Can structured physical activity be used to improve behavior, social interaction, communication skills, and sensory issues in children with Autism Spectrum Disorders?

1. Setting - The study will be conducted at Mathavam – the center for Neurodevelopmental Disorders, which caters to a significant number of children with autism spectrum disorders in the Northern Province of Sri Lanka.

2. a) Methods of Randomization- stratified randomization will be used to ensure that the control and treatment group are balanced for age. b) Unit of Randomization – individual child c) Methods of sequence generation – computer-generated 1:1 randomization schedule stratified by age and sex

3. Based on experiences working with children with autism, and a literature study, a ‘structured physical activity guide’ was formulated. This comprised of physical activities that help improve coordination, balance, muscle strength and joint strength of children. These include: Jogging (4 minutes), Tandem walking/walking on a line (5 minutes), single-leg standing (3 minutes), balance board activities (3 minutes), bar hanging activities (3 minutes), jumping on a trampoline (3 minutes), animal walks (4 minutes), swinging (3 minutes), sit to stand (2 minutes) and hydrotherapy (10 minutes). Along with the regular therapies provided at the center, the children in experimental group will be engaging in these physical activities for 40 minutes a day, thrice a week, for 3 months, at the center itself. Structured physical activity checklist consisting of the activities to be done and the dates on which the activities are done will be marked. Structured physical activities will be guided by an investigator of the study, who is a physiotherapist. Two other investigators of this study will involve in the pre and post outcome measures (CARS, ABLLS-R, sensory profile assessment and behavior check list). They are trained to administer these tools, and will be blinded about the grouping of the children.

4. Children in the control group will be engaged in unstructured physical activities for 40 minutes a day, thrice a week, for 3 months along with the regular therapies at the center. There is no guide for the unstructured physical activities. The therapist will facilitate the children to engage in whatever the physical activities the child wishes to do, and those they naturally do within the premises of the center. These include climbing on monkey pass, Hide and seek, seesaw, stair climbing etc The same investigator who conducts the intervention for the intervention group will facilitate unstructured physical activities in the children in the control group. This will help eliminate confound due to the presence of different therapists.

• Children diagnosed with Autism Spectrum Disorder (ASD)

• Age 3-8 years

• Both male and females

• Children with severe physical deformities which limit their motor movements, physical activities and independent play ability

• Children with co-existing neurological disorders ( cerebral palsy, learning disability, Downs syndrome, childhood epilepsy) will be excluded

• Children undergoing early intensive behavioral intervention (EIBI) therapy during the study period