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

NCT ID: NCT06415539

Last Updated: 2024-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-30

Study Completion Date

2023-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Autism Spectrum Disorder Autism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

control

Classic physical therapy program will be applied

Group Type ACTIVE_COMPARATOR

classical physical therapy program

Intervention Type 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.

exercise

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

Group Type EXPERIMENTAL

classical physical therapy program

Intervention Type 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

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Uskudar University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. Öğr. Üyesi Ömer Şevgin

Asst. Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Evren ERİK

Role: STUDY_CHAIR

Uskudar University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Uskudar University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 30663324 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36767996 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29281930 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30043192 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30078460 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Uskudar10

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.