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

NCT05730790 | Unknown

• 1 other identifier: 2020/00262
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Change in number of falls measured using a falls diary

  Baseline, 6 month

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

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

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

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

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

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

• Change in executive function measured using Chinese Frontal Assessment Battery

  Baseline, 6 month

Study Arms (3)

Cognitive-motor dual task training (DTT)

EXPERIMENTAL

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)

Cognitive single task training (CSTT)

ACTIVE COMPARATOR

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)

Motor single task training (MSTT)

ACTIVE COMPARATOR

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)

Interventions

Cognitive-motor dual task training (DTT) OTHER

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%.

Cognitive-motor dual task training (DTT)

Cognitive single task training (CSTT) OTHER

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%.

Cognitive single task training (CSTT)

Motor single task training (MSTT) OTHER

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.

Motor single task training (MSTT)

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead
• Nanyang Polytechnic: collaborator
• National Neuroscience Institute: collaborator

Study Sites (1)

Tan Tock Seng Hospital

Singapore, 308433, Singapore

RECRUITING

Related Publications (10)

• 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.

  PMID: 30450069 BACKGROUND

• 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.

  PMID: 20445152 BACKGROUND

• 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.

  PMID: 21940172 BACKGROUND

• 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.

  PMID: 26079569 BACKGROUND

• 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.

  PMID: 28505243 BACKGROUND

• Delbroek T, Vermeylen W, Spildooren J. The effect of cognitive-motor dual task training with the biorescue force platform on cognition, balance and dual task performance in institutionalized older adults: a randomized controlled trial. J Phys Ther Sci. 2017 Jul;29(7):1137-1143. doi: 10.1589/jpts.29.1137. Epub 2017 Jul 15.

  PMID: 28744033 BACKGROUND

• 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.

  PMID: 9109884 BACKGROUND

• Mirelman A, Rochester L, Reelick M, Nieuwhof F, Pelosin E, Abbruzzese G, Dockx K, Nieuwboer A, Hausdorff JM. V-TIME: a treadmill training program augmented by virtual reality to decrease fall risk in older adults: study design of a randomized controlled trial. BMC Neurol. 2013 Feb 6;13:15. doi: 10.1186/1471-2377-13-15.

  PMID: 23388087 BACKGROUND

• Verghese J, Wang C, Lipton RB, Holtzer R. Motoric cognitive risk syndrome and the risk of dementia. J Gerontol A Biol Sci Med Sci. 2013 Apr;68(4):412-8. doi: 10.1093/gerona/gls191. Epub 2012 Sep 17.

  PMID: 22987797 BACKGROUND

• Abdin E, Subramaniam M, Achilla E, Chong SA, Vaingankar JA, Picco L, Sambasivam R, Pang S, Chua BY, Ng LL, Chua HC, Heng D, Prince M, McCrone P. The Societal Cost of Dementia in Singapore: Results from the WiSE Study. J Alzheimers Dis. 2016;51(2):439-49. doi: 10.3233/JAD-150930.

  PMID: 26890766 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Kwee Yong Joyce Yap, M.B.B.S.

  Tan Tock Seng Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

63596328; joyce_ky_yap@ttsh.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Block randomization

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 16, 2023
• Study Start: March 31, 2021
• Primary Completion: March 31, 2023
• Study Completion: September 1, 2023
• Last Updated: February 16, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)