NCT04757844

Brief Summary

Attention may influence the motor performance and frontal activity. This study will examine the effect of different attentional focus : internal, external and divided attention (dual task) on prefrontal cortical activation (fNIRS) and on gait performance. Thirty young healthy voluntary adults will participate in this study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable healthy

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

February 9, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

February 12, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 17, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2021

Completed
Last Updated

September 1, 2021

Status Verified

August 1, 2021

Enrollment Period

2 months

First QC Date

February 9, 2021

Last Update Submit

August 31, 2021

Conditions

Healthy

Keywords

near infrared spectroscopyprefrontal cortexattentiongait

Outcome Measures

Primary Outcomes (2)

  • Effects of different attentional conditions on hemodynamic response in prefrontal cortex

    Oxyhemoglobin variations in prefrontal cortex measured with fNIRS

    Baseline

  • Effects of different attentional conditions on hemodynamic response in prefrontal cortex

    Deoxyhemoglobin variations in prefrontal cortex measured with fNIRS

    Baseline

Secondary Outcomes (4)

  • Effects of speed on gait.

    Baseline

  • Effects of cadence on gait.

    Baseline

  • Effects of stride length on gait.

    Baseline

  • Effects of double support time on gait.

    Baseline

Study Arms (1)

Young healthy voluntary adults

EXPERIMENTAL

30 young healthy voluntary adults

Device: Functional Near-Infrared Spectroscopy (fNIRS)

Interventions

Functional Near-Infrared Spectroscopy (fNIRS)DEVICE

The hemodynamic response in prefrontal cortex will be measured using an Octamon+ system (Artinis). Eight emission and two detector probes will be arranged on the participant's forehead.

Young healthy voluntary adults

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Man or woman
  • years old
  • Informed consent obtained
  • Free from any neurological, cardiologic, rheumatologic disorders.

You may not qualify if:

  • Assisted walker.
  • Disorders affecting gait.
  • Concomitant medication likely to interfere with the results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHR Orléans

Orléans, 45067, France

Location

Related Publications (13)

  • Wulf G, Hoss M, Prinz W. Instructions for motor learning: differential effects of internal versus external focus of attention. J Mot Behav. 1998 Jun;30(2):169-79. doi: 10.1080/00222899809601334.

    PMID: 20037032BACKGROUND

  • Kim SA, Ryu YU, Shin HK. The effects of different attentional focus on poststroke gait. J Exerc Rehabil. 2019 Aug 28;15(4):592-596. doi: 10.12965/jer.1938360.180. eCollection 2019 Aug.

    PMID: 31523682BACKGROUND

  • Lu CF, Liu YC, Yang YR, Wu YT, Wang RY. Maintaining Gait Performance by Cortical Activation during Dual-Task Interference: A Functional Near-Infrared Spectroscopy Study. PLoS One. 2015 Jun 16;10(6):e0129390. doi: 10.1371/journal.pone.0129390. eCollection 2015.

    PMID: 26079605BACKGROUND

  • Herold F, Wiegel P, Scholkmann F, Thiers A, Hamacher D, Schega L. Functional near-infrared spectroscopy in movement science: a systematic review on cortical activity in postural and walking tasks. Neurophotonics. 2017 Oct;4(4):041403. doi: 10.1117/1.NPh.4.4.041403. Epub 2017 Aug 1.

    PMID: 28924563BACKGROUND

  • Farid L, Jacobs D, Do Santos J, Simon O, Gracies JM, Hutin E. FeetMe(R) Monitor-connected insoles are a valid and reliable alternative for the evaluation of gait speed after stroke. Top Stroke Rehabil. 2021 Mar;28(2):127-134. doi: 10.1080/10749357.2020.1792717. Epub 2020 Jul 13.

    PMID: 32654627BACKGROUND

  • Kal EC, van der Kamp J, Houdijk H. External attentional focus enhances movement automatization: a comprehensive test of the constrained action hypothesis. Hum Mov Sci. 2013 Aug;32(4):527-39. doi: 10.1016/j.humov.2013.04.001. Epub 2013 Jun 30.

    PMID: 24054892BACKGROUND

  • Yogev-Seligmann G, Hausdorff JM, Giladi N. The role of executive function and attention in gait. Mov Disord. 2008 Feb 15;23(3):329-42; quiz 472. doi: 10.1002/mds.21720.

    PMID: 18058946BACKGROUND

  • Wood JN, Grafman J. Human prefrontal cortex: processing and representational perspectives. Nat Rev Neurosci. 2003 Feb;4(2):139-47. doi: 10.1038/nrn1033. No abstract available.

    PMID: 12563285BACKGROUND

  • Pelicioni PHS, Tijsma M, Lord SR, Menant J. Prefrontal cortical activation measured by fNIRS during walking: effects of age, disease and secondary task. PeerJ. 2019 May 3;7:e6833. doi: 10.7717/peerj.6833. eCollection 2019.

    PMID: 31110922BACKGROUND

  • Shafizadeh M, Platt GK, Mohammadi B. Effects of different focus of attention rehabilitative training on gait performance in Multiple Sclerosis patients. J Bodyw Mov Ther. 2013 Jan;17(1):28-34. doi: 10.1016/j.jbmt.2012.04.005. Epub 2012 May 10.

    PMID: 23294680BACKGROUND

  • Yogev-Seligmann G, Rotem-Galili Y, Mirelman A, Dickstein R, Giladi N, Hausdorff JM. How does explicit prioritization alter walking during dual-task performance? Effects of age and sex on gait speed and variability. Phys Ther. 2010 Feb;90(2):177-86. doi: 10.2522/ptj.20090043. Epub 2009 Dec 18.

    PMID: 20023000BACKGROUND

  • Holtzer R, Mahoney JR, Izzetoglu M, Izzetoglu K, Onaral B, Verghese J. fNIRS study of walking and walking while talking in young and old individuals. J Gerontol A Biol Sci Med Sci. 2011 Aug;66(8):879-87. doi: 10.1093/gerona/glr068. Epub 2011 May 17.

    PMID: 21593013BACKGROUND

  • Udina C, Avtzi S, Durduran T, Holtzer R, Rosso AL, Castellano-Tejedor C, Perez LM, Soto-Bagaria L, Inzitari M. Functional Near-Infrared Spectroscopy to Study Cerebral Hemodynamics in Older Adults During Cognitive and Motor Tasks: A Review. Front Aging Neurosci. 2020 Jan 21;11:367. doi: 10.3389/fnagi.2019.00367. eCollection 2019.

    PMID: 32038224BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2021

First Posted

February 17, 2021

Study Start

February 12, 2021

Primary Completion

April 19, 2021

Study Completion

April 19, 2021

Last Updated

September 1, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)