- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04757844
Attentional Focus and Prefrontal Cortical Activation (AttNIRS)
August 31, 2021 updated by: Centre Hospitalier Régional d'Orléans
The Effects of Different Attentional Focus During Walking on Prefrontal Cortical Activation in Young Healthy Adults
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The subjects will be guided to walk at a normal pace while maintaining the required attentional focus.
They will walk on 30 m five times in each of the four different focus conditions :1) no instructions about the attentional focus 2) internal focus on their feet movements, 3) external focus on two lines drawn on the floor, 4) divided attention (walking while performing an arithmetic task).
A fNIRS system will be used for the prefrontal cortex activation evaluation and FeetMe soles for gait analyses.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Orléans, France, 45067
- CHR Orléans
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Man or woman
- 18 -30 years old
- Informed consent obtained
- Free from any neurological, cardiologic, rheumatologic disorders.
Exclusion Criteria:
- Assisted walker.
- Disorders affecting gait.
- Concomitant medication likely to interfere with the results.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Young healthy voluntary adults
30 young healthy voluntary adults
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effects of different attentional conditions on hemodynamic response in prefrontal cortex
Time Frame: Baseline
|
Oxyhemoglobin variations in prefrontal cortex measured with fNIRS
|
Baseline
|
|
Effects of different attentional conditions on hemodynamic response in prefrontal cortex
Time Frame: Baseline
|
Deoxyhemoglobin variations in prefrontal cortex measured with fNIRS
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effects of speed on gait.
Time Frame: Baseline
|
Gait parameters will be measured with connected soles FeetMe ® : speed
|
Baseline
|
|
Effects of cadence on gait.
Time Frame: Baseline
|
Gait parameters will be measured with connected soles FeetMe ® : cadence
|
Baseline
|
|
Effects of stride length on gait.
Time Frame: Baseline
|
Gait parameters will be measured with connected soles FeetMe ® : stride length
|
Baseline
|
|
Effects of double support time on gait.
Time Frame: Baseline
|
Gait parameters will be measured with connected soles FeetMe ® : double support time
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 12, 2021
Primary Completion (ACTUAL)
April 19, 2021
Study Completion (ACTUAL)
April 19, 2021
Study Registration Dates
First Submitted
February 9, 2021
First Submitted That Met QC Criteria
February 12, 2021
First Posted (ACTUAL)
February 17, 2021
Study Record Updates
Last Update Posted (ACTUAL)
September 1, 2021
Last Update Submitted That Met QC Criteria
August 31, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- CHRO 2020-22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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