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

Sponsor

Federal University of Bahia (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05908357

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Autism Spectrum Disorder	Other: Exergaming Other: Booklet	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

Both assessors participating in the study will be masking for the group of the participant.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Mar 1, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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 [pre-intervention and immediately after the intervention]
Gait analysis in the tridimensional laboratory of gait
Change in the risk of falls evaluated through Pediatric Balance Scale [description above] [pre-intervention and immediately after the intervention]
Cutoff point for predicting falls is 36 points for children

Secondary Outcome Measures

Prevalence of falls evaluated through a questionnaire about falls [description above] [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
Changes in postural balance evaluated through Pediatric Balance Scale [description above] [pre-intervention and immediately after the intervention]
Maximum of 56 points, which means ability to perform all tasks
Changes in coordination evaluated through DCDQ [description above] [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
Changes in the motivation about exercising evaluated through an adapted motivational scale for ASD [description above] [pre-intervention and immediately after the intervention]
0 means not motivated; 1-3 less motivation; 4-7 moderated motivation; 8-10 great motivation
Level of Satisfaction through questionnaire [description above] [pre-intervention and immediately after the intervention]
0 means dissatisfaction; 1-3 less satisfaction; 4-7 moderated satisfaction; and 8-10 means great satisfaction

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 9 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.