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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04154566
Other study ID # P. T. REC/012/002278
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2019
Est. completion date August 1, 2019

Study information

Verified date November 2019
Source South Valley University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study was conducted to assess the influence of aerobic exercise on inhibitory control of executive functions in spastic hemiplegic cerebral palsy.


Description:

Inhibitory control of executive functions (EF) is one of the main specific cognitive impairments that affect children with cerebral palsy, cognitive skills begin to develop in infancy and continuing through the pre-school years, childhood and into adolescence it changes across the lifespan of an individual and has great effect on their participation and quality of life. The aim of study was to assess the influence of aerobic exercise on inhibitory control of executive functions in spastic hemiplegic cerebral palsy. Sixty children with spastic hemiplegic cerebral palsy were enrolled in this study and were assessed for eligibility. Their aged ranged from seven and eleven years. They were assigned randomly into two equal groups. Group (A) the study group received aerobic exercise in addition to selected physical therapy program. And group (B) the control group received the same selected physical therapy program only. The treatment was conducted for one hour, three times / weak for three successful months. Eriksen flanker test and Stroop Color-Word test were used to assess inhibitory control of EF pre and post treatment.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date August 1, 2019
Est. primary completion date July 1, 2019
Accepts healthy volunteers No
Gender All
Age group 7 Years to 11 Years
Eligibility Inclusion Criteria:

- Their aged ranged from seven and eleven years.

- they were from both sexes.

- they have left side hemiplegic cerebral palsy.

- they were able to walk independently.

Exclusion Criteria:

- children with visual or auditory problems.

- children with history of drug intake that may affect the cognitive function.

- medically unstable children especially with cardiovascular disorders.

- uncooperative children.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Aerobic Exercises
Aerobic exercise refers to exercise that involves or improves oxygen consumption by the body. It is the type of activity that uses large muscle groups. Its performance is in a continuous and rhythmic way with a main goal to make the heart and lungs work harder than they do when the person at rest

Locations

Country Name City State
Egypt South Valley University, Faculty of Physical Therapy Qina

Sponsors (1)

Lead Sponsor Collaborator
South Valley University

Country where clinical trial is conducted

Egypt, 

References & Publications (15)

Arner M, Eliasson AC, Nicklasson S, Sommerstein K, Hägglund G. Hand function in cerebral palsy. Report of 367 children in a population-based longitudinal health care program. J Hand Surg Am. 2008 Oct;33(8):1337-47. doi: 10.1016/j.jhsa.2008.02.032. — View Citation

Boyd RN, Davies PS, Ziviani J, Trost S, Barber L, Ware R, Rose S, Whittingham K, Sakzewski L, Bell K, Carty C, Obst S, Benfer K, Reedman S, Edwards P, Kentish M, Copeland L, Weir K, Davenport C, Brooks D, Coulthard A, Pelekanos R, Guzzetta A, Fiori S, Wyn — View Citation

Chang YK, Labban JD, Gapin JI, Etnier JL. The effects of acute exercise on cognitive performance: a meta-analysis. Brain Res. 2012 May 9;1453:87-101. doi: 10.1016/j.brainres.2012.02.068. Epub 2012 Mar 4. Erratum in: Brain Res. 2012 Aug 27;1470:159. — View Citation

Garne E, Dolk H, Krägeloh-Mann I, Holst Ravn S, Cans C; SCPE Collaborative Group. Cerebral palsy and congenital malformations. Eur J Paediatr Neurol. 2008 Mar;12(2):82-8. Epub 2007 Sep 19. Review. — View Citation

Gellish RL, Goslin BR, Olson RE, McDonald A, Russi GD, Moudgil VK. Longitudinal modeling of the relationship between age and maximal heart rate. Med Sci Sports Exerc. 2007 May;39(5):822-9. — View Citation

Hielkema T, Hadders-Algra M. Motor and cognitive outcome after specific early lesions of the brain - a systematic review. Dev Med Child Neurol. 2016 Mar;58 Suppl 4:46-52. doi: 10.1111/dmcn.13047. Review. — View Citation

Holmefur M, Kits A, Bergström J, Krumlinde-Sundholm L, Flodmark O, Forssberg H, Eliasson AC. Neuroradiology can predict the development of hand function in children with unilateral cerebral palsy. Neurorehabil Neural Repair. 2013 Jan;27(1):72-8. doi: 10.1 — View Citation

Kluding PM, Tseng BY, Billinger SA. Exercise and executive function in individuals with chronic stroke: a pilot study. J Neurol Phys Ther. 2011 Mar;35(1):11-7. doi: 10.1097/NPT.0b013e318208ee6c. — View Citation

McClelland MM, Cameron CE, Duncan R, Bowles RP, Acock AC, Miao A, Pratt ME. Predictors of early growth in academic achievement: the head-toes-knees-shoulders task. Front Psychol. 2014 Jun 17;5:599. doi: 10.3389/fpsyg.2014.00599. eCollection 2014. — View Citation

McMorris T, Hale BJ. Differential effects of differing intensities of acute exercise on speed and accuracy of cognition: a meta-analytical investigation. Brain Cogn. 2012 Dec;80(3):338-51. doi: 10.1016/j.bandc.2012.09.001. Epub 2012 Oct 11. — View Citation

Pereira AC, Huddleston DE, Brickman AM, Sosunov AA, Hen R, McKhann GM, Sloan R, Gage FH, Brown TR, Small SA. An in vivo correlate of exercise-induced neurogenesis in the adult dentate gyrus. Proc Natl Acad Sci U S A. 2007 Mar 27;104(13):5638-43. Epub 2007 — View Citation

Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14. Erratum in: Dev Med Child Neurol. 2007 Jun;49(6): — View Citation

Sutoo D, Akiyama K. Regulation of brain function by exercise. Neurobiol Dis. 2003 Jun;13(1):1-14. Review. — View Citation

Wecker NS, Kramer JH, Wisniewski A, Delis DC, Kaplan E. Age effects on executive ability. Neuropsychology. 2000 Jul;14(3):409-14. — View Citation

Wolf SA, Kronenberg G, Lehmann K, Blankenship A, Overall R, Staufenbiel M, Kempermann G. Cognitive and physical activity differently modulate disease progression in the amyloid precursor protein (APP)-23 model of Alzheimer's disease. Biol Psychiatry. 2006 — View Citation

* Note: There are 15 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary The mean values of the Flanker test accuracy, congrunent reaction time and incongruent reaction time the Eriksen flanker task is a set of response inhibition tests used to assess the ability to suppress responses that are inappropriate in a particular context. The target is flanked by non-target stimuli which correspond either to the same directional response as the target (congruent flankers), to the opposite response (incongruent flankers), or to neither (neutral flankers). Eriksen flanker test was assessed at day 0, 90.
Primary The mean values of the Stroop test accuracy, congrunent reaction time and incongruent reaction time The Stroop Color and Word Test (SCWT) is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute, well-known as the Stroop Effect. Stroop Color-Word test was assessed at day 0, 90.
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