Study of Two Exercises Protocols for Autism Spectrum Disorder

Study Overview
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Brief Summary
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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.

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

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Other: Exergaming
* Other: Booklet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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; Proven hearing or visual loss without the use of hearing aids or eyeglasses respectively; With a history of epilepsy/seizures in the last six months and without the use of specific medication; Children who, even with the formal consent of those responsible for them, do not accept to participate in the research.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exergaming Group (EG)<br>The EG will participate in the intervention protocol with exergaming and will also receive the guidance booklet at the end of the treatment. Protocol: twice a week, with a total duration of 40-45 minutes each, conducted by a single physiotherapist. The initial 10 minutes will be for reception, accommodation/heating and anticipation of the service. The Exergaming will last 25-30 minutes, observing the children's reactions to the dosage of the game and the manual and verbal interventions of the physiotherapist. The final 5 minutes will be for cooling down (relaxing music). The video game will be the Xbox 360 with a Kinect TM sensor , which captures body movement during the game. The game will be Kinect Adventures!, and minigames: peak of reflections and 20,000 leaks. During the game, the physiotherapist will stimulate the child's proprioception in order to promote sensory and verbal feedback. The intervention will last 12 weeks, with 2 weekly sessions, totaling 24 sessions. | Other: Exergaming<br>* Use of the exergame XboX 360 series with kinect sensor<br>|
| Active Comparator: Control Group (CG)<br>The CG will be formed by participants admitted to the institution and who are on the waiting list for physiotherapy care and will follow the guidelines of the physiotherapy booklet with recommendations for physical activities that encourage the child's usual mobility, such as: moments of play with the family, walks outdoors and encourage varied ludic motor experiences. This booklet will be created by the researcher and will not change the routine of the service. The CG will be telemonitored biweekly via messaging application by the researcher, through a personal telephone, with a proposal to check the progress of the application of the booklet, clarify doubts with the family and monitor the child. This telemonitoring protocol was established exclusively for the research. | Other: Booklet<br>* Use of the booklet with instructions of exercises to be done at home with tele-health through whatsapp app.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in performance of gait evaluated through gait analysis - stride length, cadence, velocity, distribution of standing support, size of the support base, oscillation of the center of balance during walking | Gait analysis in the tridimensional laboratory of gait | pre-intervention and immediately after the intervention | 
| Change in the risk of falls evaluated through Pediatric Balance Scale [description above] | Cutoff point for predicting falls is 36 points for children | pre-intervention and immediately after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of falls evaluated through a questionnaire about falls [description above] | Number and frequency of falls, when the child falls most frequently and the circumstance of the last fall | pre-intervention and immediately after the intervention | 
| Changes in postural balance evaluated through Pediatric Balance Scale [description above] | Maximum of 56 points, which means ability to perform all tasks | pre-intervention and immediately after the intervention | 
| Changes in coordination evaluated through DCDQ [description above] | For a 5 year-old-child: from 15 to 46 means problem in coordination; For a 8 year-old-child to 9 year-old-child: from 15 to 55 means problem in coordination | pre-intervention and immediately after the intervention | 
| Changes in the motivation about exercising evaluated through an adapted motivational scale for ASD [description above] | 0 means not motivated; 1-3 less motivation; 4-7 moderated motivation; 8-10 great motivation | pre-intervention and immediately after the intervention | 
| Level of Satisfaction through questionnaire [description above] | 0 means dissatisfaction; 1-3 less satisfaction; 4-7 moderated satisfaction; and 8-10 means great satisfaction | pre-intervention and immediately after the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AUTISM SPECTRUM DISORDER, GAIT, ACIDENTAL FALLS, EXERGAMING, PHYSICAL THERAPY MODALITIES