Ignite Creation Date:
2024-05-06 @ 7:07 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05908357
Status:
RECRUITING
Last Update Posted:
2024-02-22
First Post:
2023-05-29
Brief Title:
Study of Two Exercises Protocols for Autism Spectrum Disorder
Sponsor:
Federal University of Bahia
Organization:
Federal University of Bahia
Study Overview
Official Title:
Effects of Exergaming on Gait and Fall Risk in Children With Autism Spectrum Disorder ASD A Randomized Controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STEP-TEA
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 n11 and Control Group GC n11 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 005 Pearsons 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None