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Autism Spectrum DisorderNCT06415539

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

A study testing classical physical therapy program and exercises in people with Autism Spectrum Disorder and Autism, run by Uskudar University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 6 to 10 yearsHealthy volunteers can take part
Conditions the study is for
Autism Spectrum Disorder, Autism
What is being tested?
classical physical therapy program and exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteTurkey (Türkiye)
Study dates
30 Nov 2022to 1 Nov 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 10 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Uskudar University

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Vestibular and Proprioceptive 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.

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.

Being tested
classical physical therapy program, exercises
Medical subject headings
Autism Spectrum Disorder, Autistic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • classical physical therapy programOther

    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.

  • exercisesOther

    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.

Study groups in NCT06415539
Study groupRoleWhat they receive
controlActive comparatorClassic physical therapy program will be applied
Receives: Other: classical physical therapy program
exerciseExperimentalIn addition to the classical physical therapy program, a treatment program including vestibular and proprioceptive exercise training will be applied.
Receives: Other: classical physical therapy program; Other: exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2024
  2. Study start30 Nov 2022
  3. Primary completion1 Nov 2023
  4. Study completion1 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06415539
Sponsor's protocol ID
Uskudar10
Status last verified
Jul 2024
First submitted
9 May 2024
Last updated
17 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing classical physical therapy program and exercises in people with Autism Spectrum Disorder and Autism, run by Uskudar University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postrotary Nystagmus Assessment Test (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06415539, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.

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