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

Sponsor
South Valley University (Other)
Overall Status
Completed
CT.gov ID
NCT04154566
Collaborator
(none)
60
1
2
4
15

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Aerobic Exercises
N/A

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.

Study Design

Study Type:
Interventional
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.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 :
Apr 1, 2019
Actual Primary Completion Date :
Jul 1, 2019
Actual Study Completion Date :
Aug 1, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. The mean values of the Flanker test accuracy, congrunent reaction time and incongruent reaction time [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years to 11 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 South Valley University, Faculty of Physical Therapy Qina Egypt 83523

Sponsors and Collaborators

  • South Valley University

Investigators

  • 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)

More Information

Publications

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:
Nov 6, 2019
Last Update Posted:
Dec 3, 2019
Last Verified:
Nov 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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., Lecturer, South Valley University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 3, 2019