number of falls measured using a falls diary

Number of falls in the past 12 months

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.

Change in falls risk measured using Timed Up and Go test (TUG)

TUG is a evaluative tool which assesses functional mobility and falls risk

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.

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.

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.

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

Full Information

NCT ID

NCT05730790

First Posted

February 2, 2023

Last Updated

February 15, 2023

Sponsor

Tan Tock Seng Hospital

Collaborators

Nanyang Polytechnic, National Neuroscience Institute

1. Study Identification

Unique Protocol Identification Number

NCT05730790

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 31, 2021 (Actual)

Primary Completion Date

March 31, 2023 (Anticipated)

Study Completion Date

September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tan Tock Seng Hospital

Collaborators

Nanyang Polytechnic, National Neuroscience Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mild Cognitive Impairment

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Block randomization

Masking

None (Open Label)

Allocation

Randomized

Enrollment

54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cognitive-motor dual task training (DTT)

Arm Type

Experimental

Arm Description

Arm Title

Cognitive single task training (CSTT)

Arm Type

Active Comparator

Arm Description

Arm Title

Motor single task training (MSTT)

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

Cognitive-motor dual task training (DTT)

Intervention Description

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%.

Intervention Type

Other

Intervention Name(s)

Cognitive single task training (CSTT)

Intervention Description

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%.

Intervention Type

Other

Intervention Name(s)

Motor single task training (MSTT)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in dual-task gait cost measured using Optogait

Description

Time Frame

Baseline, post-intervention after session 14 (week 7), 6 month

Title

Change in dual-task cognitive cost measured using corrected response rate of cognitive tasks

Description

Cognitive tasks include 30 seconds serial seven subtraction and animal naming, under both single and dual-task conditions (while walking)

Time Frame

Baseline, post-intervention after session 14 (week 7), 6 month

Secondary Outcome Measure Information:

Title

Change in number of falls measured using a falls diary

Description

Number of falls in the past 12 months

Time Frame

Baseline, 6 month

Title

Change in balance parameters and falls risk measured using Berg Balance Scale (BBS)

Description

BBS is a 14-item tool which objectively assesses static balance and falls risk.

Time Frame

Baseline, post-intervention after session 14 (week 7), 6 month

Title

Change in falls risk measured using Timed Up and Go test (TUG)

Description

TUG is a evaluative tool which assesses functional mobility and falls risk

Time Frame

Baseline, post-intervention after session 14 (week 7), 6 month

Title

Change in falls concerns scored using the Falls Efficacy Scale International (FES-I)

Description

FES-I is a 16-item questionnaire used to measure the level of concern about falling during social and physical activities.

Time Frame

Baseline, post-intervention after session 14 (week 7), 6 month

Title

Change in executive function measured using Chinese Frontal Assessment Battery

Description

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.

Time Frame

Baseline, 6 month

Title

Change in executive function scored using the Stroop color-word test - Victoria version (VST)

Description

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.

Time Frame

Baseline, 6 month

Title

Change in sustained and divided attention assessed using Color Trails Test 1 and 2

Description

Color Trails Test is the language free version of Trails Making Test, developed for cross-cultural assessment of sustained and divided attention in adults

Time Frame

Baseline, 6 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kwee Yong Joyce Yap, M.B.B.S.

Phone

63596328

joyce_ky_yap@ttsh.com.sg

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kwee Yong Joyce Yap, M.B.B.S.

Organizational Affiliation

Tan Tock Seng Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tan Tock Seng Hospital

City

Singapore

ZIP/Postal Code

308433

Country

Singapore

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30450069

Citation

Perez-Marcos D, Bieler-Aeschlimann M, Serino A. Virtual Reality as a Vehicle to Empower Motor-Cognitive Neurorehabilitation. Front Psychol. 2018 Nov 2;9:2120. doi: 10.3389/fpsyg.2018.02120. eCollection 2018.

Results Reference

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PubMed Identifier

20445152

Citation

Schwenk M, Zieschang T, Oster P, Hauer K. Dual-task performances can be improved in patients with dementia: a randomized controlled trial. Neurology. 2010 Jun 15;74(24):1961-8. doi: 10.1212/WNL.0b013e3181e39696. Epub 2010 May 5.

Results Reference

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PubMed Identifier

21940172

Citation

Muir SW, Speechley M, Wells J, Borrie M, Gopaul K, Montero-Odasso M. Gait assessment in mild cognitive impairment and Alzheimer's disease: the effect of dual-task challenges across the cognitive spectrum. Gait Posture. 2012 Jan;35(1):96-100. doi: 10.1016/j.gaitpost.2011.08.014. Epub 2011 Sep 22.

Results Reference

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PubMed Identifier

26079569

Citation

Fritz NE, Cheek FM, Nichols-Larsen DS. Motor-Cognitive Dual-Task Training in Persons With Neurologic Disorders: A Systematic Review. J Neurol Phys Ther. 2015 Jul;39(3):142-53. doi: 10.1097/NPT.0000000000000090.

Results Reference

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PubMed Identifier

28505243

Citation

Montero-Odasso MM, Sarquis-Adamson Y, Speechley M, Borrie MJ, Hachinski VC, Wells J, Riccio PM, Schapira M, Sejdic E, Camicioli RM, Bartha R, McIlroy WE, Muir-Hunter S. Association of Dual-Task Gait With Incident Dementia in Mild Cognitive Impairment: Results From the Gait and Brain Study. JAMA Neurol. 2017 Jul 1;74(7):857-865. doi: 10.1001/jamaneurol.2017.0643. Erratum In: JAMA Neurol. 2017 Nov 1;74(11):1381.

Results Reference

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PubMed Identifier

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Citation

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Results Reference

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PubMed Identifier

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Citation

Camicioli R, Howieson D, Lehman S, Kaye J. Talking while walking: the effect of a dual task in aging and Alzheimer's disease. Neurology. 1997 Apr;48(4):955-8. doi: 10.1212/wnl.48.4.955.

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Citation

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Citation

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

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