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Influence of Aerobic Exercise on Inhibitory Control of Excutive Function in Spastic Hemiplegic C.P

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04154566
Recruitment Status : Completed
First Posted : November 6, 2019
Last Update Posted : December 3, 2019
Sponsor:
Information provided by (Responsible Party):
Mohammed E. Ali, Ph. D Candidate., South Valley University

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

Condition or disease Intervention/treatment Phase
Spastic Hemiplegic Cerebral Palsy Other: Aerobic Exercises Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Single (Outcomes Assessor)
Masking Description: Blinding process to participants and care providers was impossible due to the nature of intervention therapy. Data were analyzed by an impartial statistician (outcomes assessor), referring to each arm with an encoded name: Group A (control group) and Group B (study group).
Primary Purpose: Treatment
Official Title: Influence of Aerobic Exercise on Inhibitory Control of Excutive Function in Spastic Hemiplegic Cerebral Palsy: A Randomized Controlled Trail
Actual Study Start Date : April 1, 2019
Actual Primary Completion Date : July 1, 2019
Actual Study Completion Date : August 1, 2019


Arm Intervention/treatment
Experimental: the study group
Group (A) the study group received aerobic exercise in addition to selected physical therapy program which contain strengthening exercises for upper limb and lower limb muscles, stretching exercises for elbow extensors, hand supinator, wrist extensors, knee extensors and ankle dorsiflexors, balancing exercises, coordination exercises and gait training exercises in open environment.
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

No Intervention: the control group
group (B) the control group received the same selected physical therapy program which contain strengthening exercises for upper limb and lower limb muscles, stretching exercises for elbow extensors, hand supinator, wrist extensors, knee extensors and ankle dorsiflexors, balancing exercises, coordination exercises and gait training exercises in open environment only.



Primary Outcome Measures :
  1. The mean values of the Flanker test accuracy, congrunent reaction time and incongruent reaction time [ Time Frame: Eriksen flanker test was assessed at day 0, 90. ]
    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).

  2. The mean values of the Stroop test accuracy, congrunent reaction time and incongruent reaction time [ Time Frame: Stroop Color-Word test was assessed at day 0, 90. ]
    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.



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Ages Eligible for Study:   7 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04154566


Locations
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Egypt
South Valley University, Faculty of Physical Therapy
Qina, Egypt, 83523
Sponsors and Collaborators
South Valley University
Investigators
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Principal Investigator: Nehad A. Abo-zaid, PhD South Valley University, Faculty of Physical Therapy
Principal Investigator: Mohammed E. Ali, PhD student South Valley University, Faculty of Physical Therapy
  Study Documents (Full-Text)

Documents provided by Mohammed E. Ali, Ph. D Candidate., South Valley University:
Publications of Results:

Other Publications:
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Responsible Party: Mohammed E. Ali, Ph. D Candidate., Lecturer, South Valley University
ClinicalTrials.gov Identifier: NCT04154566    
Other Study ID Numbers: P. T. REC/012/002278
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohammed E. Ali, Ph. D Candidate., South Valley University:
Hemiplegic cerebral palsy
inhibitory control of executive functions.
aerobic exercise.
Additional relevant MeSH terms:
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Muscle Spasticity
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations