Autism Spectrum DisorderSTEP-TEANCT05908357
Study of Two Exercises Protocols for Autism Spectrum Disorder
A study testing Exergaming and Booklet in people with Autism Spectrum Disorder, run by Federal University of Bahia at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 5 to 9 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Exergaming and Booklet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteBrazil
- Study dates
- 25 Aug 2023to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto Baiano de Reabilitação - Fundação José Silveira
Salvador, Estado de Bahia, 40170-010
About this study
Official title: Effects of Exergaming on Gait and Fall Risk in Children With Autism Spectrum Disorder (ASD): A Randomized Controlled Clinical Trial
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.
Read the detailed description
Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder with altered motor aspects, present among 50-88% of children with ASD1. They can present difficulties in motor planning, altered gait, postural imbalance, and decreasing postural control, thus increasing the risk of falls.
Children with ASD have variability in gait patterns intra-individually, considering stride length, stride time, and walking speed5. The gait kinematic alteration includes wider step width, decrease in gait velocity, increase in stance time, gait cycle and step time, and differences in cadence and gait cycle compared to children without ASD5. A study showed that children with ASD have a more severely impaired postural balance than other neurodevelopmental disorders and typical children.
The impaired gait patterns can lead to pain, fatigue, and joint stress, affecting the functional capacity of children with ASD and impacting their quality of life. Also, it has been suggested that the motor alterations present in children with ASD are related to difficulties in communication and socialization, difficulties in the development of cognitive abilities, contribute to adaptative dysfunction, decrease the physical functional capacity, and increase the chance of obesity. The motor abilities are strongly related to adaptative function and quality of life of children with ASD, anticipating the deficits in social communication.
Although there is evidence in the literature concerning motor difficulties in children with ASD, it is estimated that 1,34% of them are diagnosed with motor alteration. Besides, it is an underestimated diagnostic among physical therapists in clinical practice. This highlights the importance of functional diagnostics and the study of possible interventions that can be useful in clinical practice in treating motor alterations, especially gait, and the risk of falls.
Exergaming (EXG) has been used as a treatment in children with ASD, demonstrating positive results. Among the effects of EXG in children with ASD are an improvement in explosive strength, better performance in velocity and agility, improvement of aerobic capacity, better work memory capacity, better strength and agility, improved perception of competence, reduced stereotypical behaviors, improved measurement of executive function, reduced aimless arm movements, and decreased body mass index.
Thus, EXG is a valuable tool to treat children with ASD. However, few studies have used EXG to treat motor aspects, especially those related to gait or balance performance. This highlights the following question: Could EXG improve the gait and lessen the risk of falls in children with ASD? Therefore, the primary objective of this study is to describe a randomized and controlled clinical trial protocol to verify the effect of EXG on gait and risk of falls in children with ASD. The secondary objective is to describe the gait measurement and the risk of falls to assess the effect of exergaming in children with ASD. The hypothesis is that the EXG will lessen gait alterations in children with ASD and improve postural balance, lessening the risk of falls.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Exergaming, Booklet
- Keywords
- AUTISM SPECTRUM DISORDER, GAIT, ACIDENTAL FALLS, EXERGAMING, PHYSICAL THERAPY MODALITIES
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExergamingOther
Use of the exergame XboX 360 series with kinect sensor
BookletOther
Use of the booklet with instructions of exercises to be done at home with tele-health through whatsapp app.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: pre-intervention and immediately after the intervention
Secondary outcomes (5)
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
Measured: pre-intervention and immediately after the intervention
Changes in postural balance evaluated through Pediatric Balance Scale [description above]
Maximum of 56 points, which means ability to perform all tasks
Measured: pre-intervention and immediately after the intervention
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
Measured: pre-intervention and immediately after the intervention
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
Measured: pre-intervention and immediately after the intervention
Level of Satisfaction through questionnaire [description above]
0 means dissatisfaction; 1-3 less satisfaction; 4-7 moderated satisfaction; and 8-10 means great satisfaction
Measured: pre-intervention and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start25 Aug 2023
- Primary completion31 Dec 2024
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Bahia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KAREN VALADARES TRIPPO, Federal University of Bahia
- Investigators
- Milena V Deitos, Msc Student, Study chair, Federal University of Bahia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05908357
- Sponsor's protocol ID
- 66594723.2.0000.5543
- Acronym
- STEP-TEA
- Status last verified
- Apr 2025
- First submitted
- 29 May 2023
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22114543Lim 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.
PubMed 28508177Fang 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.
PubMed 30332294Lamb 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.
PubMed 16137297Rafiei 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.
PubMed 33370161Ries 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.
PubMed 22699691Toscano 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.
PubMed 29226773Wu 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.
PubMed 33522583Zampella 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.
PubMed 34387753
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exergaming on Gait and Fall Risk in Children With Autism Spectrum Disorder (ASD): A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05908357
- Acronym / sponsor ID
- STEP-TEA / 66594723.2.0000.5543
- Conditions
- Autism Spectrum Disorder
- Keywords
- AUTISM SPECTRUM DISORDER, GAIT, ACIDENTAL FALLS, EXERGAMING, PHYSICAL THERAPY MODALITIES
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Federal University of BahiaUniversity, hospital or other
- Study start
- 25 Aug 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder with altered motor aspects, present among 50-88% of children with ASD1. They can present difficulties in motor planning, altered gait, postural imbalance, and decreasing postural control, thus increasing the risk of falls.
Children with ASD have variability in gait patterns intra-individually, considering stride length, stride time, and walking speed5. The gait kinematic alteration includes wider step width, decrease in gait velocity, increase in stance time, gait cycle and step time, and differences in cadence and gait cycle compared to children without ASD5. A study showed that children with ASD have a more severely impaired postural balance than other neurodevelopmental disorders and typical children.
The impaired gait patterns can lead to pain, fatigue, and joint stress, affecting the functional capacity of children with ASD and impacting their quality of life. Also, it has been suggested that the motor alterations present in children with ASD are related to difficulties in communication and socialization, difficulties in the development of cognitive abilities, contribute to adaptative dysfunction, decrease the physical functional capacity, and increase the chance of obesity. The motor abilities are strongly related to adaptative function and quality of life of children with ASD, anticipating the deficits in social communication.
Although there is evidence in the literature concerning motor difficulties in children with ASD, it is estimated that 1,34% of them are diagnosed with motor alteration. Besides, it is an underestimated diagnostic among physical therapists in clinical practice. This highlights the importance of functional diagnostics and the study of possible interventions that can be useful in clinical practice in treating motor alterations, especially gait, and the risk of falls.
Exergaming (EXG) has been used as a treatment in children with ASD, demonstrating positive results. Among the effects of EXG in children with ASD are an improvement in explosive strength, better performance in velocity and agility, improvement of aerobic capacity, better work memory capacity, better strength and agility, improved perception of competence, reduced stereotypical behaviors, improved measurement of executive function, reduced aimless arm movements, and decreased body mass index.
Thus, EXG is a valuable tool to treat children with ASD. However, few studies have used EXG to treat motor aspects, especially those related to gait or balance performance. This highlights the following question: Could EXG improve the gait and lessen the risk of falls in children with ASD? Therefore, the primary objective of this study is to describe a randomized and controlled clinical trial protocol to verify the effect of EXG on gait and risk of falls in children with ASD. The secondary objective is to describe the gait measurement and the risk of falls to assess the effect of exergaming in children with ASD. The hypothesis is that the EXG will lessen gait alterations in children with ASD and improve postural balance, lessening the risk of falls.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exergaming Group (EG) | Experimental | Other: ExergamingThe 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. |
| Control Group (CG) | Active comparator | Other: BookletThe 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. |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExergamingUse of the exergame XboX 360 series with kinect sensor | Other | Exergaming Group (EG) |
| BookletUse of the booklet with instructions of exercises to be done at home with tele-health through whatsapp app. | Other | Control Group (CG) |
Primary outcome
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
Time frame: 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]
Time frame: pre-intervention and immediately after the intervention
Cutoff point for predicting falls is 36 points for children
5 secondary outcomes
Prevalence of falls evaluated through a questionnaire about falls [description above]
Time frame: pre-intervention and immediately after the intervention
Changes in postural balance evaluated through Pediatric Balance Scale [description above]
Time frame: pre-intervention and immediately after the intervention
Changes in coordination evaluated through DCDQ [description above]
Time frame: pre-intervention and immediately after the intervention
Changes in the motivation about exercising evaluated through an adapted motivational scale for ASD [description above]
Time frame: pre-intervention and immediately after the intervention
Level of Satisfaction through questionnaire [description above]
Time frame: pre-intervention and immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Background: PubMed 22114543Anderson-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.
- Background: PubMed 28508177Lim 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.
- Background: PubMed 30332294Fang 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.
- Background: PubMed 16137297Lamb 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.
- Background: PubMed 33370161Rafiei 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.
- Background: PubMed 22699691Ries 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.
- Background: PubMed 29226773Toscano 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.
- Background: PubMed 33522583Wu 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.
- Background: PubMed 34387753Zampella 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Milena V Deitos, Msc Student study chair
Federal University of Bahia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exergaming and Booklet in people with Autism Spectrum Disorder, run by Federal University of Bahia at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: pre-intervention and immediately after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05908357, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.