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

NCT ID: NCT05730790

Last Updated: 2023-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-31

Study Completion Date

2023-09-01

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.

Conditions

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Mild Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Block randomization
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Cognitive-motor dual task training (DTT)

Intervention Type 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 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

Group Type ACTIVE_COMPARATOR

Cognitive single task training (CSTT)

Intervention Type 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%.

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

Group Type ACTIVE_COMPARATOR

Motor single task training (MSTT)

Intervention Type 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.

Interventions

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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%.

Intervention Type 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%.

Intervention Type 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.

Intervention Type OTHER

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
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanyang Polytechnic

OTHER

Sponsor Role collaborator

National Neuroscience Institute

OTHER

Sponsor Role collaborator

Tan Tock Seng Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Tan Tock Seng Hospital

Locations

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Tan Tock Seng Hospital

Singapore, , Singapore

Site Status RECRUITING

Countries

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Singapore

Central Contacts

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

Role: CONTACT

References

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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.

Reference Type BACKGROUND
PMID: 30450069 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20445152 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21940172 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26079569 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28505243 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28744033 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9109884 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23388087 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22987797 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26890766 (View on PubMed)

Other Identifiers

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2020/00262

Identifier Type: -

Identifier Source: org_study_id

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