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NCT05908357Completed

Study of Two Exercises Protocols for Autism Spectrum Disorder

Effects of Exergaming on Gait and Fall Risk in Children With Autism Spectrum Disorder (ASD): A Randomized Controlled Clinical Trial

Source: ClinicalTrials.gov · Last updated 13 Apr 2025

Brief summary (registry, in English)

Introduction: Autism Spectrum Disorder (ASD) is characterized as a neurodevelopmental disorder, with motor symptoms that may predispose to falls and gait changes. Exercises through virtual reality (exergaming) showed good results in children with ASD, but no studies were found that evaluated the effects of exergaming on gait and the risk of falls. Objective: To evaluate the effects of exergaming on motor performance during gait and the risk of falls in children with ASD. Method: Pilot study of a clinical trial. There will be 22 participants, diagnosed with ASD, level I or II; age: 5 to 9 years old; that they do not use medications that interfere with postural balance and falls; without physiotherapy care for at least 2 months. They will be divided into Exergaming Group (EG, n=11) and Control Group (GC, n=11). The GC will receive guidance through booklets. The EG will be submitted to a treatment with exergaming for 3 months, with 2 weekly sessions of 45 min each (initial 10 min, 25-30 of exergaming with the Xbox360 console with Kinect sensor and game "Kinect Adventures!", 5 min of cool down ). They will be assessed using CARS-BR (Childhood Autism Rating Scale - Brazilian version), DCDQ (Developmental Coordination Disorder Questionnaire), EEP (Pediatric Equilibrium Scale), a semi-structured questionnaire to assess the history of falls and prevalence of falls, an adapted motivational scale for ASD, a satisfaction survey, and three-dimensional assessment of gait through the Gait Laboratory. Descriptive analysis will be performed and continuous variables will be summarized in mean and standard deviation, and categorical variables in absolute and relative frequencies. To compare the independent and paired variables, parametric tests will be used and a significance level of 5% will be considered (p \<0.05). Pearson's correlation will be used to assess correlations between continuous variables and the Chi square test to assess the relationship between categorical variables. Expected results: It is expected that children from the EG will obtain better results than the CG on gait variables and the risk of falling, with clinical and statistical significance.

Status (registry)
Completed
Study type
Interventional
Enrollment
22 (actual)
First submitted
29 May 2023
Start date
25 Aug 2023
Primary completion date
31 Dec 2024
Lead sponsor
Federal University of Bahia
Diseases
Autism
NCT number
NCT05908357

What you commit to

  • Study type: Interventional
  • Participants enrolled: 22
  • From 25 Aug 2023 to the primary completion date, 31 Dec 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Children with genetic syndromes duly diagnosed in association with ASD, based on the medical report;
  • Physical disability, respiratory disease, or cardiac complications that prevent exercise;
  • With a history of epilepsy/seizures in the last six months and without the use of specific medication;

Other

  • Proven hearing or visual loss without the use of hearing aids or eyeglasses respectively;
  • Children who, even with the formal consent of those responsible for them, do not accept to participate in the research.

Who the study is looking for

  • Children with ASD levels I or II;
  • Age 5 to 9 years
  • No use of medications that interfere with balance and falls;
  • Who have not been undergoing physiotherapeutic care in the last 2 months
  • Who present some gait alteration.

Age in the registry: 5 years to 9 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Instituto Baiano de Reabilitação - Fundação José Silveira
Coordinator of this site? Confirm its status
SalvadorBrazilUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.