NCT04666181

Brief 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 functional near infrared spectroscopy (fNIRS).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 14, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

January 15, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

January 19, 2022

Status Verified

January 1, 2022

Enrollment Period

8 months

First QC Date

November 23, 2020

Last Update Submit

January 15, 2022

Conditions

Keywords

CognitionMotorDual-taskPrefrontal cortexSensorimotor cortex

Outcome Measures

Primary Outcomes (4)

  • Change in auditory reaction time task performance

    Average amount of time in seconds for a button press in response to an auditory tone

    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.

    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.

    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.

    Baseline to 10 days, and upto 3 weeks

Secondary Outcomes (2)

  • Errors in auditory reaction time task performance

    Baseline to 10 days, and upto 3 weeks

  • Balance variability

    Baseline to 10 days, and upto 3 weeks

Study Arms (1)

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.

Behavioral: Dual-task training

Interventions

See descriptions under arm description. The dual-task training will occur across a total of 5 consecutive workday visits.

Dual-task training

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy young adults
  • Right-handed

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

East Carolina University

Greenville, North Carolina, 27834, United States

Location

Related Publications (6)

  • 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.

    PMID: 16095533BACKGROUND
  • Fraser 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.

    PMID: 28149274BACKGROUND
  • Ghai 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.

    PMID: 28356727BACKGROUND
  • Kiss 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.

    PMID: 29593614BACKGROUND
  • Pinti 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.

    PMID: 30085354BACKGROUND
  • Techayusukcharoen 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.

    PMID: 31417220BACKGROUND

Study Officials

  • Swati M Surkar, PhD

    East Carolina University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 23, 2020

First Posted

December 14, 2020

Study Start

January 15, 2021

Primary Completion

August 30, 2021

Study Completion

November 30, 2021

Last Updated

January 19, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will share

IPD will share after the completion of the study upon request to the PI.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Data will be available immediately after completion of the study.

Locations