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The Effect of Physical Activity Autonomic Response of Autism Spectrum

U

University of Jazan

Status

Completed

Conditions

Neurodevelopmental Disorders

Treatments

Other: Physical Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT05725733
2265749561

Details and patient eligibility

About

This study will investigate the effect of physical activity on autism spectrum disorder (ASD) in individuals with ASD of different age groups through measuring the hemodynamic, heart activity and respiratory system parameters.

Full description

One hundred participants will be included in this study. One hundred typically developed children or control group and one hundred children with ASD group. The age range of participants will be 4 - 18 years old. The participants in both control and ASD groups will be randomly divided into 4 subgroups according to their age (4-7 years old, 7-10 years old, 10-13 years old and, 14-18 years old). Also, ASD group will be categorized according to the symptoms severity using the childhood autism rating scale (CARS). Participants will be excluded if they have any intellectual disability (IQ ≤ 70), co-morbid medical or psychiatric disorders, pervasive developmental disorders (PDD) or Attention-deficit hyperactivity disorders (ADHD). They will also be excluded if they are taking any medications which to affect cardiovascular system, respiratory system, or arousal and balance or any other contraindications to exercises. Wechsler Intelligence Scale for Children-Fourth Edition24 will be used to assess the Intelligence Quotient (IQ).

Enrollment

200 patients

Sex

All

Ages

4 to 18 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Children with ASD group with the age range of participants will be 4 - 18 years old
  2. Typically developed children with the age range of participants will be 4 - 18 years old

Exclusion criteria

Participants will be excluded if they have the following:

  • any intellectual disability (IQ ≤ 70)
  • co-morbid medical or psychiatric disorders.
  • pervasive developmental disorders (PDD) or Attention-deficit hyperactivity disorders (ADHD).
  • They will also be excluded if they are taking any medications which to affect cardiovascular system, respiratory system, or arousal and balance or any other contraindications to exercises.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

children with ASD group.
Experimental group
Description:
ASD groups will be randomly divided into 4 subgroups according to their age (4-7 years old, 7-10 years old, 10-13 years old and, 14-18 years old). Also, ASD group will be categorized according to the symptoms severity using the childhood autism rating scale (CARS).
Treatment:
Other: Physical Therapy
One hundred typically developed children or control group
Active Comparator group
Description:
They will be randomly divided into 4 subgroups according to their age (4-7 years old, 7-10 years old, 10-13 years old and, 14-18 years old)
Treatment:
Other: Physical Therapy

Trial contacts and locations

1

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Central trial contact

Wafaa M Amin; Mohamed M Ahmed

Data sourced from clinicaltrials.gov

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