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The goal of this clinical trial is to assess the effect of short-term (3 days/week for 2 weeks) Virtual Reality (VR) active video gaming intervention on static and dynamic balance, versus traditional balance training exercises, in youth with ASD.
The participants in the intervention group will engage in VR active video gaming using the Nintendo Switch Sports under supervision via Zoom for 6 sessions occurring over 2 weeks, from their home. While, the participants in the control group will engage in standard physical therapy exercises for balance and walking under supervision via Zoom, for 6 sessions occurring over 2 weeks, from their home.
Their balance and walking will be assessed 3 times, 3-5 days before the intervention, 3-5 days after the intervention and 4-weeks after the intervention.
The difference in the balance and walking parameters will be assessed and compared.
Postural control deficits, also referred to as balance deficits, are a noted example of impaired motor-skills and are increasingly considered as one of the primary markers for autism spectrum disorder (ASD)1-5. However, there are very few controlled clinical trials examining effects of balance interventions in individuals with ASD. Moreover, to date there exist few effective interventions based on well-designed research that address balance deficits in youth with ASD and are home-implemented, cost-effective, generalizable, and enjoyable and that promote adherence. Virtual reality (VR) active gaming is one such intervention that incorporates scientific mechanisms for improving balance. But, there exist few, evidence-based best practices that use this method to address balance in youth with ASD. In addition to being based on principles of motor learning/control, commercially available VR active gaming can be affordable, enjoyable, at-home intervention. Thus, the aim of this study is to assess the effect of short-term (3 days/week for 2 weeks) Virtual Reality (VR) active video gaming intervention on static and dynamic balance, versus traditional balance training exercises, in youth with ASD.
This study will take place at the Physical Activity and Biomechanics Labs at School of Public Health, Indiana University, Bloomington, and participants home for total of 9 sessions occurring over 7-8 weeks.
Before participants come to the lab:
Participants' parent/guardian will complete a couple of questionnaires that will ask questions about any medications that participant takes and about participants' physical health to make sure it is safe for the participant to participate in the study. They will also answer questions that are used to determine if someone might have ASD.
Participants will be shown a video which will give them information about the lab they will be coming to do some of the study activities, and information about the people that will be working with them during the study. Participants will then be randomly assigned (like flipping a coin) to one of two groups: the Virtual Reality Group, or the Exercise Group. This will determine what activities or exercise they will do for the upcoming sessions.
Session #1, about 90 minutes:
Researchers measure participants height, weight, and length of arm and leg. Researchers will also measure which hand participants prefer to perform daily activities using Edinburgh Handedness Inventory- short form (EHI-SF). Participants will also stand on a large mat containing sensors that will measure how much their body moves back and forth while they are standing. Participants will stand on the mat for 30 seconds with their eyes open, and then for 30 seconds with their eyes closed.
Then, researchers will measure how well participants are able to balance by having them do some activities like sitting and standing without help, standing with their eyes closed, reaching forward with their arms stretched in front, placing their right then left foot on a stool, standing with alternating foot in front, and standing on one foot, alternating right and left. The researcher will show the participants how to do each of these, and they can practice a couple of times before the test begins.
Participants will then do some walking in the lab with special sensors that are attached to their lower back and feet. This will measure how participants walk. The sensors are attached with special tape to the cloths and shoes, and are not painful. A special camera will take pictures as the participants walk, and video recording will be done as well. Participants will do this several times and will be reminded to walk at a normal pace.
Lastly, if the participants are in the Virtual Reality Group, their parent/guardian will receive the Nintendo switch™ console and the sports game to take home.
At home, 3 times a week for two weeks for 30-40 minutes (Sessions 2-7):
Sessions 8 and 9 (in the lab), about an hour:
Session #8: 3-5 days after session 7, Participants will complete all the balance and walking measurements that they did in session #1 excluding parameters such as EHI-SF, leg and arm length, weight, height. It will take approximately 1 hour.
On session #9: 4 weeks after session #7, participants will once again complete all the same activities they completed during visit #8. It will take approximately 1 hour.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual reality active video gaming | Experimental | The participants in this group will engage in VR active gaming using Nintendo Switch Sports under supervision via Zoom, for 6 sessions over 2 weeks. |
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| Standard balance exercises | Active Comparator | The participants in this group will engage in standard physical therapy exercises for balance and walking under supervision via Zoom, for 6 sessions over 2 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality active video gaming using Nintendo switch sports | Device | Playing 2 pre-selected VR active video games from beach tennis, soccer, volleyball, badminton, bowling, and chambara for 10 minutes each with a 5 minute break in-between. Total duration 30-40 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Center of Pressure Movement (Postural Sway Velocity) | High resolution pressure mat containing multiple integrated sensors is used to detect center of pressure movement of the person standing on it recorded at 100 Hz | 5 days before the intervention, 5 days after the intervention and 4 weeks after the intervention |
| Change in Pediatric Berg's Balance Scale Score | Pediatric Berg's balance Scale: 14-component battery that evaluates daily living tasks such as sitting to standing, transferring from one chair to another, and sitting and standing without support. This scale is reliable and valid clinical balance assessment tool for children and youth with motor impairments. Maximum total score is 56 points and minimum total score is 0 points. Higher score indicates better balance such that increase in total score by 3.7 points indicates minimal clinically important difference. | 5 days before the intervention, 5 days after the intervention, 4 weeks after the intervention |
| Change in Step Length (Meters) of the Gait | 13-infra red camera system with 19-light reflecting passive markers recording at 100 Hz are used to measure the gait parameter: step length (meters). | 5 days before the intervention, 5 days after the intervention, 4 weeks after the intervention |
| Change in Stride Width (Meters) of the Gait | 13-infra red camera system with 19-light reflecting passive markers recording at 100 Hz are used to measure the gait parameter: step width (meters). | 5 days before the intervention, 5 days after the intervention, 4 weeks after the intervention |
| Change in Stride Length (Meters) of the Gait | 13-infra red camera system with 19-light reflecting passive markers recording at 100 Hz are used to measure the gait parameter: stride length (meters). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Georgia Frey, Ph.D. | Indiana University, Bloomington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Bloomington | Bloomington | Indiana | 47405 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21478224 | Background | Nobile M, Perego P, Piccinini L, Mani E, Rossi A, Bellina M, Molteni M. Further evidence of complex motor dysfunction in drug naive children with autism using automatic motion analysis of gait. Autism. 2011 May;15(3):263-83. doi: 10.1177/1362361309356929. Epub 2011 Apr 8. | |
| 28508177 | 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. |
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Individual participant data will not be shared to maintain the confidentiality of the participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Virtual Reality Active Video Gaming | The participants in this group will engage in VR active gaming using Nintendo Switch Sports under supervision via Zoom, for 6 sessions over 2 weeks. Virtual reality active video gaming using Nintendo switch sports: Playing 2 pre-selected VR active video games from beach tennis, soccer, volleyball, badminton, bowling, and chambara for 10 minutes each with a 5 minute break in-between. Total duration 30-40 minutes. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 1, 2024 |
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Two groups, intervention and the control, will be compared within and between longitudinally 3 times. Before-, after- and 4 weeks after the intervention.
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| Standard physical therapy balance exercises | Behavioral | Balance exercises: Standing with feet together for 10 seconds 5 times, standing with 1 foot in front of other for 10 seconds 5 times on both sides, standing on one leg for 10 seconds 5 times on both sides, walking with one foot in front of other on a 1-meter-long line for 5 repetitions and standing on a balance board for 30 seconds for 3 repetitions. 5 minutes each of warm-up and cool down exercises. Total duration 20-30 minutes. |
|
| 5 days before the intervention, 5 days after the intervention, 4 weeks after the intervention |
| Change in Double Support Period (Seconds) of the Gait | 13-infra red camera system with 19-light reflecting passive markers recording at 100 Hz are used to measure the gait parameter: double support period (seconds). | 5 days before the intervention, 5 days after the intervention, 4 weeks after the intervention |
| Change in the Cadence (Steps/Minute) of the Gait | 13-infra red camera system with 19-light reflecting passive markers recording at 100 Hz are used to measure the gait parameter: cadence (number of steps/minute). | 5 days before the intervention, 5 days after the intervention, 4 weeks after the intervention |
| Change in Gait Velocity (Meters/Second) | 13-infra red camera system with 19-light reflecting passive markers recording at 100 Hz are used to measure the gait parameter: gait velocity (meters/second). | 5 days before the intervention, 5 days after the intervention, 4 weeks after the intervention |
| 28660313 | Background | Harris SR. Early motor delays as diagnostic clues in autism spectrum disorder. Eur J Pediatr. 2017 Sep;176(9):1259-1262. doi: 10.1007/s00431-017-2951-7. Epub 2017 Jun 28. |
| 34414860 | Background | Li Y, Liu T, Venuti CE. Development of postural stability in children with autism spectrum disorder: a cross-sectional study. Int Biomech. 2021 Dec;8(1):54-62. doi: 10.1080/23335432.2021.1968316. |
| 15596750 | Background | Minshew NJ, Sung K, Jones BL, Furman JM. Underdevelopment of the postural control system in autism. Neurology. 2004 Dec 14;63(11):2056-61. doi: 10.1212/01.wnl.0000145771.98657.62. |
| 22160370 | Background | Mazurek MO, Shattuck PT, Wagner M, Cooper BP. Prevalence and correlates of screen-based media use among youths with autism spectrum disorders. J Autism Dev Disord. 2012 Aug;42(8):1757-67. doi: 10.1007/s10803-011-1413-8. |
| 30205483 | Background | Ye S, Lee JE, Stodden DF, Gao Z. Impact of Exergaming on Children's Motor Skill Competence and Health-Related Fitness: A Quasi-Experimental Study. J Clin Med. 2018 Sep 7;7(9):261. doi: 10.3390/jcm7090261. |
| 21546566 | Background | Bhat AN, Landa RJ, Galloway JC. Current perspectives on motor functioning in infants, children, and adults with autism spectrum disorders. Phys Ther. 2011 Jul;91(7):1116-29. doi: 10.2522/ptj.20100294. Epub 2011 May 5. |
| 31782658 | Background | Ruggeri A, Dancel A, Johnson R, Sargent B. The effect of motor and physical activity intervention on motor outcomes of children with autism spectrum disorder: A systematic review. Autism. 2020 Apr;24(3):544-568. doi: 10.1177/1362361319885215. Epub 2019 Nov 29. |
| 34387753 | 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. |
| 24444657 | Background | Jelsma D, Geuze RH, Mombarg R, Smits-Engelsman BC. The impact of Wii Fit intervention on dynamic balance control in children with probable Developmental Coordination Disorder and balance problems. Hum Mov Sci. 2014 Feb;33:404-18. doi: 10.1016/j.humov.2013.12.007. Epub 2014 Jan 18. |
| 33370161 | 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. |
| 28921103 | Background | Travers BG, Mason AH, Mrotek LA, Ellertson A, Dean DC 3rd, Engel C, Gomez A, Dadalko OI, McLaughlin K. Biofeedback-Based, Videogame Balance Training in Autism. J Autism Dev Disord. 2018 Jan;48(1):163-175. doi: 10.1007/s10803-017-3310-2. |
| 32404919 | Background | Caldani S, Atzori P, Peyre H, Delorme R, Bucci MP. Short rehabilitation training program may improve postural control in children with autism spectrum disorders: preliminary evidences. Sci Rep. 2020 May 13;10(1):7917. doi: 10.1038/s41598-020-64922-4. |
| 17057441 | Background | Franjoine MR, Gunther JS, Taylor MJ. Pediatric balance scale: a modified version of the berg balance scale for the school-age child with mild to moderate motor impairment. Pediatr Phys Ther. 2003 Summer;15(2):114-28. doi: 10.1097/01.PEP.0000068117.48023.18. |
| 28714837 | Background | Goetschius J, Feger MA, Hertel J, Hart JM. Validating Center-of-Pressure Balance Measurements Using the MatScan(R) Pressure Mat. J Sport Rehabil. 2018 Jan 1;27(1). doi: 10.1123/jsr.2017-0152. Epub 2018 Jan 24. |
| 23291508 | Background | Chen CL, Shen IH, Chen CY, Wu CY, Liu WY, Chung CY. Validity, responsiveness, minimal detectable change, and minimal clinically important change of Pediatric Balance Scale in children with cerebral palsy. Res Dev Disabil. 2013 Mar;34(3):916-22. doi: 10.1016/j.ridd.2012.11.006. Epub 2013 Jan 3. |
| FG001 | Standard Balance Exercises | The participants in this group will engage in standard physical therapy exercises for balance and walking under supervision via Zoom, for 6 sessions over 2 weeks. Standard physical therapy balance exercises: Balance exercises: Standing with feet together for 10 seconds 5 times, standing with 1 foot in front of other for 10 seconds 5 times on both sides, standing on one leg for 10 seconds 5 times on both sides, walking with one foot in front of other on a 1-meter-long line for 5 repetitions and standing on a balance board for 30 seconds for 3 repetitions. 5 minutes each of warm-up and cool down exercises. Total duration 20-30 minutes. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Virtual Reality Active Video Gaming | The participants in this group will engage in VR active gaming using Nintendo Switch Sports under supervision via Zoom, for 6 sessions over 2 weeks. Virtual reality active video gaming using Nintendo switch sports: Playing 2 pre-selected VR active video games from beach tennis, soccer, volleyball, badminton, bowling, and chambara for 10 minutes each with a 5 minute break in-between. Total duration 30-40 minutes. |
| BG001 | Standard Balance Exercises | The participants in this group will engage in standard physical therapy exercises for balance and walking under supervision via Zoom, for 6 sessions over 2 weeks. Standard physical therapy balance exercises: Balance exercises: Standing with feet together for 10 seconds 5 times, standing with 1 foot in front of other for 10 seconds 5 times on both sides, standing on one leg for 10 seconds 5 times on both sides, walking with one foot in front of other on a 1-meter-long line for 5 repetitions and standing on a balance board for 30 seconds for 3 repetitions. 5 minutes each of warm-up and cool down exercises. Total duration 20-30 minutes. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change in the Center of Pressure Movement (Postural Sway Velocity) | High resolution pressure mat containing multiple integrated sensors is used to detect center of pressure movement of the person standing on it recorded at 100 Hz | Posted | Mean | Standard Deviation | cm/sec | 5 days before the intervention, 5 days after the intervention and 4 weeks after the intervention |
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| Primary | Change in Pediatric Berg's Balance Scale Score | Pediatric Berg's balance Scale: 14-component battery that evaluates daily living tasks such as sitting to standing, transferring from one chair to another, and sitting and standing without support. This scale is reliable and valid clinical balance assessment tool for children and youth with motor impairments. Maximum total score is 56 points and minimum total score is 0 points. Higher score indicates better balance such that increase in total score by 3.7 points indicates minimal clinically important difference. | Posted | Mean | Standard Deviation | score on a scale | 5 days before the intervention, 5 days after the intervention, 4 weeks after the intervention |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Change in Step Length (Meters) of the Gait | 13-infra red camera system with 19-light reflecting passive markers recording at 100 Hz are used to measure the gait parameter: step length (meters). | Posted | Mean | Standard Deviation | m | 5 days before the intervention, 5 days after the intervention, 4 weeks after the intervention |
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| Primary | Change in Stride Width (Meters) of the Gait | 13-infra red camera system with 19-light reflecting passive markers recording at 100 Hz are used to measure the gait parameter: step width (meters). | Posted | Mean | Standard Deviation | m | 5 days before the intervention, 5 days after the intervention, 4 weeks after the intervention |
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| Primary | Change in Stride Length (Meters) of the Gait | 13-infra red camera system with 19-light reflecting passive markers recording at 100 Hz are used to measure the gait parameter: stride length (meters). | Posted | Mean | Standard Deviation | m | 5 days before the intervention, 5 days after the intervention, 4 weeks after the intervention |
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| Primary | Change in Double Support Period (Seconds) of the Gait | 13-infra red camera system with 19-light reflecting passive markers recording at 100 Hz are used to measure the gait parameter: double support period (seconds). | Posted | Mean | Standard Deviation | sec | 5 days before the intervention, 5 days after the intervention, 4 weeks after the intervention |
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| Primary | Change in the Cadence (Steps/Minute) of the Gait | 13-infra red camera system with 19-light reflecting passive markers recording at 100 Hz are used to measure the gait parameter: cadence (number of steps/minute). | Posted | Mean | Standard Deviation | steps/min | 5 days before the intervention, 5 days after the intervention, 4 weeks after the intervention |
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| Primary | Change in Gait Velocity (Meters/Second) | 13-infra red camera system with 19-light reflecting passive markers recording at 100 Hz are used to measure the gait parameter: gait velocity (meters/second). | Posted | Mean | Standard Deviation | m/sec | 5 days before the intervention, 5 days after the intervention, 4 weeks after the intervention |
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From baseline through end of follow-up (up to 8 weeks)
The participants were not at a risk of acquiring/ experiencing adverse events or mortality risk as it is a behavioral intervention, comparing two methods of administrating physical therapy for improving static and dynamic balance in youth and young adults with ASD. Minimal fall risk was mitigated through presence of chair at a hands distance from participants to grab in destabilizing condition and presence of caregiver in the room for entirety of intervention sessions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Virtual Reality Active Video Gaming | The participants in this group will engage in VR active gaming using Nintendo Switch Sports under supervision via Zoom, for 6 sessions over 2 weeks. Virtual reality active video gaming using Nintendo switch sports: Playing 2 pre-selected VR active video games from beach tennis, soccer, volleyball, badminton, bowling, and chambara for 10 minutes each with a 5 minute break in-between. Total duration 30-40 minutes. | 0 | 7 | 0 | 7 | 0 | 7 |
| EG001 | Standard Balance Exercises | The participants in this group will engage in standard physical therapy exercises for balance and walking under supervision via Zoom, for 6 sessions over 2 weeks. Standard physical therapy balance exercises: Balance exercises: Standing with feet together for 10 seconds 5 times, standing with 1 foot in front of other for 10 seconds 5 times on both sides, standing on one leg for 10 seconds 5 times on both sides, walking with one foot in front of other on a 1-meter-long line for 5 repetitions and standing on a balance board for 30 seconds for 3 repetitions. 5 minutes each of warm-up and cool down exercises. Total duration 20-30 minutes. | 0 | 6 | 0 | 6 | 0 | 6 |
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Limitations:
Both interventions were carried out under video supervision, and this may have impacted motivation.
All balance data was collected in laboratory-based setting. Findings therefore may not be generalizable to postural balance mechanics during outdoor or free-living walking.
Gender-based differences were present in the sample as prevalence of ASD is 4:1 male to female ratio
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Georgia Frey, Faculty, Department of Kinesiology | Indiana University | (812) 855-1262 | gfrey@iu.edu |
| Jul 8, 2025 |
| Prot_SAP_ICF_001.pdf |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| Between 18 and 65 years |
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| >=65 years |
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| post-2 |
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