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

Primary Purpose

Spastic Hemiplegic Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Aerobic Exercises
Sponsored by
South Valley University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spastic Hemiplegic Cerebral Palsy focused on measuring Hemiplegic cerebral palsy, inhibitory control of executive functions., aerobic exercise.

Eligibility Criteria

7 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • South Valley University, Faculty of Physical Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

the study group

the control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

Full Information

First Posted
November 4, 2019
Last Updated
November 28, 2019
Sponsor
South Valley University
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1. Study Identification

Unique Protocol Identification Number
NCT04154566
Brief Title
Influence of Aerobic Exercise on Inhibitory Control of Excutive Function in Spastic Hemiplegic C.P
Official Title
Influence of Aerobic Exercise on Inhibitory Control of Excutive Function in Spastic Hemiplegic Cerebral Palsy: A Randomized Controlled Trail
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
August 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Valley University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spastic Hemiplegic Cerebral Palsy
Keywords
Hemiplegic cerebral palsy, inhibitory control of executive functions., aerobic exercise.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
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).
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
the study group
Arm Type
Experimental
Arm Description
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.
Arm Title
the control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Aerobic Exercises
Intervention Description
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
Primary Outcome Measure Information:
Title
The mean values of the Flanker test accuracy, congrunent reaction time and incongruent reaction time
Description
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).
Time Frame
Eriksen flanker test was assessed at day 0, 90.
Title
The mean values of the Stroop test accuracy, congrunent reaction time and incongruent reaction time
Description
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.
Time Frame
Stroop Color-Word test was assessed at day 0, 90.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nehad A. Abo-zaid, PhD
Organizational Affiliation
South Valley University, Faculty of Physical Therapy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammed E. Ali, PhD student
Organizational Affiliation
South Valley University, Faculty of Physical Therapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Valley University, Faculty of Physical Therapy
City
Qina
ZIP/Postal Code
83523
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
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Citation
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Influence of Aerobic Exercise on Inhibitory Control of Excutive Function in Spastic Hemiplegic C.P

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