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Completed

NCT Number: NCT06415539

The Effect of Exercise Practices on Hyperactivity Levels in Children With Autism Spectrum Disorder

The aim of this study is to examine the effect of vestibular and proprioceptive exercise practices on the hyperactivity level in children with autism spectrum disorder.

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Key information

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uskudar University

Istanbul, Turkey (Türkiye)

About this study

The families of all children participating in the study will be informed and their written consent will be obtained. Vestibular and proprioceptive evaluation, hyperactivity evaluation and nystagmus evaluation will be applied to each child participating in the study twice, before and after treatment. Children will be divided into two groups: an exercise group and a control group, consisting of equal numbers of patients. A classical physical therapy program will be applied to both groups. In addition to the exercise group, a treatment program including vestibular and proprioceptive exercise training will be applied. The training program for both groups will be held in 40-minute sessions, 2 days a week for 8 weeks.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • children whose voluntary consent form is signed by their parents
  • Children ages 6 to 10
  • not using supplements
  • not having undergone any surgical operation

Exclusion criteria

  • children who have any obstacle to exercise
  • They were determined as children who could not cooperate in the study.

Treatment and study plan

classical physical therapy program

Other

Children in the control group, where classical physiotherapy and rehabilitation methods are applied, will continue their individual training programs with a physiotherapist for 40 minutes, 2 days a week, for 8 weeks.

Exercises

Other

Children in this group will be given vestibular and proprioceptive exercise training in addition to the classical physiotherapy program. Skateboard, swing, hammock, bowl, ball, sensory pads, ball pool, slide, climbing bar, trampoline and balance board will be used as materials in vestibular and proprioceptive exercise training. In addition, at the end of the training sessions, parents will be informed about the application of exercise training to daily activities.

Primary outcomes

  1. Postrotary Nystagmus Assessment Test

    Time frame: 8 weeks

    The most common diagnostic assessment for vestibular function includes use of the postrotary nystagmus test17 and clinical observation. The postrotary nystagmus test is used to identify whether a child has a vestibular disability During the test, the subject is seated on a rotation disk, with his or her head fixed in a 30-degree angle forward, to ensure that the semicircular canals are horizontal.19 Next, the subject is rotated for ten clockwise or counterclockwise rotations, at 2 seconds per rotation. The subject is asked to gaze forward with both eyes, and the examiner observes the degree of nystagmus produced by the rotations.

  2. Sensory Profile Test

    Time frame: 8 weeks

    Sensory Profile is a report-based questionnaire that is applied to measure the sensory processing abilities of children between the ages of 3-10 and to reveal the effects of the sensory processing process on the functional performance of children in their daily lives, and can determine children's sensory performances in detail. The survey can be applied to children with different types and degrees of disability. Mother, father or caregiver; That is, the evaluation is carried out by the people who are primarily responsible for the child's care by rating the 33 items in the survey according to their frequency. Items are scored as "always = 1, often = 2, sometimes = 3, rarely = 4, never = 5". Raw score totals for each section and factor in the survey. Higher scores indicate a higher frequency of specific sensory responses.

  3. Vanderbilt Assessment Scale

    Time frame: 8 weeks

    Both parent and teacher assessment scales have two components: symptom assessment and impairment in performance. The symptom assessment component screens for symptoms relevant to inattentive and hyperactive ADHD subtypes. To meet criteria for ADHD diagnoses, one must have 6 positive responses to either the core 9 inattentive symptoms or core 9 hyperactive symptoms, or both.

    A positive response is either a score of 2 or 3 ("often" to "very often"). The final 8 questions of both versions ask the respondent to rate the child's performance in school and his or her interactions with others on a 1-5 scale, with 1-2 meaning "above average", 3 meaning "average", and 4-5 meaning "problematic".

    To meet the criteria for ADHD, there must be at least one score for the performance set that is a 5, or two scores that are at least 4, as these scores indicate impairment in performance.

Sponsors and collaborators

Lead sponsor

Uskudar University

Other

Registry information

Official study title

The Effect of Vestibular and Proprioceptive Exercise Practices on Hyperactivity Levels in Children With Autism Spectrum Disorder

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 16, 2024
Registry last updated
Jul 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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