Clinical trial NCT06943274: SWOC Activities on Balance, Gait and Endurance in Children With Autism Spectrum Disorder
Official title: Effects of Standardized Walking Obstacle Course (SWOC) Activities on Balance, Gait and Endurance in Children With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Autism Spectrum Disorder
Balance
Standardized Obstacle Course
Pediatric balance scale
6-minute walk test
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2025-04-24
Enrollment: 44
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled trial performed, in which 44 children with age of 8-12 years will be taken randomly after meeting inclusion criteria. Children will be divided into two groups. Group A will receive a standard walking obstacle course (e.g balance beam, stepping stones, hurdles, soft mats, gait and endurance activities) 2-3 times a week. Group B will receive other form of physical activities such as standard physical activities (e.g walking, running, climbing, jumping) 2-3 times a week. Pre values were taken at 1st week and post values of intervention will be taken after 4th week of intervention to measure the effects of both therapies.
Primary purpose: OTHER

Brief summary: Autism Spectrum Disorder (ASD) is a developmental disorder characterized by challenges in social communication, social interaction, repetitive behaviors, and restrictive interests.

Affecting 0.2-2% of children, ASD often includes motor growth retardation, which worsens over time. The disorder is more commonly diagnosed in boys, and its cause is believed to be genetic, with environmental stimuli potentially activating certain genes. This study aims to explore the effects of Standardized Walking Obstacle Course (SWOC) activities on balance, gait, and endurance in children with ASD, seeking to discover novel treatment techniques that could enhance clinical practices and improve motor skills in these children.

This randomized controlled trial will be conducted over 10 months, with data collected from the Lahore Autism Center and PSRD hospital in Lahore, Punjab. The sample will include 44 children with confirmed ASD, aged 8 to 12 years, divided into two groups: one undergoing SWOC activities and the other receiving conventional physiotherapy. Interventions will occur 4 days a week for 30-40 minutes each day. Pre- and post-treatment measurements will be taken using the Pediatric Balance Scale (PBS), the 6-Minute Walk Test (6MWT), and Functional Gait Assessment (FGA).

Data will be analyzed using SPSS version 24, with statistical significance set at P = 0.05.

Detailed description: 4 weeks treatment plan.

Group A: A randomized controlled trial investigate the effect of a standard walking obstacle course activities on balance, gait and endurance in children with ASD. Activity could include navigating obstacles of varying height and width balancing on beam, stepping over hurdles and walking on different surfaces. 2-3 times for 4 weeks. Balance beam Stepping stones Hurdle Markers Soft Mats Balance activities Gait and Endurance activities

Group B: Either receive no interventions or engages in a different form of physical activities that doesn't focus on balance gait and endurance e.g standard physical education activities like walking, running climbing, jumping along with applied behavioral therapy, speech therapy and customized physical therapy. 2-3 times for 4 weeks.

Eligibility criteria: Inclusion Criteria:

* Children with confirmed diagnosis of ASD.
* Age of patients 8 to 12 year.
* Both male and female.
* Fall less than 15 times in 30 seconds in Flamingo balance scale test.

Exclusion Criteria:

* Severe physical impairment.
* Severe intellectual impairment.
* Comorbid conditions that could prevent participation.

Primary outcomes:
measure: Pediatric Berg's balance scale for balance assessment
timeFrame: Baseline, 4th week
measure: 6-minute walk test
timeFrame: Baseline, 4th week
measure: Gait outcome assessment list
timeFrame: Baseline, 4th week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Rising Sun Institute
state: Punjab
Study officials:
affiliation: Riphah International University
name: Kainat Subtain, MS-PPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Biffi E, Costantini C, Ceccarelli SB, Cesareo A, Marzocchi GM, Nobile M, Molteni M, Crippa A. Gait Pattern and Motor Performance During Discrete Gait Perturbation in Children With Autism Spectrum Disorders. Front Psychol. 2018 Dec 11;9:2530. doi: 10.3389/fpsyg.2018.02530. eCollection 2018.
citation: Rhiel S, Klay A, Keller U, van Hedel HJA, Ammann-Reiffer C. Comparing Walking-Related Everyday Life Tasks of Children with Gait Disorders in a Virtual Reality Setup With a Physical Setup: Cross-Sectional Noninferiority Study. JMIR Serious Games. 2024 Mar 18;12:e49550. doi: 10.2196/49550.