Effects of a Multimodal Exercise Program for Children With ASD

Autism Spectrum Disorder Clinical Trial

Official title:

Effects of a Multimodal Exercise Program for Children With Autistic Spectrum Disorder (ASD) on Cognitive and Motor Abilities: Part III

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05509231
• Other study ID #: BHS-1599
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 12, 2024
• Est. completion date: January 31, 2024

Study information

• Verified date: November 2023
• Source: New York Institute of Technology
• Contact: Alexander Lopez, JD, OT/L
• Phone: 631-252-5776
• Email: alopez[@]nyit.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Exploring the effects of an exercise program for children ages 6 -26 years old who have been diagnosed with autism spectrum disorder and neurotypical children respond to high-intensity whole body exercise interventions (Group 1), training using a sensory glove and armband (Group 2), no-intervention control (waitlist control) (Group 3). Approximately 50 children and adolescents will volunteer to participate in this program with participants parents' (or legal guardians') permission. This study will be conducted at an off-site pediatric occupational therapy facility Inclusive Sports and Fitness, Inc. (ISF).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 27 Years

Eligibility

Inclusion Criteria:

1. Clinical diagnosis of Autism Spectrum Disorder (ASD)

• Level 1 or Level 2

2. Neuro-typical individual with no history of developmental disabilities

3. Medical clearance to participate in the physical fitness activities

Exclusion Criteria:

1. Diagnosis of Autism Spectrum Disorder (ASD)

• Level 3

2. Nonverbal

3. IQ below 80 as assessed by the Wechsler Abbreviated Scale of Intelligence

4. History of seizures or head trauma; and any medical condition that precludes participants from participating in physical fitness activities.

Related Conditions & MeSH terms

• Asperger Syndrome
• Autism Spectrum Disorder

Intervention

Behavioral:
• High-intensity exercise
Gross motor physical fitness activities to improve proprioceptive awareness, motor control, and coordination.

Device:
• Wearable glove and arm sleeve device to measure movement
Sign language and other fine motor skills activities using wearable technology.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
New York Institute of Technology

References & Publications (12)

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: 10.1080/2047386 — View Citation

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 site — View Citation

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, Const — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.ne — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Kinematic Assessment with Glove and Arm Band	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
Primary	Bruininks-Oseretsky Test of Motor Proficiency (BOT-2)	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	Qualitative EEG (qEEG)	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
Secondary	Wearable technology: Glove and armband	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