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

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05730790
• Other study ID #: 2020/00262
• Status: Recruiting
• Phase: N/A
• Start date: March 31, 2021
• Est. completion date: September 1, 2023

Study information

• Verified date: February 2023
• Source: Tan Tock Seng Hospital
• Contact: Kwee Yong Joyce Yap, M.B.B.S.
• Phone: 63596328
• Email: joyce_ky_yap[@]ttsh.com.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: September 1, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

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%.
• 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%.
• 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.

Locations

Country	Name	City	State
Singapore	Tan Tock Seng Hospital	Singapore

Sponsors (3)

Lead Sponsor	Collaborator
Tan Tock Seng Hospital	Nanyang Polytechnic, National Neuroscience Institute

Country where clinical trial is conducted

Singapore, 

References & Publications (10)

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. — View 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. — View Citation

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. — View 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. — View Citation

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. — View 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. — View 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. — View 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. — View 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in number of falls measured using a falls diary	Number of falls in the past 12 months	Baseline, 6 month
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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