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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04757844
Other study ID # CHRO 2020-22
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 12, 2021
Est. completion date April 19, 2021

Study information

Verified date August 2021
Source Centre Hospitalier Régional d'Orléans
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date April 19, 2021
Est. primary completion date April 19, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Functional Near-Infrared Spectroscopy (fNIRS)
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.

Locations

Country Name City State
France CHR Orléans Orléans

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Régional d'Orléans

Country where clinical trial is conducted

France, 

References & Publications (13)

Farid L, Jacobs D, Do Santos J, Simon O, Gracies JM, Hutin E. FeetMe® 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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Wood JN, Grafman J. Human prefrontal cortex: processing and representational perspectives. Nat Rev Neurosci. 2003 Feb;4(2):139-47. Review. — View Citation

Wulf G, Höß 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. — View Citation

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. Review. — View Citation

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. — View Citation

* Note: There are 13 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Effects of different attentional conditions on hemodynamic response in prefrontal cortex Oxyhemoglobin variations in prefrontal cortex measured with fNIRS Baseline
Primary Effects of different attentional conditions on hemodynamic response in prefrontal cortex Deoxyhemoglobin variations in prefrontal cortex measured with fNIRS Baseline
Secondary Effects of speed on gait. Gait parameters will be measured with connected soles FeetMe ® : speed Baseline
Secondary Effects of cadence on gait. Gait parameters will be measured with connected soles FeetMe ® : cadence Baseline
Secondary Effects of stride length on gait. Gait parameters will be measured with connected soles FeetMe ® : stride length Baseline
Secondary Effects of double support time on gait. Gait parameters will be measured with connected soles FeetMe ® : double support time Baseline
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