- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05509231
Effects of a Multimodal Exercise Program for Children With ASD
Effects of a Multimodal Exercise Program for Children With Autistic Spectrum Disorder (ASD) on Cognitive and Motor Abilities: Part III
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to explore the effects of a structured high-intensity sensorimotor exercise program on performance skills (cognitive or executive function and functional motor skills) and hand function of children diagnosed with autistic spectrum disorder (ASD) and a neurotypical group and an additional qEEG which will be administered during the 6-12 week period. The investigators would like to recruit 50 participants for this study.
The research design consists of a nonequivalent quasi-experimental multi-group (ASD and Neurotypical) pre and post-test group design: Experimental Group 1 (high-intensity whole-body exercise): Pretest - intervention - Post-test; Experimental Group 2 (Sensory glove and armband): Pretest-Intervention-Post-test. The pretest will consist of motor and cognitive testing and a quantitative electroencephalogram (qEEG). The administration of these measures will be conducted on the grounds of the clinical site (ISF). The same measures used at the pretest will be utilized during post-test.
The potential benefits from the findings of this study will provide important information as to the efficacy of using multimodal (multisensory) training with exergaming applications on performance skills and abilities. The multisensory feedback will come from a number of sensory-based activities and gaming mechanisms employed in occupational and physical therapy. To our knowledge, there is a limited number of studies in peer-reviewed literature using validated and reliable outcome assessments under scientifically rigorous methods. The children participating in this study will receive the benefits of being in a skill-oriented exercise and functional skills training program that will address their performance skills impairments. These types of programs are not available to this population, particularly for families with limited financial support. Cognitive interventions will address the participants' ability to process various sensory (visual, auditory, haptic, proprioceptive, and vestibular information. The intervention will include a combination of cognitive tasks and sensorimotor activities. The investigators are utilizing a dynamic system approach that integrates sensory, physical, and cognitive processes with wearable technology and gaming. This approach recognizes the plastic nature of the brain and its ability to adapt through skilled interventions. Recent studies have posited that the neural substructures associated with functional impairments in children with ASD are not localized to morphological brain disorders, but rather a connectome issue associated with interneuron network impairments. Disordered connectivity can impair information processing, integration, and application of information from the different "processing nodes" within a functional network. Children with ASD demonstrate poor integration of multisensory information utilizing qEEG. The researchers suggested that interventions that provide multisensory stimuli may help improve neural connections and help them develop strategies for functioning in mainstream environments. In addition to the multisensory interventions to advance interconnectivity in the brain, children will participate in high-intensity physical activity. High-intensity activity has been found to produce neurophysiological and morphological changes in the brain with subsequent cognitive improvements.
Test and measures will be administered using the Bruininks-Oseretsky Test of Motor Proficiency (BOT-2). The BOT-2 covers the age range of 4 to 21 years, with a 53-item assessment consisting of eight subtests designed as game-like tasks that measure hand and arm coordination, balance, mobility, and strength. Investigators will be including an assessment that will allow us to measure the quality of movement of the hand. It will also provide feedback to the user to better calibrate and isolate hand movements. The participant will don a glove and arm sleeve with inductive sensors that will measure hand performance. The participants are asked to make a series of hand gestures for numbers 1 to 9 based on the American Sign Language and then follow some patterns of arm movements. The glove will record the kinematic data corresponding to each hand gesture and arm movement using a set of inductive sensors in the form of patches to be attached to the arm, a glove, and/or a pad of inductive sensors. The data will be used to develop machine learning algorithms from the gestures and arm movements made by neurotypical and ASD children and young adults. Machine learning applications will provide user feedback to identify correct hand positions and improve fine motor capabilities.
Cognitive Performance Measure The Test of Variables of Attention (TOVA). The TOVA is a culture- and language-free, sufficiently long computerized test that requires no left/right discrimination or sequencing. Responses to visual or auditory stimuli are recorded with a unique, highly accurate (±1 ms) microswitch. The TOVA calculates response time variability (consistency), the response time (speed), commissions (impulsivity), and omissions (focus and vigilance). These calculations are then compared to a large age- and gender-matched normative sample, as well as to a sample population of individuals independently diagnosed with ADHD.
Qualitative EEG (qEEG) Those potential participants who meet the eligibility criteria of the screening visit will be invited to participate in the study. As a baseline, qEEG will be a measure and guide in the individualized intervention protocol group. The qEEG is used to study a person's brainwaves via an analytic procedure called "brain mapping." The qEEG is derived by digitally analyzing the EEG to measure the amount of various EEG frequencies at different scalp locations (power analysis) and the connections between different areas (coherence analysis). Quantitative EEG frequencies will be measured at 19 sites on the head. The data obtained at 19 standard sites on the head is compared with data from normal individuals in the Applied Neuroscience, Inc. database. qEEG data will be analyzed to obtain brain maps and Z Scores for each participant. These qEEG analyses will provide a baseline for before/during/after intervention comparison in the individualized intervention group.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Alexander Lopez, JD, OT/L
- Phone Number: 631-252-5776
- Email: alopez@nyit.edu
Study Contact Backup
- Name: Maryam Ravan, Ph.D.
- Phone Number: 646-273-6178
- Email: mravan@nyit.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Clinical diagnosis of Autism Spectrum Disorder (ASD)
- Level 1 or Level 2
- Neuro-typical individual with no history of developmental disabilities
- Medical clearance to participate in the physical fitness activities
Exclusion Criteria:
Diagnosis of Autism Spectrum Disorder (ASD)
- Level 3
- Nonverbal
- IQ below 80 as assessed by the Wechsler Abbreviated Scale of Intelligence
- History of seizures or head trauma; and any medical condition that precludes participants from participating in physical fitness activities.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: ASD High-intensity Exercise (Group 1a - ASD)
The high-intensity group (Group 1a - ASD).
Subjects will be asked to meet 2-3 times a week for exercise training for 60-90 minutes a session.
Subjects will be asked to take part in tests that measure motor skills and thinking abilities.
|
Gross motor physical fitness activities to improve proprioceptive awareness, motor control, and coordination.
Other Names:
|
EXPERIMENTAL: Neurotypical Group (Group 1b - Neurotpical)
The high-intensity group (Group 1b - Neurotypical).
Subjects will be asked to meet 2-3 times a week for exercise training for 60-90 minutes a session.
Subjects will be asked to take part in tests that measure motor skills and thinking abilities.
|
Gross motor physical fitness activities to improve proprioceptive awareness, motor control, and coordination.
Other Names:
|
EXPERIMENTAL: ASD Wearable Technology (Group 2a - ASD)
ASD Wearable Technology (Group 2a- ASD).
Subjects wear a glove and arm sleeve with sensors that will measure arm and hand performance.
Subjects will be training 2 times a week for 20-30 minutes.
The Subjects will be asked to copy a series of hand and arm gestures.
Subjects will perform a series of hand exercises with the glove.
The glove will record the movement data that will provide the investigators and subjects feedback on hand performance and fine motor capabilities.
|
Sign language and other fine motor skills activities using wearable technology.
|
EXPERIMENTAL: ASD Wearable Technology (Group 2b - Neurotypical)
ASD Wearable Technology (Group 2b - Neurotypical).
Subjects wear a glove and arm sleeve with sensors that will measure arm and hand performance.
Subjects will be training 2 times a week for 20-30 minutes.
The Subjects will be asked to copy a series of hand and arm gestures.
Subjects will perform a series of hand exercises with the glove.
The glove will record the movement data that will provide the investigators and subjects feedback on hand performance and fine motor capabilities.
|
Sign language and other fine motor skills activities using wearable technology.
|
NO_INTERVENTION: Control (Group 3)
The wait-list control group will not receive the experimental intervention but will be put on a waiting list to receive the intervention after the active intervention group completes the study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bruininks-Oseretsky Test of Motor Proficiency (BOT-2)
Time Frame: 60 minutes
|
Bruininks-Oseretsky Test of Motor Proficiency (BOT-2).
The BOT-2 covers the age range of 4 to 21 years, with a 53-item assessment consisting of eight subtests designed as game-like tasks that measure hand and arm coordination, balance, mobility, and strength.
|
60 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Qualitative EEG (qEEG)
Time Frame: 10 minutes
|
As a baseline, qEEG will be a measure and guide in the individualized intervention protocol group.
The qEEG is used to study a person's brainwaves via an analytic procedure called "brain mapping."
The qEEG is derived by digitally analyzing the EEG to measure the amount of various EEG frequencies at different scalp locations (power analysis) and the connections between different areas (coherence analysis).
Quantitative EEG frequencies will be measured at 19 sites on the head.
The data obtained at 19 standard sites on the head is compared with data from normal individuals in the Applied Neuroscience, Inc. database.
qEEG data will be analyzed to obtain brain maps and Z scores for each participant.
These qEEG analyses will provide a baseline for before/during/after intervention comparison in the individualized intervention group.
Furthermore, data obtained through qEEG before and after interventions will be used to evaluate the progress and modulation of brain functional connectivity.
|
10 minutes
|
Wearable technology: Glove and armband
Time Frame: Approximately 20-30 minutes
|
The assessment requires the donning of a glove and armband with inductive sensors that will measure hand performance.
The participants are asked to make a series of hand gestures for numbers 1 to 9 based on the American Sign Language and then follow some patterns of arm movements.
The glove will record the kinematic data corresponding to each hand gesture and arm movement using a set of inductive sensors in the form of patches to be attached to the arm, a glove, and/or a pad of inductive sensors.
|
Approximately 20-30 minutes
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Kinematic Assessment with Glove and Arm Band
Time Frame: Approximately 10-20 minutes
|
We will be including an assessment that will allow us to measure the quality of movement of the hand.
It will also provide feedback to the user to better calibrate and isolate hand movements.
The subjects will don a glove and arm sleeve with inductive sensors that will measure hand performance.
The subjects are asked to make a series of hand gestures for numbers 1 to 9 based on the American Sign Language and then follow some patterns of arm movements.
The glove will record the kinematic data corresponding to each hand gesture and arm movement using a set of inductive sensors in the form of patches to be attached to the arm, a glove, and/or a pad of inductive sensors.
The data will be used to develop machine learning algorithms from the gestures and arm movements made by neurotypical and ASD children and young adults.
Machine learning applications will provide user feedback to identify correct hand positions and improve fine motor capabilities.
|
Approximately 10-20 minutes
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- David FJ, Baranek GT, Giuliani CA, Mercer VS, Poe MD, Thorpe DE. A pilot study: coordination of precision grip in children and adolescents with high functioning autism. Pediatr Phys Ther. 2009 Summer;21(2):205-11. doi: 10.1097/PEP.0b013e3181a3afc2.
- Brandwein AB, Foxe JJ, Butler JS, Russo NN, Altschuler TS, Gomes H, Molholm S. The development of multisensory integration in high-functioning autism: high-density electrical mapping and psychophysical measures reveal impairments in the processing of audiovisual inputs. Cereb Cortex. 2013 Jun;23(6):1329-41. doi: 10.1093/cercor/bhs109. Epub 2012 May 24.
- Hillman CH, Snook EM, Jerome GJ. Acute cardiovascular exercise and executive control function. Int J Psychophysiol. 2003 Jun;48(3):307-14. doi: 10.1016/s0167-8760(03)00080-1.
- Rogers RL, Meyer JS, Mortel KF. After reaching retirement age physical activity sustains cerebral perfusion and cognition. J Am Geriatr Soc. 1990 Feb;38(2):123-8. doi: 10.1111/j.1532-5415.1990.tb03472.x.
- Baio J, Wiggins L, Christensen DL, Maenner MJ, Daniels J, Warren Z, Kurzius-Spencer M, Zahorodny W, Robinson Rosenberg C, White T, Durkin MS, Imm P, Nikolaou L, Yeargin-Allsopp M, Lee LC, Harrington R, Lopez M, Fitzgerald RT, Hewitt A, Pettygrove S, Constantino JN, Vehorn A, Shenouda J, Hall-Lande J, Van Naarden Braun K, Dowling NF. Prevalence of Autism Spectrum Disorder Among Children Aged 8 Years - Autism and Developmental Disabilities Monitoring Network, 11 Sites, United States, 2014. MMWR Surveill Summ. 2018 Apr 27;67(6):1-23. doi: 10.15585/mmwr.ss6706a1. Erratum In: MMWR Morb Mortal Wkly Rep. 2018 May 18;67(19):564. MMWR Morb Mortal Wkly Rep. 2018 Nov 16;67(45):1280.
- Liu H, Song L, Zhang T. Changes in brain activation in stroke patients after mental practice and physical exercise: a functional MRI study. Neural Regen Res. 2014 Aug 1;9(15):1474-84. doi: 10.4103/1673-5374.139465.
- Arslan E, Ince G, Akyuz M. Effects of a 12-week structured circuit exercise program on physical fitness levels of children with autism spectrum condition and typically developing children. Int J Dev Disabil. 2020 Sep 17;68(4):500-510. doi: 10.1080/20473869.2020.1819943. eCollection 2022.
- Fuentes CT, Mostofsky SH, Bastian AJ. Children with autism show specific handwriting impairments. Neurology. 2009 Nov 10;73(19):1532-7. doi: 10.1212/WNL.0b013e3181c0d48c.
- Mostofsky SH, Ewen JB. Altered connectivity and action model formation in autism is autism. Neuroscientist. 2011 Aug;17(4):437-48. doi: 10.1177/1073858410392381. Epub 2011 Apr 5.
- Autism and Developmental Disabilities Monitoring Network Surveillance Year 2008 Principal Investigators; Centers for Disease Control and Prevention. Prevalence of autism spectrum disorders--Autism and Developmental Disabilities Monitoring Network, 14 sites, United States, 2008. MMWR Surveill Summ. 2012 Mar 30;61(3):1-19.
- Muller RA. The study of autism as a distributed disorder. Ment Retard Dev Disabil Res Rev. 2007;13(1):85-95. doi: 10.1002/mrdd.20141. Erratum In: Ment Retard Dev Disabil Res Rev. 2007;13(2):195.
- Yanagisawa H, Dan I, Tsuzuki D, Kato M, Okamoto M, Kyutoku Y, Soya H. Acute moderate exercise elicits increased dorsolateral prefrontal activation and improves cognitive performance with Stroop test. Neuroimage. 2010 May 1;50(4):1702-10. doi: 10.1016/j.neuroimage.2009.12.023. Epub 2009 Dec 16.
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BHS-1599
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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