Dual-taskCo-ACT&LEARNNCT04666181
Cortical Activation and Cognitive-Motor Learning
A study testing Dual-task training in people with Dual-task and Healthy Adults, run by East Carolina University at 1 site in United States.
Trial summary
The purpose of this research study is to assess the effects of dual-task training using a dynamic balance task and an auditory reaction time task on dual-task performance in healthy young adults and to assess the cortical activity within the prefrontal and sensorimotor cortices in response to dual-task training using… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Dual-task, Healthy Adults
- What is being tested?
- Dual-task training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2021to 30 Nov 2021
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy young adults
- Right-handed
Who cannot join
- Individuals with cognitive deficits or communication problems
- Individuals with impaired vision
- Individuals with balance disorders such as vestibular disorders, etc.
- Individuals with known cardiorespiratory dysfunctions
- Individuals with presence of lower extremity condition, injury, or surgery within last 3 months which could compromise training
- Individuals with history of concussion
Trial locations and contacts
1 site in 1 country.
United States1 site
East Carolina University
Greenville, North Carolina, 27834
About this study
Official title: Effects of Dual-Task Training on Cognitive and Motor Learning and Cortical Activation in Healthy Young Adults
The purpose of this research study is to assess the effects of dual-task training using a dynamic balance task and an auditory reaction time task on dual-task performance in healthy young adults and to assess the cortical activity within the prefrontal and sensorimotor cortices in response to dual-task training using functional near infrared spectroscopy (fNIRS).
Read the detailed description
The purpose of this study is to assess the influence of a dual-task (combined motor-cognitive task) on dual-task performance of a complex dynamic stability task in healthy young adults and to assess the effects of dual-task training on cognitive-motor learning and cortical activation in healthy young adults. A dual-task is defined as concurrent performance of two tasks, usually a cognitive and motor task, that can be performed independently and have distinct and separate goals. Individuals engage in dual tasks every day and must allocate attentional resources to each task. While recognition of susceptibility to performance decrements in dual-task settings may be difficult, increased dual-task complexity is associated with decreased performance in one or both tasks. The well documented effects of dual-task practice represent a promising approach to improve dual-task performance for clinical populations such as individuals with neurological conditions or older individuals, in which complex multitask situations can increase fall risk due to hindered balance and walking performance. Similarly, young adults have demonstrated performance decrements while executing a dual-task that involved a combined balance and cognitive task. Research of dual-task training in healthy young cohort has indicated significant improvements in both motor and cognitive task performance in dual-task situations, suggesting the efficiency of this intervention strategy. However, most of these studies have investigated effects of a simple postural task combined with cognitive task training on dual-task performance. Effects of dual-task training using a complex dynamic postural stability task on dual-task performance of such complex task is lacking. Moreover, existing studies demonstrate conflicting evidence of dual-task training effects among healthy young adults since improvements in the motor task only have been largely reported. It is crucial to understand dual-task training effects on performance of a complex cognitive-motor task since postural control involves complex integration of somatosensory, vestibular, and visual systems. Our experimental paradigm will challenge these systems; thus, findings of this study would inform our intervention strategies in a variety of populations ranging from athletes to individuals with neurological conditions.
Dynamic postural stability is an integral aspect of postural control and it involves complex interaction of prefrontal, somatosensory, vestibular, and visual systems. However, a motor task involving complex interaction of these systems combined with cognitive task challenges has not been investigated thoroughly. Moreover, neural activation within these cortical areas during dual-task performance and effects of dual-task training are largely unknown.
Since, coordinated control of the body requires integration of all these systems (i.e. prefrontal, somatosensory, vestibular, and visual), it is important to systemically study the interference of an additional attention-demanding task, such as an auditory stimulus reaction time task on interaction of these systems that may contribute to decreased postural stability. Moreover, it is important to investigate if training on such a complex dual-task can reduce motor-cognitive interference, improve postural stability, and optimize cortical activation in complex dual-task conditions.
- Conditions
- Dual-task, Healthy Adults
- Being tested
- Dual-task training
- Keywords
- Cognition, Motor, Dual-task, Prefrontal cortex, Sensorimotor cortex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-task trainingBehavioural
See descriptions under arm description. The dual-task training will occur across a total of 5 consecutive workday visits.
| Study group | Role | What they receive |
|---|---|---|
| Dual-task training | Experimental | Dual-task training will consist of balancing on the dynamic stability platform and responding to auditory stimuli. Participants will perform 18 trials total in 3 blocks of 6 trials. Each trial will be 30 seconds (s) in duration followed by 30 s of rest (i.e. quiet standing on the platform while holding onto the rails.) Between each training block, the participant will step off the platform and rest for 2 minutes. Dual-task training will occur on consecutive visits 2-6. Receives: Behavioral: Dual-task training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in auditory reaction time task performance
Average amount of time in seconds for a button press in response to an auditory tone
Measured: Baseline to 10 days, and upto 3 weeks. Shorter reaction time indicates better performance.
Change in balance task performance
The average amount of time in seconds that a participant maintains the stability platform within 3 degrees of horizontal position during 6 trials of 30 sec each. The total score will range between 0-30 s. Higher balance score indicates better balance performance.
Measured: Baseline to 10 days, and upto 3 weeks
Change in dual-task performance
Dual-task performance will assess performance on the combined auditory reaction time task and the balance task, i.e. performance under influence of dual-task situation.
Measured: Baseline to 10 days, and upto 3 weeks
Change in Cortical Activation
The amount of change in cortical activity (change in oxyhemoglobin concentration in umol) within the prefrontal and sensorimotor cortices in response to dual-task training.
Measured: Baseline to 10 days, and upto 3 weeks
Secondary outcomes (2)
Errors in auditory reaction time task performance
Error is a wrong button pressed in response to the auditory tone
Measured: Baseline to 10 days, and upto 3 weeks
Balance variability
The average amount of time in seconds on the left and right side of the dynamic stability platform outside of 3 degrees in the center during 6 trials of 30 seconds each. Smaller time on the right and left side indicates improvement in variability.
Measured: Baseline to 10 days, and upto 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start15 Jan 2021
- Primary completion30 Aug 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Dual-taskStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Swati Manoharrao Surkar, East Carolina University
- Investigators
- Swati M Surkar, PhD, Principal investigator, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04666181
- Sponsor's protocol ID
- 20-001938
- Acronym
- Co-ACT&LEARN
- Status last verified
- Jan 2022
- First submitted
- 23 Nov 2020
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will share after the completion of the study upon request to the PI.
Publications
Beauchet O, Dubost V, Herrmann FR, Kressig RW. Stride-to-stride variability while backward counting among healthy young adults. J Neuroeng Rehabil. 2005 Aug 11;2:26. doi: 10.1186/1743-0003-2-26.
PubMed 16095533Fraser SA, Li KZ, Berryman N, Desjardins-Crepeau L, Lussier M, Vadaga K, Lehr L, Minh Vu TT, Bosquet L, Bherer L. Does Combined Physical and Cognitive Training Improve Dual-Task Balance and Gait Outcomes in Sedentary Older Adults? Front Hum Neurosci. 2017 Jan 18;10:688. doi: 10.3389/fnhum.2016.00688. eCollection 2016.
PubMed 28149274Ghai S, Ghai I, Effenberg AO. Effects of dual tasks and dual-task training on postural stability: a systematic review and meta-analysis. Clin Interv Aging. 2017 Mar 23;12:557-577. doi: 10.2147/CIA.S125201. eCollection 2017.
PubMed 28356727Kiss R, Brueckner D, Muehlbauer T. Effects of Single Compared to Dual Task Practice on Learning a Dynamic Balance Task in Young Adults. Front Psychol. 2018 Mar 12;9:311. doi: 10.3389/fpsyg.2018.00311. eCollection 2018.
PubMed 29593614Pinti P, Tachtsidis I, Hamilton A, Hirsch J, Aichelburg C, Gilbert S, Burgess PW. The present and future use of functional near-infrared spectroscopy (fNIRS) for cognitive neuroscience. Ann N Y Acad Sci. 2020 Mar;1464(1):5-29. doi: 10.1111/nyas.13948. Epub 2018 Aug 7.
PubMed 30085354Techayusukcharoen R, Iida S, Aoki C. Observing brain function via functional near-infrared spectroscopy during cognitive program training (dual task) in young people. J Phys Ther Sci. 2019 Jul;31(7):550-555. doi: 10.1589/jpts.31.550. Epub 2019 Jul 9.
PubMed 31417220
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dual-Task Training on Cognitive and Motor Learning and Cortical Activation in Healthy Young Adults
- ClinicalTrials.gov ID
- NCT04666181
- Acronym / sponsor ID
- Co-ACT&LEARN / 20-001938
- Conditions
- Dual-task, Healthy Adults
- Keywords
- Cognition, Motor, Dual-task, Prefrontal cortex, Sensorimotor cortex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 14 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to assess the effects of dual-task training using a dynamic balance task and an auditory reaction time task on dual-task performance in healthy young adults and to assess the cortical activity within the prefrontal and sensorimotor cortices in response to dual-task training using functional near infrared spectroscopy (fNIRS).
Detailed description
The purpose of this study is to assess the influence of a dual-task (combined motor-cognitive task) on dual-task performance of a complex dynamic stability task in healthy young adults and to assess the effects of dual-task training on cognitive-motor learning and cortical activation in healthy young adults. A dual-task is defined as concurrent performance of two tasks, usually a cognitive and motor task, that can be performed independently and have distinct and separate goals. Individuals engage in dual tasks every day and must allocate attentional resources to each task. While recognition of susceptibility to performance decrements in dual-task settings may be difficult, increased dual-task complexity is associated with decreased performance in one or both tasks. The well documented effects of dual-task practice represent a promising approach to improve dual-task performance for clinical populations such as individuals with neurological conditions or older individuals, in which complex multitask situations can increase fall risk due to hindered balance and walking performance. Similarly, young adults have demonstrated performance decrements while executing a dual-task that involved a combined balance and cognitive task. Research of dual-task training in healthy young cohort has indicated significant improvements in both motor and cognitive task performance in dual-task situations, suggesting the efficiency of this intervention strategy. However, most of these studies have investigated effects of a simple postural task combined with cognitive task training on dual-task performance. Effects of dual-task training using a complex dynamic postural stability task on dual-task performance of such complex task is lacking. Moreover, existing studies demonstrate conflicting evidence of dual-task training effects among healthy young adults since improvements in the motor task only have been largely reported. It is crucial to understand dual-task training effects on performance of a complex cognitive-motor task since postural control involves complex integration of somatosensory, vestibular, and visual systems. Our experimental paradigm will challenge these systems; thus, findings of this study would inform our intervention strategies in a variety of populations ranging from athletes to individuals with neurological conditions.
Dynamic postural stability is an integral aspect of postural control and it involves complex interaction of prefrontal, somatosensory, vestibular, and visual systems. However, a motor task involving complex interaction of these systems combined with cognitive task challenges has not been investigated thoroughly. Moreover, neural activation within these cortical areas during dual-task performance and effects of dual-task training are largely unknown.
Since, coordinated control of the body requires integration of all these systems (i.e. prefrontal, somatosensory, vestibular, and visual), it is important to systemically study the interference of an additional attention-demanding task, such as an auditory stimulus reaction time task on interaction of these systems that may contribute to decreased postural stability. Moreover, it is important to investigate if training on such a complex dual-task can reduce motor-cognitive interference, improve postural stability, and optimize cortical activation in complex dual-task conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dual-task training | Experimental | Behavioral: Dual-task trainingDual-task training will consist of balancing on the dynamic stability platform and responding to auditory stimuli. Participants will perform 18 trials total in 3 blocks of 6 trials. Each trial will be 30 seconds (s) in duration followed by 30 s of rest (i.e. quiet standing on the platform while holding onto the rails.) Between each training block, the participant will step off the platform and rest for 2 minutes. Dual-task training will occur on consecutive visits 2-6. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy young adults
- Right-handed
Key exclusion criteria (6 listed)
- Individuals with cognitive deficits or communication problems
- Individuals with impaired vision
- Individuals with balance disorders such as vestibular disorders, etc.
- Individuals with known cardiorespiratory dysfunctions
- Individuals with presence of lower extremity condition, injury, or surgery within last 3 months which could compromise training
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual-task trainingSee descriptions under arm description. The dual-task training will occur across a total of 5 consecutive workday visits. | Behavioural | Dual-task training |
Primary outcome
Change in auditory reaction time task performance
Time frame: Baseline to 10 days, and upto 3 weeks. Shorter reaction time indicates better performance.
Average amount of time in seconds for a button press in response to an auditory tone
Change in balance task performance
Time frame: Baseline to 10 days, and upto 3 weeks
The average amount of time in seconds that a participant maintains the stability platform within 3 degrees of horizontal position during 6 trials of 30 sec each. The total score will range between 0-30 s. Higher balance score indicates better balance performance.
Change in dual-task performance
Time frame: Baseline to 10 days, and upto 3 weeks
Dual-task performance will assess performance on the combined auditory reaction time task and the balance task, i.e. performance under influence of dual-task situation.
Change in Cortical Activation
Time frame: Baseline to 10 days, and upto 3 weeks
The amount of change in cortical activity (change in oxyhemoglobin concentration in umol) within the prefrontal and sensorimotor cortices in response to dual-task training.
2 secondary outcomes
Errors in auditory reaction time task performance
Time frame: Baseline to 10 days, and upto 3 weeks
Balance variability
Time frame: Baseline to 10 days, and upto 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
- Background: PubMed 16095533Beauchet O, Dubost V, Herrmann FR, Kressig RW. Stride-to-stride variability while backward counting among healthy young adults. J Neuroeng Rehabil. 2005 Aug 11;2:26. doi: 10.1186/1743-0003-2-26.
- Background: PubMed 28149274Fraser SA, Li KZ, Berryman N, Desjardins-Crepeau L, Lussier M, Vadaga K, Lehr L, Minh Vu TT, Bosquet L, Bherer L. Does Combined Physical and Cognitive Training Improve Dual-Task Balance and Gait Outcomes in Sedentary Older Adults? Front Hum Neurosci. 2017 Jan 18;10:688. doi: 10.3389/fnhum.2016.00688. eCollection 2016.
- Background: PubMed 28356727Ghai S, Ghai I, Effenberg AO. Effects of dual tasks and dual-task training on postural stability: a systematic review and meta-analysis. Clin Interv Aging. 2017 Mar 23;12:557-577. doi: 10.2147/CIA.S125201. eCollection 2017.
- Background: PubMed 29593614Kiss R, Brueckner D, Muehlbauer T. Effects of Single Compared to Dual Task Practice on Learning a Dynamic Balance Task in Young Adults. Front Psychol. 2018 Mar 12;9:311. doi: 10.3389/fpsyg.2018.00311. eCollection 2018.
- Background: PubMed 30085354Pinti P, Tachtsidis I, Hamilton A, Hirsch J, Aichelburg C, Gilbert S, Burgess PW. The present and future use of functional near-infrared spectroscopy (fNIRS) for cognitive neuroscience. Ann N Y Acad Sci. 2020 Mar;1464(1):5-29. doi: 10.1111/nyas.13948. Epub 2018 Aug 7.
- Background: PubMed 31417220Techayusukcharoen R, Iida S, Aoki C. Observing brain function via functional near-infrared spectroscopy during cognitive program training (dual task) in young people. J Phys Ther Sci. 2019 Jul;31(7):550-555. doi: 10.1589/jpts.31.550. Epub 2019 Jul 9.
- Individual participant dataSharing planned: Yes. IPD will share after the completion of the study upon request to the PI.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Swati M Surkar, PhD principal investigator
East Carolina University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual-task training in people with Dual-task and Healthy Adults, run by East Carolina University at 1 site in United States.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 19 Jan 2022. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in auditory reaction time task performance (time frame: Baseline to 10 days, and upto 3 weeks. Shorter reaction time indicates better performance.). The study lists 4 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 NCT04666181, which also lists 6 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 19 Jan 2022.