Study of Two Exercises Protocols for Autism Spectrum Disorder

NCT05908357 | Completed

• 1 other identifier: 66594723.2.0000.5543
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Keywords

AUTISM SPECTRUM DISORDER; GAIT; ACIDENTAL FALLS; EXERGAMING; PHYSICAL THERAPY MODALITIES

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Prevalence of falls evaluated through a questionnaire about falls [description above]

  pre-intervention and immediately after the intervention

• Changes in postural balance evaluated through Pediatric Balance Scale [description above]

  pre-intervention and immediately after the intervention

• Changes in coordination evaluated through DCDQ [description above]

  pre-intervention and immediately after the intervention

• Changes in the motivation about exercising evaluated through an adapted motivational scale for ASD [description above]

  pre-intervention and immediately after the intervention

• Level of Satisfaction through questionnaire [description above]

  pre-intervention and immediately after the intervention

Study Arms (2)

Exergaming Group (EG)

EXPERIMENTAL

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

Control Group (CG)

ACTIVE COMPARATOR

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

Interventions

Exergaming OTHER

Use of the exergame XboX 360 series with kinect sensor

Exergaming Group (EG)

Booklet OTHER

Use of the booklet with instructions of exercises to be done at home with tele-health through whatsapp app.

Control Group (CG)

Eligibility Criteria

• Age: 5 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Bahia: lead

Study Sites (1)

Instituto Baiano de Reabilitação - Fundação José Silveira

Salvador, Estado de Bahia, 40170-010, Brazil

Location

Related 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.

  PMID: 22114543 BACKGROUND

• 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.

  PMID: 28508177 BACKGROUND

• 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.

  PMID: 30332294 BACKGROUND

• 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.

  PMID: 16137297 BACKGROUND

• 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.

  PMID: 33370161 BACKGROUND

• 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.

  PMID: 22699691 BACKGROUND

• 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.

  PMID: 29226773 BACKGROUND

• 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.

  PMID: 33522583 BACKGROUND

• 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.

  PMID: 34387753 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Exergaming

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Milena V Deitos, Msc Student

  Federal University of Bahia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Both assessors participating in the study will be masking for the group of the participant.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 29, 2023
• First Posted: June 18, 2023
• Study Start: August 25, 2023
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)