NCT06893718

Treadmill Training With and Without Compression Stockings on Toe Walking and Balance in Children With Autism.

Effects of Treadmill Training With and Without Compression Stockings on Toe Walking and Balance in Children With Autism.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Riphah International University · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

Autism Spectrum Disorder (ASD) affects around 1.7% of US children, with co-occurring conditions like ADHD, anxiety, and epilepsy complicating daily functioning. Early intervention strategies, such as sensory-based therapies and physical exercises like treadmill training, are used to improve motor skills and overall functioning in children with ASD. A randomized controlled trial is being conducted to evaluate the impact of treadmill interventions on children with toe-walking behaviors. Participants will be assigned to either Group A or Group B, with treadmill sessions with or without compression stockings. The study aims to investigate the potential benefits of treadmill therapy as part of a multidisciplinary approach to treating ASD.

Detailed description

Autism spectrum disorder (ASD) is a complex neurodevelopmental condition characterized by difficulties in social communication, repetitive behaviors, and sensory sensitivities, typically appearing early in life. The disorder's prevalence varies globally, with recent estimates in the US showing approximately 1.7% of children affected. Diagnosis relies on comprehensive evaluations using standardized tools, such as the Autism Diagnostic Observation Schedule, to assess behavioral patterns and developmental history. Individuals with ASD often experience cooccurring conditions like ADHD, anxiety, and epilepsy, which can further impact daily functioning. Motor abnormalities, including toe-walking, are observed in some cases and may indicate underlying neurological issues or developmental delays. Early intervention, including sensory-based therapies and physical exercises like treadmill training, aims to improve motor skills and overall functioning in children with ASD, highlighting the importance of multidisciplinary support for optimal developmental outcomes. The study will be a Randomized Controlled Trial (RCT) designed to investigate the impact of treadmill interventions on children with autism spectrum disorder (ASD) who exhibit toe-walking behaviors. Legal guardians will receive comprehensive information about the research objectives, methods, and potential benefits, and informed consent will be obtained prior to participation. Initial assessments will thoroughly evaluate each participant's baseline strength, frequency of toe walking, and balance using standardized tools like the 50-foot walk test for toe walking and the Pediatric Balance Scale for balance assessment. Participants meeting specific inclusion criteria: children diagnosed with ASD, displaying toe walking more than 30% of the time, and compliant with the treatment protocol and Exclusion Criteria: Associated orthopedic conditions, underlying genetic disorders, global developmental delay, patient's parents'/guardians' refusal to provide informed consent will be assigned to either Group A or Group B by Non- Probability Convenient Sampling technique. Group A will undergo treadmill sessions while wearing compression stockings for one hour before and during a 10-minute treadmill walk, with incline adjustments from 10% to 12% over six weeks. Group B will undergo identical treadmill sessions without compression stockings. The study will be conducted in a controlled environment at a single autism center, ensuring consistent conditions for both groups. IBM SPSS Statistics version 27 will be used for data analysis.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
OTHER	Compressions Stocking Group	* Incline: Initially 5% incline and after 4 weeks an incline of 10% will be observed * Speed: Constant speed of 3.4 mph. * Warm up: Calf stretch 10 reps/ 2 sets.
OTHER	Treadmill Training Group	* Incline: Initially 5% incline and after 4 weeks an incline of 10% will be observed * Speed: Constant speed of 3.4 mph. * Warm up: Calf stretch 10 reps/ 2 sets.

Timeline

• Start date: 2025-03-15
• Primary completion: 2025-04-28
• Completion: 2025-05-12
• First posted: 2025-03-25
• Last updated: 2025-03-25

Locations

1 site across 1 country: Pakistan