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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06415539
• Other study ID #: Uskudar10
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2024
• Est. completion date: July 30, 2024

Study information

• Verified date: May 2024
• Source: Uskudar University
• Contact: Ömer SEVGIN
• Phone: +905069787535
• Email: omer.sevgin[@]uskudar.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: July 30, 2024
• Est. primary completion date: July 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism
• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Other:
• classical 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.
• exercises
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.

Locations

Country	Name	City	State
Turkey	Uskudar University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Uskudar University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 weeks
Primary	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.	8 weeks
Primary	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.	8 weeks