Study of Two Exercises Protocols for Autism Spectrum Disorder

Autism Spectrum Disorder Clinical Trial

— STEP-TEA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05908357
• Other study ID #: 66594723.2.0000.5543
• Status: Recruiting
• Phase: N/A
• Start date: August 25, 2023
• Est. completion date: March 2025

Study information

• Verified date: February 2024
• Source: Federal University of Bahia
• Contact: Karen V Trippo, Dr
• Phone: +5571993208681
• Email: ktrippo[@]ufba.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: March 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 9 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Other:
• Exergaming
Use of the exergame XboX 360 series with kinect sensor
• Booklet
Use of the booklet with instructions of exercises to be done at home with tele-health through whatsapp app.

Locations

Country	Name	City	State
Brazil	Instituto Baiano de Reabilitação - Fundação José Silveira	Salvador	Bahia

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Bahia

Country where clinical trial is conducted

Brazil, 

References & Publications (9)

Anderson-Hanley C, Tureck K, Schneiderman RL. Autism and exergaming: effects on repetitive behaviors and cognition. Psychol Res Behav Manag. 2011;4:129-37. doi: 10.2147/PRBM.S24016. Epub 2011 Sep 16. — View Citation

Fang Q, Aiken CA, Fang C, Pan Z. Effects of Exergaming on Physical and Cognitive Functions in Individuals with Autism Spectrum Disorder: A Systematic Review. Games Health J. 2019 Apr;8(2):74-84. doi: 10.1089/g4h.2018.0032. Epub 2018 Oct 17. — View Citation

Lamb SE, Jorstad-Stein EC, Hauer K, Becker C; Prevention of Falls Network Europe and Outcomes Consensus Group. Development of a common outcome data set for fall injury prevention trials: the Prevention of Falls Network Europe consensus. J Am Geriatr Soc. 2005 Sep;53(9):1618-22. doi: 10.1111/j.1532-5415.2005.53455.x. — View Citation

Lim YH, Partridge K, Girdler S, Morris SL. Standing Postural Control in Individuals with Autism Spectrum Disorder: Systematic Review and Meta-analysis. J Autism Dev Disord. 2017 Jul;47(7):2238-2253. doi: 10.1007/s10803-017-3144-y. — View Citation

Rafiei Milajerdi H, Sheikh M, Najafabadi MG, Saghaei B, Naghdi N, Dewey D. The Effects of Physical Activity and Exergaming on Motor Skills and Executive Functions in Children with Autism Spectrum Disorder. Games Health J. 2021 Feb;10(1):33-42. doi: 10.1089/g4h.2019.0180. Epub 2020 Dec 23. — View Citation

Ries LG, Michaelsen SM, Soares PS, Monteiro VC, Allegretti KM. Cross-cultural adaptation and reliability analysis of the Brazilian version of Pediatric Balance Scale (PBS). Rev Bras Fisioter. 2012 Jun;16(3):205-15. doi: 10.1590/s1413-35552012005000026. Epub 2012 Jun 14. English, Portuguese. — View Citation

Toscano CVA, Carvalho HM, Ferreira JP. Exercise Effects for Children With Autism Spectrum Disorder: Metabolic Health, Autistic Traits, and Quality of Life. Percept Mot Skills. 2018 Feb;125(1):126-146. doi: 10.1177/0031512517743823. Epub 2017 Dec 9. — View Citation

Wu YT, Tsao CH, Huang HC, Yang TA, Li YJ. Relationship Between Motor Skills and Language Abilities in Children With Autism Spectrum Disorder. Phys Ther. 2021 May 4;101(5):pzab033. doi: 10.1093/ptj/pzab033. — View Citation

Zampella CJ, Wang LAL, Haley M, Hutchinson AG, de Marchena A. Motor Skill Differences in Autism Spectrum Disorder: a Clinically Focused Review. Curr Psychiatry Rep. 2021 Aug 13;23(10):64. doi: 10.1007/s11920-021-01280-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   CONSORT STATEMENT