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

Primary Purpose

Autism Spectrum Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exergaming
Booklet
Sponsored by
Federal University of Bahia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring AUTISM SPECTRUM DISORDER, GAIT, ACIDENTAL FALLS, EXERGAMING, PHYSICAL THERAPY MODALITIES

Eligibility Criteria

5 Years - 9 Years (Child)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Exergaming Group (EG)

    Control Group (CG)

    Arm Description

    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.

    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.

    Outcomes

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

    Secondary Outcome Measures

    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
    Changes in postural balance evaluated through Pediatric Balance Scale [description above]
    Maximum of 56 points, which means ability to perform all tasks
    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
    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
    Level of Satisfaction through questionnaire [description above]
    0 means dissatisfaction; 1-3 less satisfaction; 4-7 moderated satisfaction; and 8-10 means great satisfaction

    Full Information

    First Posted
    May 29, 2023
    Last Updated
    June 9, 2023
    Sponsor
    Federal University of Bahia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05908357
    Brief Title
    Study of Two Exercises Protocols for Autism Spectrum Disorder
    Acronym
    STEP-TEA
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2023 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    March 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of Bahia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Autism Spectrum Disorder
    Keywords
    AUTISM SPECTRUM DISORDER, GAIT, ACIDENTAL FALLS, EXERGAMING, PHYSICAL THERAPY MODALITIES

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Masking Description
    Both assessors participating in the study will be masking for the group of the participant.
    Allocation
    Randomized
    Enrollment
    22 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Exergaming Group (EG)
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control Group (CG)
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Exergaming
    Intervention Description
    Use of the exergame XboX 360 series with kinect sensor
    Intervention Type
    Other
    Intervention Name(s)
    Booklet
    Intervention Description
    Use of the booklet with instructions of exercises to be done at home with tele-health through whatsapp app.
    Primary Outcome Measure Information:
    Title
    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
    Description
    Gait analysis in the tridimensional laboratory of gait
    Time Frame
    pre-intervention and immediately after the intervention
    Title
    Change in the risk of falls evaluated through Pediatric Balance Scale [description above]
    Description
    Cutoff point for predicting falls is 36 points for children
    Time Frame
    pre-intervention and immediately after the intervention
    Secondary Outcome Measure Information:
    Title
    Prevalence of falls evaluated through a questionnaire about falls [description above]
    Description
    Number and frequency of falls, when the child falls most frequently and the circumstance of the last fall
    Time Frame
    pre-intervention and immediately after the intervention
    Title
    Changes in postural balance evaluated through Pediatric Balance Scale [description above]
    Description
    Maximum of 56 points, which means ability to perform all tasks
    Time Frame
    pre-intervention and immediately after the intervention
    Title
    Changes in coordination evaluated through DCDQ [description above]
    Description
    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
    Time Frame
    pre-intervention and immediately after the intervention
    Title
    Changes in the motivation about exercising evaluated through an adapted motivational scale for ASD [description above]
    Description
    0 means not motivated; 1-3 less motivation; 4-7 moderated motivation; 8-10 great motivation
    Time Frame
    pre-intervention and immediately after the intervention
    Title
    Level of Satisfaction through questionnaire [description above]
    Description
    0 means dissatisfaction; 1-3 less satisfaction; 4-7 moderated satisfaction; and 8-10 means great satisfaction
    Time Frame
    pre-intervention and immediately after the intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    9 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Karen V Trippo, Dr
    Phone
    +5571993208681
    Email
    ktrippo@ufba.br
    First Name & Middle Initial & Last Name or Official Title & Degree
    Milena V Deitos, Msc Student
    Phone
    +5571993087430
    Email
    milenadeitos@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    22114543
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    28508177
    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.
    Results Reference
    background
    PubMed Identifier
    30332294
    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.
    Results Reference
    background
    PubMed Identifier
    16137297
    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.
    Results Reference
    background
    PubMed Identifier
    33370161
    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.
    Results Reference
    background
    PubMed Identifier
    22699691
    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.
    Results Reference
    background
    PubMed Identifier
    29226773
    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.
    Results Reference
    background
    PubMed Identifier
    33522583
    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.
    Results Reference
    background
    PubMed Identifier
    34387753
    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.
    Results Reference
    background
    Links:
    URL
    http://www.consort-statement.org
    Description
    CONSORT STATEMENT

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