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CompletedNCT06415539Updated Jul 17, 2024

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

An interventional study of classical physical therapy program and exercises in Autism Spectrum Disorder and Autism, sponsored by Uskudar University. Completed at 1 site in Turkey. Open to participants aged 6 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-17.

Sponsored by Uskudar University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 5 months after the study started (first participant enrolled Nov 2022, registered May 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
6 Years to 10 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

03

In context

Autistic Disorder

1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.

This study's enrollment of 22 is below the median of 45 across 1,044 interventional studies indexed under Autistic Disorder.

Browse Autistic Disorder studies →

Lead sponsor

Uskudar University is the lead sponsor of 164 studies on the registry; 35 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
22 participants (actual)

Study arms

  • Active comparator
    control

    Classic physical therapy program will be applied

    Other: classical physical therapy program

  • Experimental
    exercise

    In addition to the classical physical therapy program, a treatment program including vestibular and proprioceptive exercise training will be applied.

    Other: classical physical therapy program · Other: exercises

Interventions

  • Otherclassical physical therapy program

    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.

  • Otherexercises

    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.

06

What researchers measure

Primary outcomes

  1. Postrotary Nystagmus Assessment Test

    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.

    Time frame: 8 weeks

  2. Sensory Profile Test

    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.

    Time frame: 8 weeks

  3. Vanderbilt Assessment Scale

    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.

    Time frame: 8 weeks

07

Study locations

1 site
  • Uskudar University
    Istanbul, Turkey
08

References and documents

Publications

  • Tse CYA, Lee HP, Chan KSK, Edgar VB, Wilkinson-Smith A, Lai WHE. Examining the impact of physical activity on sleep quality and executive functions in children with autism spectrum disorder: A randomized controlled trial. Autism. 2019 Oct;23(7):1699-1710. doi: 10.1177/1362361318823910. Epub 2019 Jan 20. PubMed 30663324 ↗
  • Xiao N, Shinwari K, Kiselev S, Huang X, Li B, Qi J. Effects of Equine-Assisted Activities and Therapies for Individuals with Autism Spectrum Disorder: Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2023 Feb 1;20(3):2630. doi: 10.3390/ijerph20032630. PubMed 36767996 ↗
  • Kashefimehr B, Kayihan H, Huri M. The Effect of Sensory Integration Therapy on Occupational Performance in Children With Autism. OTJR (Thorofare N J). 2018 Apr;38(2):75-83. doi: 10.1177/1539449217743456. Epub 2017 Dec 27. PubMed 29281930 ↗
  • Padmanabha H, Singhi P, Sahu JK, Malhi P. Home-based Sensory Interventions in Children with Autism Spectrum Disorder: A Randomized Controlled Trial. Indian J Pediatr. 2019 Jan;86(1):18-25. doi: 10.1007/s12098-018-2747-4. Epub 2018 Jul 25. PubMed 30043192 ↗
  • Lord C, Elsabbagh M, Baird G, Veenstra-Vanderweele J. Autism spectrum disorder. Lancet. 2018 Aug 11;392(10146):508-520. doi: 10.1016/S0140-6736(18)31129-2. Epub 2018 Aug 2. PubMed 30078460 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06415539
Lead sponsor
Uskudar University
Responsible party
Dr. Öğr. Üyesi Ömer Şevgin (Asst. Prof. Dr., Uskudar University) — Principal investigator
First posted
May 16, 2024
Start date
Nov 30, 2022
Primary completion
Nov 1, 2023
Completion
Nov 1, 2023
Last update
Jul 17, 2024

Study contacts

Evren ERİK
study chair · Uskudar University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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