Study of Two Exercises Protocols for Autism Spectrum Disorder (STEP-TEA)

April 10, 2025 updated by: KAREN VALADARES TRIPPO, Federal University of Bahia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder with altered motor aspects, present among 50-88% of children with ASD1. They can present difficulties in motor planning, altered gait, postural imbalance, and decreasing postural control, thus increasing the risk of falls.

Children with ASD have variability in gait patterns intra-individually, considering stride length, stride time, and walking speed5. The gait kinematic alteration includes wider step width, decrease in gait velocity, increase in stance time, gait cycle and step time, and differences in cadence and gait cycle compared to children without ASD5. A study showed that children with ASD have a more severely impaired postural balance than other neurodevelopmental disorders and typical children.

The impaired gait patterns can lead to pain, fatigue, and joint stress, affecting the functional capacity of children with ASD and impacting their quality of life. Also, it has been suggested that the motor alterations present in children with ASD are related to difficulties in communication and socialization, difficulties in the development of cognitive abilities, contribute to adaptative dysfunction, decrease the physical functional capacity, and increase the chance of obesity. The motor abilities are strongly related to adaptative function and quality of life of children with ASD, anticipating the deficits in social communication.

Although there is evidence in the literature concerning motor difficulties in children with ASD, it is estimated that 1,34% of them are diagnosed with motor alteration. Besides, it is an underestimated diagnostic among physical therapists in clinical practice. This highlights the importance of functional diagnostics and the study of possible interventions that can be useful in clinical practice in treating motor alterations, especially gait, and the risk of falls.

Exergaming (EXG) has been used as a treatment in children with ASD, demonstrating positive results. Among the effects of EXG in children with ASD are an improvement in explosive strength, better performance in velocity and agility, improvement of aerobic capacity, better work memory capacity, better strength and agility, improved perception of competence, reduced stereotypical behaviors, improved measurement of executive function, reduced aimless arm movements, and decreased body mass index.

Thus, EXG is a valuable tool to treat children with ASD. However, few studies have used EXG to treat motor aspects, especially those related to gait or balance performance. This highlights the following question: Could EXG improve the gait and lessen the risk of falls in children with ASD? Therefore, the primary objective of this study is to describe a randomized and controlled clinical trial protocol to verify the effect of EXG on gait and risk of falls in children with ASD. The secondary objective is to describe the gait measurement and the risk of falls to assess the effect of exergaming in children with ASD. The hypothesis is that the EXG will lessen gait alterations in children with ASD and improve postural balance, lessening the risk of falls.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Bahia
      • Salvador, Bahia, Brazil, 40170-010
        • Instituto Baiano de Reabilitação - Fundação José Silveira

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exergaming Group (EG)

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
Use of the exergame XboX 360 series with kinect sensor
Active Comparator: Control Group (CG)
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
Use of the booklet with instructions of exercises to be done at home with tele-health through whatsapp app.

What is the study measuring?

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
Time Frame: pre-intervention and immediately after the intervention
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]
Time Frame: pre-intervention and immediately after the intervention
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]
Time Frame: pre-intervention and immediately after the intervention
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]
Time Frame: pre-intervention and immediately after the intervention
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]
Time Frame: pre-intervention and immediately after the intervention
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]
Time Frame: pre-intervention and immediately after the intervention
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]
Time Frame: pre-intervention and immediately after the intervention
0 means dissatisfaction; 1-3 less satisfaction; 4-7 moderated satisfaction; and 8-10 means great satisfaction
pre-intervention and immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Bahia

Investigators

  • Study Chair: Milena V Deitos, Msc Student, Federal University of Bahia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2023

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

March 31, 2025

Study Registration Dates

First Submitted

May 29, 2023

First Submitted That Met QC Criteria

June 9, 2023

First Posted (Actual)

June 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 13, 2025

Last Update Submitted That Met QC Criteria

April 10, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 66594723.2.0000.5543

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Autism Spectrum Disorder

Clinical Trials on Exergaming

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Albania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe