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NCT Number: NCT06893718

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

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.

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Muhammad Asif Javed

Lahore, Punjab Province, 54000, Pakistan

Location status: Recruiting

Location contact

Muhammad Asif Javed, MS-PT(Neuro)

CONTACT

[email protected]

923224209422

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children with ASD who toe walk.
  • Gait disorder more than 30% of the time.
  • Compliance with our treatment protocol.
  • Children whose guardians agreed on the study

Exclusion criteria

  • Associated orthopedic conditions.
  • Underlying genetic disorders.
  • Global developmental delay.
  • Patient's parents'/guardians' refusal to provide informed consent

Treatment and study plan

Compressions Stocking Group

Other
  • 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.

Treadmill Training Group

Other
  • 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.

Primary outcomes

  1. Pediatric Balance Scale

    Time frame: baseline, 3rd week, 6th week.

    The 14-item Pediatric Balance Scale (PBS) is a tool used to assess children's functional balance. The PBS was created by altering the Berg Balance Scale (BBS) to be used with children with cerebral palsy (CP) who have trouble responding to external stimuli and maintaining their posture. For kids with mild to severe motor impairments, the PBS has been further refined as a balancing assessment tool.

  2. Toe Walking

    Time frame: baseline, 3rd week, 6th week.

    Trials frequently use the 50-Foot Timed Walk (50FTW) as a gait assessment tool. Initially, exercise-based research was the main application of the 50FWT. Around 15.24 meters (50 feet) away, the participants walk a straight line at their typical walking pace. A fat, colored tape was used to measure a distance of 15.24 meters to chart the course.

Study contacts

Contact information is provided by the study sponsor or research team.

IMRAN AMJAD, PHD

CONTACT

[email protected]

9233224390125

Muhammad Asif Javed, MS

CONTACT

[email protected]

923224209422

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 25, 2025
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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