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Mild Cognitive ImpairmentNCT05730790

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

A study testing Cognitive-motor dual task training (DTT), Cognitive single task training (CSTT) and Motor single task training (MSTT) in people with Mild Cognitive Impairment, run by Tan Tock Seng Hospital at 1 site in Singapore.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 60 to 80 years
Conditions the study is for
Mild Cognitive Impairment
What is being tested?
Cognitive-motor dual task training (DTT), Cognitive single task training (CSTT) and Motor single task training (MSTT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteSingapore
Study dates
31 Mar 2021to 1 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

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

63596328

joyce_ky_yap@ttsh.com.sg

Singapore1 site, 1 recruiting
  • Tan Tock Seng Hospital

    Singapore, 308433

    Recruiting

Other trials in Singapore

About this study

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.

Read the 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.

Being tested
Cognitive-motor dual task training (DTT), Cognitive single task training (CSTT), Motor single task training (MSTT)
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 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%.

  • 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.

Study groups in NCT05730790
Study groupRoleWhat they receive
Cognitive-motor dual task training (DTT)ExperimentalParticipants 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.
Receives: Other: Cognitive-motor dual task training (DTT)
Cognitive single task training (CSTT)Active comparatorParticipants 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
Receives: Other: Cognitive single task training (CSTT)
Motor single task training (MSTT)Active comparatorParticipants 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
Receives: Other: Motor single task training (MSTT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. 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)

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

Secondary outcomes (7)
  1. Change in number of falls measured using a falls diary

    Number of falls in the past 12 months

    Measured: Baseline, 6 month

  2. 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.

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

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

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

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

  4. 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.

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

  5. 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.

    Measured: Baseline, 6 month

  6. 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.

    Measured: Baseline, 6 month

  7. 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

    Measured: Baseline, 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2023
  2. Study start31 Mar 2021
  3. Primary completion31 Mar 2023 (estimated)
  4. Study completion1 Sep 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Block randomization
Masking
None (open label)
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05730790
Sponsor's protocol ID
2020/00262
Status last verified
Feb 2023
First submitted
2 Feb 2023
Last updated
16 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30450069
  • 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.

    PubMed 20445152
  • 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.

    PubMed 21940172
  • 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.

    PubMed 26079569
  • 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.

    PubMed 28505243
  • 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.

    PubMed 28744033
  • 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.

    PubMed 9109884
  • 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.

    PubMed 23388087
  • 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.

    PubMed 22987797
  • 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.

    PubMed 26890766

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive-motor dual task training (DTT), Cognitive single task training (CSTT) and Motor single task training (MSTT) in people with Mild Cognitive Impairment, run by Tan Tock Seng Hospital at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Kwee Yong Joyce Yap, M.B.B.S. (63596328, joyce_ky_yap@ttsh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in dual-task gait cost measured using Optogait (time frame: Baseline, post-intervention after session 14 (week 7), 6 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05730790, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.

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