Effects of a Multimodal Exercise Program for Children With ASD

NCT05509231 | Unknown

• 1 other identifier: BHS-1599
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Autism Spectrum Disorder; Asperger Syndrome

Keywords

Developmental Coordination Disorder; Dyspraxia; Dysgraphia; Incoordination; Motor control

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Qualitative EEG (qEEG)

  10 minutes

• Wearable technology: Glove and armband

  Approximately 20-30 minutes

Other Outcomes (1)

• Kinematic Assessment with Glove and Arm Band

  Approximately 10-20 minutes

Study Arms (5)

ASD High-intensity Exercise (Group 1a - ASD)

EXPERIMENTAL

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.

Behavioral: High-intensity exercise

Neurotypical Group (Group 1b - Neurotpical)

EXPERIMENTAL

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.

Behavioral: High-intensity exercise

ASD Wearable Technology (Group 2a - ASD)

EXPERIMENTAL

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.

Device: Wearable glove and arm sleeve device to measure movement

ASD Wearable Technology (Group 2b - Neurotypical)

EXPERIMENTAL

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.

Device: Wearable glove and arm sleeve device to measure movement

Control (Group 3)

NO INTERVENTION

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.

Interventions

High-intensity exercise BEHAVIORAL

Gross motor physical fitness activities to improve proprioceptive awareness, motor control, and coordination.

Also known as: Gross motor physical fitness

ASD High-intensity Exercise (Group 1a - ASD); Neurotypical Group (Group 1b - Neurotpical)

Wearable glove and arm sleeve device to measure movement DEVICE

Sign language and other fine motor skills activities using wearable technology.

ASD Wearable Technology (Group 2a - ASD); ASD Wearable Technology (Group 2b - Neurotypical)

Eligibility Criteria

• Age: 6 Years - 27 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• New York Institute of Technology: lead

Related Publications (12)

• 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.

  PMID: 19440131 BACKGROUND

• 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.

  PMID: 22628458 BACKGROUND

• 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.

  PMID: 12798990 BACKGROUND

• 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.

  PMID: 2299115 BACKGROUND

• 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.

  PMID: 29701730 RESULT

• 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.

  PMID: 25317160 RESULT

• 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.

  PMID: 35937176 RESULT

• 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.

  PMID: 19901244 RESULT

• 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.

  PMID: 21467306 RESULT

• 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.

  PMID: 22456193 RESULT

• 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.

  PMID: 17326118 RESULT

• 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.

  PMID: 20006719 RESULT

MeSH Terms

Conditions

Autism Spectrum Disorder; Asperger Syndrome; Motor Skills Disorders; Apraxias; Agraphia; Ataxia

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Psychomotor Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Language Disorders; Communication Disorders; Specific Learning Disorder; Learning Disabilities; Dyskinesias

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Alexander Lopez, JD, OT/L

CONTACT

631-252-5776; alopez@nyit.edu

Maryam Ravan, Ph.D.

CONTACT

646-273-6178; mravan@nyit.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will consist of individuals diagnosed with autism spectrum disorder and neurotypical children. The intervention includes high-intensity whole-body exercise (Group 1), intervention using wearable technology (arm and sleeve sensor) (Group 2), and no-intervention control (waitlist control) (Group 3). Experienmental Group 1 will participate in a traditional physical fitness program combined with exergaming, Group 2 will train using wearable technology, and Group 3 will be waitlisted for the intervention.

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: August 22, 2022
• Study Start: January 12, 2024
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share